Acute Myeloid Leukemia (AML)
MP0533-CP101
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Title in German |
Eine Studie mit MP0533 bei Patienten mit Blutkrebs |
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Title in English |
A phase 1/2a, first-in-human, open-label, multicenter study of MP0533 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB2) |
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Description |
This study examines the study drug MP0533, which is being used in patients for the first time. Only patients diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) can take part in the study. MP0533 is designed to selectively bind to and kill cancer cells in the blood and bone marrow. It is expected to activate the body's immune system and trigger an immune response against the cancer to kill the cancer cells. Therefore, MP0533 offers a novel and innovative treatment option to be tested in humans. MP0533 has been shown to be safe in animal studies. Treatment with MP0533 aims to address the high unmet medical need for patients with recurrent or difficult-to-treat leukemia or myelodysplastic syndrome. In this study, we examine how safe the new study drug MP0533 is and how well it works. We are testing MP0533 at various dosages to define the safest and most efficient dosing regimen of study drug MP0533 for future studies. We also want to learn more about the distribution and concentration of the study drug in the blood and bone marrow and how it affects the body, its effect on the cancer cells, and the ability of the study drug to trigger an unwanted immune response in the body. The study is a multicenter international study. The participating centers are located in Europe (Netherlands and Switzerland). Two locations in Switzerland were selected to take part in the present clinical study. |
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Phase/Biobank/ect. |
1/2a |
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Head of Clincial Trial |
Prof. Dr. Thomas Pabst |
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Study-Nurse |
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Back-up |
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Back-up |
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Status |
temp. closed for patient recruitment since 21.04.2024 |
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BASEC Nummer |
2022-01615 |
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KOFAM |
SNCTP000005268 |
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EudraCT No. |
EUCTR2022-002432-31 |
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WHO-Register-Nummer |
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Insel-Nummer |
5294 |
OncoVerity OV-AML-1231
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Title in German |
Eine Studie zu Cusatuzumab in Kombination mit einer Standardbehandlung bei Patienten mit neu diagnostizierter AML, die nicht für eine Intensivtherapie infrage kommen |
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Title in English |
A multicenter, open-label, randomized, phase 2 study of venetoclax and azacitidine plus cusatuzumab versus venetoclax and azacitidine alone in newly diagnosed AML patients who are not candidates for intensive therapy |
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Description |
This is a multicenter Phase 2 study in which both you and your investigator will know which group you are randomly assigned to in order to evaluate the efficacy, safety and effects of venetoclax/azacitidine/cusatuzumab (VAC) compared to venetoclax/azacitidine (VA) in patients with newly diagnosed acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy. The study will be conducted in Europe and North America, with approximately 120 patients randomly assigned. Enrolled participants will be randomly assigned in a 2:1 ratio to treatment with VAC or VA. The group of study participants will include individuals at higher risk for adverse events according to the University of Colorado VA-specific risk model by enrolling participants at unfavorable, intermediate and favorable risk in a 3:1:1 ratio, respectively. Multiple tests for blood and bone marrow analysis will be performed. Cycles will continue every 28 days indefinitely until disease progression, switch to an alternative line of treatment (including HSCT), unacceptable toxicity, investigator or participant decision to discontinue, or death. The safety of cusatuzumab will be evaluated by physical examinations, clinical laboratory tests, electrocardiograms (ECG) and adverse event (AE) monitoring. An independent Data Monitoring Committee (DMC) will be established to ensure the ongoing safety of subjects enrolled in this study, to review futility and final analyses, and to review ongoing study objectives. |
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Phase |
2 |
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Head Clinical Trial |
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Study Nurse |
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Back-up |
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Back-up |
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Status |
open for patient recruitment: 23.10.2024 |
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BASEC-Nummer |
2024-00879 |
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KOFAM |
SNCTP000006119 |
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WHO-Register-Nummer |
EUCTR2024-510991-19 |
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Insel-Nummer |
