Clinical Trials to Hematological Neoplasms (Blood and Lymph Gland Cancer)

Myeloid Neoplasms

Acute Myeloid Leukemia (AML)

Title in German	Individualisierung der Standard Therapie bei Rückfall oder ungenügendem Ansprechen einer akuten myeloischen Leukämie mit Hilfe einer neuen Technologie namens Pharmakoskopie
Title in English	Pharmacoscopy-guided clinical standard-of-care in relapsed/refractory acute myeloid leukemia, a randomized phase-2 clinical trial
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.