5814 |
RAPID-01 Trial
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Title in German |
Individualisierung der Standard Therapie bei Rückfall oder ungenügendem Ansprechen einer akuten myeloischen Leukämie mit Hilfe einer neuen Technologie namens Pharmakoskopie |
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Title in English |
Pharmacoscopy-guided clinical standard-of-care in relapsed/refractory acute myeloid leukemia, a randomized phase-2 clinical trial |
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Description |
In this study, we are investigating whether standard treatments for relapsed/resistant acute myeloid leukemia (AML) can be tailored to individual patients. This involves using a new technology called pharmacoscopy (PCY) to test the effect of different standard therapies on AML cells using a patient's blood or bone marrow sample. With this study, we aim to find out whether PCY can improve treatment choice. Patients will be randomly assigned to one of two groups. Half of the patients will be assigned to the PCY group, and the other half to the control group. In the PCY group, the treatment decision will be supported by PCY. In the control group, the treatment decision will be made by the investigator. Therefore, the treatment decision for the control group will not be supported by PCY. The study procedure is the same in both groups. There will be a total of five study visits, each lasting between 60 and 90 minutes. Additional blood or bone marrow will be collected for PCY at the beginning of the study. The individual study duration is three months. The entire course of study is scheduled to last two years. |
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Phase/Biobank/etc. |
2 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
open for patient recruitment: March 19, 2025 |
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BASEC-Nummer |
2023-D0089 |
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KOFAM |
SNCTP000005776 |
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WHO-Register-Nummer |
NCT06138990 |
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Insel-Nummer |
5967 |
Myelodysplastic Syndromes (MDS)
IMerge – GRN163L
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Titel in German |
Eine Studie zur Beurteilung von Imetelstat (GRN163L) bei transfusionsabhängigen Patienten mit Myelodysplastischem Syndrom (MDS) der IPSS-Risikoklassen niedrig oder intermediär 1, das rezidiviert/refraktär gegenüber einer Behandlung mit einer Erythropoese-stimulierenden Substanz (ESA) ist |
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Titel in English |
A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment |
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Description |
Dies ist eine randomisierte, doppelblinde, placebokontrollierte Phase 3 Studie zum Vergleich der Wirksamkeit von Imetelstat versus Placebo, hinsichtlich Unabhängigkeit von Erythrozyten-Transfusionen. |
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Phase/Biobank/etc. |
Phase 2/3 |
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Studienleitung |
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Study-Nurse |
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Back-up |
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Status |
active, not recruiting |
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BASEC Nummer |
2020-02056 |
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KOFAM |
SNCTP000005028 |
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WHO-Register-Nummer |
NCT02598661 |
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Insel-Nummer |
4732 |
LUSPLUS-Studie
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Title in German |
Eine open-label, einarmige Phase-IIIb-Studie zur Bewertung der Wirksamkeit und Sicherheit von Luspatercept bei Patienten mit MDS mit niedrigem Risiko und ringsideroblastischem Phänotyp (MDS-RS) |
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Title in English |
A phase IIIb, open-label, single arm study to evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and ring-sideroblastic phenotype (MDS-RS) |
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Description |
The study aims to compare 70 non-del(5q) LR-MDS patients. ESAs refractory/relapsed/intolerant/ineligible or refractory/relapsed to HMAs or LEN will be included and receive treatment with luspatercept. |
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Phase |
3b |
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Head Clinical Trial |
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Study-Nurse |
Nicole Hadorn / Raisa Daniela Diesel |
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Back-up |
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Status |
active, not recruiting |
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BASEC-number |
2022-00877 |
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Kofam-number |
SNCTP000005315 |
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WHO-register-number |
NCT05181592 |
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Insel-Number |
5328 |
Myeloproliferative Neoplasms (MPN)
t-MN
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Title in German |
Therapiebedingte myeloische Neoplasien nach zytotoxischer Behandlung: Risikobewertung, Patientencharakterisierung und prognostische Faktoren |
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Title in English |
Therapy-related myeloid neoplasms after cytotoxic treatment: risk assessment, patients characterization and prognostic factors |
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Descpription |
The study takes advantage of the Swiss Personalized Health Network initiative (SPHN), and in particular the Swiss Personalized Oncology network (SPO), to screen a large population of patients (more than 100,000) that have received chemotherapy and/or radiotherapy at four university hospitals in Switzerland. After screening, we expect to find 100 - 200 t-MN cases that will be used to discover new insights on the risks of developing t-MNs and the profile of t-MN patients. After local validation and data completion for t-MN cases, we will calculate t-MN risk and describe t-MN patient characteristics and outcomes. |
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Head Clinical Trial |
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Study nurse |
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Back-up |
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Status |
active, not recruiting |
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BASEC number |
2023-00475 |
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Kofam number |
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WHO registry number |
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Insel number |
5547 |
IL33
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Title in German |
Die Rolle der IL-33/ST2-Signalübertragung bei myeloproliferativen Neoplasien |
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Title in English |
The role of IL-33/ST2 signaling in myeloproliferative neoplasms |
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Description |
The objectives of the study are to investigate the role of IL-33/ST2 in human MPN by 1) prospectively analyzing patients with MPN (newly diagnosed or with established MPN requiring follow-up biopsy); 2) retrospectively analyzing archived BM samples with staining for IL-33 or IL-33 receptor (also called ST2) (or associated markers) and comparison with disease progression and in particular extent of BM fibrosis; and 3) analyzing the role of IL-33/ST2 in myelofibrosis by complementing pathologic analyses with in vitro mechanistic studies involving the culture of primary bone marrow fibroblasts |
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Phase |
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Head Clinical Trial |
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Study Nurse |
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Back-up |
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Status |
active, recruitment paused |
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BASEC-Nummer |
2016-01949 |
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KOFAM |
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WHO-Register-Nummer |
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Insel-Nummer |
3556 |
JAKi-Res
JAKi-Res
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Title in German |
Mechanismen der erworbenen Resistenz gegen die Behandlung mit JAK2-Inhibitoren bei Patienten mit myeloproliferativen Neoplasmen |
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Title in English |
Molecular mechanism of acquired resistance to clinical JAK2 inhibitor treatment in patients with myeloproliferative neoplasms |
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Description |
Myeloproliferative neoplasms (MPNs) are chronic blood cancers characterized by excessive production of myeloid cells, driven primarily by mutations activating the JAK2 signaling pathway. Treatment with JAK2 inhibitors initially controls disease symptoms effectively; however, many patients develop resistance over time, severely limiting therapeutic options and negatively impacting prognosis. This project aims to uncover molecular mechanisms underlying acquired resistance to JAK2 inhibitor therapy in MPN patients. We will employ a multi-omics approach, integrating whole exome sequencing, ATAC-seq for epigenetic profiling, RNA sequencing for transcriptomic analysis, and phosphoproteomics to identify active signaling pathways in resistant cells. Patient-derived blood samples from distinct clinical groups—untreated, short-term treated, long-term treated responders, and symptomatic resistant patients—will provide comparative insights. Identified resistance mechanisms will then be validated using ex vivo patient cell cultures and patient-derived xenograft mouse models. Ultimately, this study seeks to generate comprehensive molecular profiles of resistant disease, identify actionable targets, and lay the foundation for novel combination therapies aimed at overcoming or preventing resistance, thus significantly improving clinical outcomes and patient quality of life. |
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Phase |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
open for patient recruitment: 02.03.2024 |
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BASEC number |
2025-00308 |
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Insel number |
6013 |
MPN-register
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Title in German |
Etablierung eines Registers für Patienten mit myeloproliferativen Neoplasien (MPN) in der Schweiz (MPN-Register) |
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Title in English |
Establishment of a registry for patients with myeloproliferative neoplasms (MPN) in Switzerland (MPN registry) |
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Description |
Mit dem schweizerischen MPN-Register werden gesundheitsbezogene Daten von Patienten mit MPN bei Erstdiagnose und im Verlauf der Erkrankung standardisiert und systematisch erfasst. Die Ziele des MPN-Registers umfassen die Förderung der klinischen Forschung bei MPN sowie die Verbesserung der Versorgung von Patienten mit MPN in der Schweiz. Mit Hife der Datensammlung im MPN-Register sollen epidemiologische Analysen durchgeführt werden, Analysen zu diagnostischen und therapeutischen Massnahmen bei Erstdiagnose, im Hinblick auf den Krankheitsverlauf und auf das Gesamtüberleben erfolgen, und letztlich die Umsetzung internationaler Empfehlungen bezüglich Diagnostik und Therapie im medizinischen Alltag untersucht werden. |
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Phase |
|
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Head Clinical Trial |
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Study Nurse |
Pascale Julia Tanner / Raisa Daniela Diesel |
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Back-up |
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Status |
active, recruiting |
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BASEC number |
- |
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KOFAM number |
- |
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WHO registry number |
- |
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Insel number |
5578 |
TDM-JAKI
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Title in German |
Therapeutisches Arzneimittelmonitoring von Immunsuppressiva als neues Instrument der Präzisionsmedizin für akute und chronische Entzündungskrankheiten |
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Title in English |
Therapeutic drug monitoring of immunosuppressive agents as novel precision medicine instrument for acute and chronic inflammatory disorders |
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Description |
The objective of the study is to optimize the drug exposure of immunosuppressant Janus-Kinase Inhibitors (JAKi) used to treat autoimmune diseases by developing an individualized monitoring of JAKi in blood. JAKis represent a new therapeutic approach to control the JAK-STAT cell-signaling pathway. JAKis are used in the treatment of inflammatory pathologies. The project aims to establish a benchmark for target concentrations of JAKi according to the pathologies treated in order to optimize therapeutic efficacy while limiting adverse effects. In onco-hematological diseases, JAKIs are indicated for graft versus host disease, myelofibrosis, essential polycythemia and thrombocythemia. Using modeling approaches (population pharmacokinetics, system pharmacology), the impact of genetic and environmental factors and interactions with other treatments will be analyzed and will be used to optimize drug exposure and propose personalized administrations of JAKis. |
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Phase |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
|
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Status |
active, recruiting |
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BASEC number |
2023-00904 |
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Kofam number |
- |
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WHO registry number |
- |
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Insel number |
5948 |
Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Hodgkin Lymphoma (HL)
CLL 17
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Title in German |
Klinische multizentrische, randomisierte, prospektive, open-label Phase 3 Studie mit Ibrutinib-Monotherapie versus zeitlich befristet Venetoclax plus Obinutuzumab versus zeitlich befristet Venetoclax plus Ibrutinb bei Patienten mit bisher unbehandelter chronischer lymphatischer Leukämie (CLL) |
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Title in English |
A phase 3 multicentre, randomized, prospective, open-label trial of Ibrutinib monotherapy versus fixed-duration Venetoclax plus Obinutuzumab versus fixed-duration Venetoclax plus Ibrutinib in patients with previously untreated chronic lymphocytic leukaemia (CLL) |
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Description |
Past studies have demonstrated the superiority of BCRi and venetoclax over chemoimmunotherapy in previously untreated CLL/SLL. However, these therapies have not yet been directly compared with each other. Of particular interest is the comparison of purely oral treatments against therapies with parenteral administration of antibodies as well as the comparison of long-term therapy leading to intolerance or progression against temporary therapy. In this study, three treatment arms, randomized 1:1:1, are compared against each other: |
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- Ibrutinib (I): monotherapy until intolerance or progression, |
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- Venetoclax+Obinutuzumab (VG): 6 cycles of venetoclax+obinutuzumab + 6 cycles of venetoclax, |
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- Venetoclax+Ibrutinib (VI): 3 cycles of ibrutinib, 12 cycles of venetoclax+ibrutinib. |
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Patients with previously untreated CLL/SLL with an indication for treatment according to iwCLL criteria are included. The primary endpoint is progression-free survival. Key secondary endpoints include response, minimal residual disease and overall survival. |
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Phase/Biobank etc. |
Phase 3 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
active, not recruiting |
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BASEC Nummer |
2021-01861 |
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KOFAM |
SNCTP000004689 |
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WHO-Register-Nummer |
NCT04608318 |
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Insel-Nummer |
5025 |
IELSG48
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Title in German |
Phase 3, interventionelle, multizentrische, open-label, randomisierte Studie zum Vergleich von Rituximab plus Zanubrutinib mit Rituximab Monotherapy in vorherig unbehandeltem symptomatischen, splenischem Marginalzonenlymphom (SMZL). |
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Title in English |
Phase 3, interventional, multicentre, open label, randomized study comparing rituximab plus zanubrutinib to rituximab monotherapy in previously untreated, symptomatic splenic marginal zone lymphoma (RITZ) |
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Description |
The goal of this clinical trial is to compare the efficacy and tolerability of the combination of two medicinal products, rituximab, and zanubrutinib, compared to rituximab monotherapy in patients with Splenic Marginal Zone Lymphoma (SMZL), previously untreated and who need systemic treatment. The main questions it aims to answer are: 1) Is the combination rituximab and zanubrutinib a more effective therapy than rituximab monotherapy? and 2) Is the combination therapy, rituximab and zanubrutinib, well tolerated? Study participants will be put into one of the two treatment groups (rituximab and zanubrutinib or rituximab alone) for a maximum of two years and will undergo regular visits until three years from treatment start. Approximately 120 subjects will be randomized in a 1:1 ratio to receive zanubrutinib and rituximab (Treatment Arm A) or rituximab (Treatment Arm B). The study will include a Screening Phase, a Treatment Phase, and a Follow-Up Phase. Subjects with investigator-confirmed progressive disease (PD) according to the Lugano 2014 criteria or unacceptable toxicity, or investigator/subject decision must discontinue study treatment. Patients who complete the treatment and patients who will discontinue treatment for any reason will enter the Follow-up Phase. The Response Follow-up Phase will occur for subjects who complete the treatment or discontinue for reasons other than disease progression and will include efficacy assessments every 24 weeks until investigator-assessed disease progression. Subjects with PD during the Response Follow-up Phase will continue to be followed in the Survival Follow-up Phase. An Independent Data Monitoring Committee (IDMC) will be responsible for independent review of the interim safety analysis on the first 20 enrolled patients in the experimental arm. |
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Phase |
Phase 3 |
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Head Clinical Trial |
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Study Nurse |
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Back-up |
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Status |
active, recruiting |
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BASEC number |
2023-02309 |
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KOFAM number |
SNCTP000005808 |
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WHO registry number |
NCT05735834 |
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Insel number |
5672 |
MK-1026-003
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Title in German |
Eine Phase 2-Studie zur Evaluation der Wirksamkeit und Verträglichkeit von MK-1026 bei Patienten mit malignen hämatologischen Neoplasien |
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Title in English |
A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies |
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Description |
MK-1026 (Nemtabrutinib) ist ein oraler, reversibler, nicht-kovalenter ATP kompetitiver Inhibitor der BTK. Das Medikament hemmt die BTK unabhängig von C481 und ist daher sowohl bei Wildtyp als auch bei C481 mutierter BTK aktiv. In dieser Phase 2-Studie wird die Wirksamkeit (primärer Endpunkt: OR) und Verträglichkeit von MK-1026 in 8 Kohorten mit rezidivierter oder refraktärer CLL oder NHL untersucht: |
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A: CLL/SLL rezidiviert oder refraktär nach Vortherapie mit einem kovalenten, irreversiblen BTKi, einem BCL2i und einem PI3Ki (geschlossen), |
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B: CLL/SLL rezidiviert oder refraktär nach Vortherapie mindestens einer Vortherapie und BTKi-naiv (geschlossen), |
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C: CLL/SLL mit 17p Deletion rezidiviert oder refraktär nach mindestens einer Vortherapie (geschlossen), |
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D: Richter-Tansformation rezidivert oder refraktär nach mindestens einer Vortherapie (für die Richter-Transformation) (offen), |
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E: MCL rezidiviert oder refraktär nach Chemoimmunotherapie und einem kovalenten irreversiblen BTKi (geschlossen), |
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F: MZL (inklusive splenisches, nodales und extranodales MZL) rezidiviert oder refraktär nach mindestens einer vorangegangenen systemischen Therapie, einschliesslich eines Anti-CD20-basierten Regimes. (offen), |
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G: FL rezidiviert oder refraktär nach Chemoimmunotherapie, Immunmodulatoren (z.B. Lenalidomid + Rituximab) und einen PI3Ki (closed), |
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H: WM rezidiviert oder refraktär nach Chemoimmunotherapie oder einen kovalenten irreversiblen BTKi (closed), |
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J: CLL/SLL rezidiviert oder refraktär nach Vortherapie mit einem kovalenten/irreversiblen BTK-Inhibitor (BTKi) und einem BCL2-Inhibitor (BCL2i) (beide Therapieklassen sind erforderlich). Die zusätzliche Anwendung eines nicht-kovalenten/reversiblen BTKi ist zulässig, sofern die Krankheit nach einer solchen Therapie rezidivierte oder refraktär war. CLL-Patient:innen müssen entweder eine Behandlung mit einem PI3K-Inhibitor (PI3Ki) erhalten und darauf nicht angesprochen haben, diesen nicht vertragen haben oder als ungeeignet für eine PI3Ki-Therapie eingestuft worden sein (offen). |
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Phase/Biobank/etc. |
Phase 2 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
active, recruiting |
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BASEC number |
2022-00139 |
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KOFAM number |
SNCTP000004864 |
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WHO registry number |
NCT04728893 |
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Insel-Nummer |
5093 |
Nurix NX-5948-301
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Title in German |
NX-5948-301 Die Behandlung von erwachsenen Patientinnen und Patienten mit einem B-Zell-Lymphom, die einen Rückfall haben oder die auf eine andere Behandlung nicht ansprechen, mit dem Wirkstoff NX-5948, einem Hemmer des Enzyms Bruton-Tyrosinkinase. Eine Phase-I-Studie mit unterschiedlichen Dosierungen |
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Title in English |
A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies |
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Description |
This study aims to determine the effect of the study drug NX-5948 on people with B-cell lymphoma or B-cell leukemia. This study is international and is being conducted at several study centers in countries within the European Union, Switzerland, the United Kingdom, and the United States. A total of 532 people are expected to participate. The study consists of three parts: 1. In the first part, the dose of the test drug is gradually increased (dose escalation). 2. In the second part, the safety and efficacy of selected optimal doses are investigated (safety dose expansion). 3. In the third part, the efficacy and selected doses are investigated in people with CLL/SLL (cohort expansion). This study enrolls patients suffering from B-cell lymphoma or B-cell leukemia whose disease has not responded to previous therapy (therapy-resistant lymphoma/therapy-resistant leukemia) or whose disease has returned after a period of improvement (relapse/recurrence). This study investigates whether different doses of the investigational drug NX-5948 are safe and well-tolerated, and whether NX-5948 is effective in treating B-cell lymphomas. Participation in this study consists of four sequential steps: 1. Screening: Patients undergo various examinations to determine their suitability for participation in the study. 2. Treatment: Patients take the investigational drug NX-5948 at regular intervals and are examined regularly. 3. Safety monitoring: After receiving the last dose of NX-5948, patients are followed up three times within 30 days. 4. Long-term follow-up for a maximum of five years. |
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Phase/Biobank/etc. |
1 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
open for patient recruitment: 02.04.2025 |
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BASEC-Nummer |
2024-01865 |
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KOFAM |
SNCTP000006326 |
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WHO-Register-Nummer |
NCT05131022 |
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Insel-Nummer |
5931 |
SAKK 34/17
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Title in German |
Ibrutinib-lead-in gefolgt von Venetoclax plus Ibrutinib bei Patienten mit rezidivierter/ refraktärer chronischer lymphatischer Leukämie. Eine multizentrische, open-label, Phase II Studie. |
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Title in English |
Ibrutinib lead-in followed by venetoclax plus Ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia. A multicentric, open-label, phase II trial. |
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Description |
Venetoclax and ibrutinib are both oral drugs whose tolerability when used in combination is not inferior to single agents. Venetoclax and ibrutinib have complementary activity in clearing the disease across anatomical compartments. Ibrutinib is more active in lymph nodes rather than blood where a small lymphocytosis might persist despite continuous treatment. Conversely, venetoclax appears to be more active in blood and bone marrow (BM) rather than lymph nodes. By combining ibrutinib with venetoclax, cells can be mobilized from tissues into the bloodstream by ibrutinib and killed in the blood by venetoclax. Consistently, the venetoclax-ibrutinib combination can achieve undetectable minimal residual disease (MRD-neg) in a sizable proportion of patients. Gentle debulking obtained with a lead-in phase of ibrutinib monotherapy may allow starting venetoclax when the disease has been reshaped in a size that fits for low-risk of tumor lysis syndrome (TLS), a rare adverse event (AE) of venetoclax. MRD-guided treatment duration may allow patients achieving a negative status to gain drug-free intervals and less medicalization, and may avoid all the potential, and not yet completely known implications of continuous therapy on long-term safety, drug interactions, quality of life, compliance to treatment, and economic sustainability. The primary objective of the trial is to assess efficacy after 30 cycles of trial treatment. |
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Phase/Biobank/ect. |
Phase 3 |
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Head Clinical Trial |
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Study-Nurse |
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Back-up |
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Status |
active, not recruiting |
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BASEC Nummer |
2018-02034 |
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KOFAM |
SNCTP000003200 |
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WHO-Register-Nummer |
NCT03708003 |
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Insel-Nummer |
3880 |
SAKK 38/23 LIBERTY
|
Title in German |
|
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Title in English |
SAKK 38/23 LIBERTY: Liquid biopsy to diagnose and monitor central nervous system (CNS) involvement in high-risk B cell non-Hodgkin lymphoma |
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Beschreibung |
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Phase |
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Head Clinical Trial |
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Study Nurse |
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Back-up |
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Status |
open for recruiting: 01.07.2024 |
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BASEC number |
2023-01964 |
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WHO registry number |
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Insel number |
5698 |
VeRVe
|
Title in German |
Beobachtungsstudie zum Gebrauch von Venetoclax bei Patienten mit chronischer lymphatischer Leukämie (CLL) unter real-life Bedingungen in Österreich, Deutschland und der Schweiz |
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Title in English |
Observational study of the use of venetoclax in patients with chronic lymphocytic leukemia (CLL) under real-life setting in Austria, Germany, and Switzerland |
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Description |
This observational study examines the use of venetoclax in the approved indications in patients with chronic lymphocytic leukemia (CLL) under real-life conditions. |
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Venetoclax is administered as part of clinical routine. Clinical and laboratory data on tolerability and effectiveness will be collected. |
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In addition, molecular genetic studies from blood samples will be carried out to assess the clonal evolution of CLL cells, the TP53 clone size and minimal residual disease under venetoclax. The primary endpoint is best response at 12 months. |
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Phase/Biobank/etc. |
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|
Head Clinical Trial |
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|
Study-Nurse |
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|
Back-up |
|
|
Status |
active, not recruiting |
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BASEC Nummer |
2018-01541 |
|
KOFAM |
|
|
WHO-Register-Nummer |
NCT03342144 |
|
Insel-Nummer |
3882 |
TreoMel Trial (IIT)
|
Title in German |
Vergleich von Treosulfan mit Melphalan gegen Melphalan alleine bei einer hochdosierten Chemotherapie vor autologer Transplantation bei Patienten mit einem Multiplen Myelom |
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Title in English |
comparing treosulfan and melphalan with melphalan alone as conditioning regimen for autologous stem cell transplantation (ASCT) in myeloma patients |
|
Description |
Aim of the study: You have previously been treated with medication for myeloma disease. Your doctor has informed you in detail about the type of myeloma disease and the entire treatment protocol. Your treatment now also includes an intensive therapy phase, the so-called high-dose chemotherapy with the transplantation of your own (autologous) stem cells (autologous stem cell transplantation). Stem cells are precursor cells of normal blood cells. These stem cells normally develop into red blood cells (erythrocytes), white blood cells (leukocytes) and blood platelets (thrombocytes) in the bone marrow. After chemotherapy and treatment with growth factors (G-CSF), stem cells can pass from the bone marrow into the blood. Such stem cells can then be removed from the blood through your veins and collected (stem cell collection). Such a stem cell collection will be carried out on you. This is followed by particularly strong chemotherapy, a so-called high-dose chemotherapy, followed by an autologous (own) stem cell transplant. The purpose of such high-dose chemotherapy is to destroy any remaining myeloma cells as completely as possible. For several decades, autologous stem cell transplantation (ASCT) after high-dose chemotherapy (HDCT) has been the standard in first-line therapy for patients with multiple myeloma if they are sufficiently fit. Nevertheless, practically all patients develop a relapse of their myeloma disease even after this intensive therapy. Therefore, intensive efforts are being made to improve high-dose chemotherapy for this patient group. The present study at the Inselspital in Bern is intended to clarify in a 1:1 comparison whether additional administration of the drug treosulfan (Trecondi®) can improve the results of high-dose melphalan therapy. We would like to show that more myeloma patients can achieve the goal of complete remission. A total of 120 myeloma patients are needed, including 60 patients in each of the two treatment arms. The drug Trecondi® contains the active ingredient treosulfan. It is administered at a dose of 14 g/m2 as an infusion over 2 hours, for three days in a row. Selection: We are asking you because all people can take part who suffer from myeloma disease and, after standard chemotherapy for initial treatment (induction), high-dose chemotherapy with the transplantation of their own (autologous) stem cells (autologous stem cell transplantation) be received. Anyone suffering from multiple myeloma can take part in this study. They must also be between 18 and 75 years old. However, patients with myeloma who are not considered suitable for high-dose chemotherapy by their treating doctors due to other illnesses are not allowed to take part. |
|
Phase |
2 |
|
Head Clinical Trial |
|
|
Study-Nurse |
|
|
Status |
open for patient recruitment since 06.06.2023 |
|
BASEC Nummer |
2022-01923 |
|
KOFAM |
SNCTP000005441 |
|
WHO-Register-Nummer |
NCT05636787 |
|
Insel-Nummer |
5441 |
EBMT CAR-T CIC221
EBMT CAR-T CIC221
|
Title in German |
Register der Europäischen Gesellschaft für Blut- und Knochenmarktransplantation (EBMT) |
|
Title in English |
Registry data processing framework |
|
Description |
Purpose of the Registry The primary function of the Registry is to collect clinical data for research and to improve the safety and effectiveness of treatments and the quality of care. Ultimately, it's about saving the lives of patients with blood cancer and other life-threatening diseases. |
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Phase/Biobank/ect. |
Register |
|
Studienleiter |
|
|
Study-Nurse |
|
|
Status |
active since 15.07.2021 |
|
BASEC Nummer |
2021-00020 |
|
Insel-Nummer |
4812 |
TreoMel Trial (IIT)
|
Title in German |
Vergleich von Treosulfan mit Melphalan gegen Melphalan alleine bei einer hochdosierten Chemotherapie vor autologer Transplantation bei Patienten mit einem Multiplen Myelom |
|
Title in English |
comparing treosulfan and melphalan with melphalan alone as conditioning regimen for autologous stem cell transplantation (ASCT) in myeloma patients |
|
Description |
Aim of the study: You have previously been treated with medication for myeloma disease. Your doctor has informed you in detail about the type of myeloma disease and the entire treatment protocol. Your treatment now also includes an intensive therapy phase, the so-called high-dose chemotherapy with the transplantation of your own (autologous) stem cells (autologous stem cell transplantation). Stem cells are precursor cells of normal blood cells. These stem cells normally develop into red blood cells (erythrocytes), white blood cells (leukocytes) and blood platelets (thrombocytes) in the bone marrow. After chemotherapy and treatment with growth factors (G-CSF), stem cells can pass from the bone marrow into the blood. Such stem cells can then be removed from the blood through your veins and collected (stem cell collection). Such a stem cell collection will be carried out on you. This is followed by particularly strong chemotherapy, a so-called high-dose chemotherapy, followed by an autologous (own) stem cell transplant. The purpose of such high-dose chemotherapy is to destroy any remaining myeloma cells as completely as possible. For several decades, autologous stem cell transplantation (ASCT) after high-dose chemotherapy (HDCT) has been the standard in first-line therapy for patients with multiple myeloma if they are sufficiently fit. Nevertheless, practically all patients develop a relapse of their myeloma disease even after this intensive therapy. Therefore, intensive efforts are being made to improve high-dose chemotherapy for this patient group. The present study at the Inselspital in Bern is intended to clarify in a 1:1 comparison whether additional administration of the drug treosulfan (Trecondi®) can improve the results of high-dose melphalan therapy. We would like to show that more myeloma patients can achieve the goal of complete remission. A total of 120 myeloma patients are needed, including 60 patients in each of the two treatment arms. The drug Trecondi® contains the active ingredient treosulfan. It is administered at a dose of 14 g/m2 as an infusion over 2 hours, for three days in a row. Selection: We are asking you because all people can take part who suffer from myeloma disease and, after standard chemotherapy for initial treatment (induction), high-dose chemotherapy with the transplantation of their own (autologous) stem cells (autologous stem cell transplantation) be received. Anyone suffering from multiple myeloma can take part in this study. They must also be between 18 and 75 years old. However, patients with myeloma who are not considered suitable for high-dose chemotherapy by their treating doctors due to other illnesses are not allowed to take part. |
|
Phase |
2 |
|
Head Clinical Trial |
|
|
Study-Nurse |
|
|
Status |
open for patient recruitment since 06.06.2023 |
|
BASEC Nummer |
2022-01923 |
|
KOFAM |
SNCTP000005441 |
|
WHO-Register-Nummer |
NCT05636787 |
|
Insel-Nummer |
5441 |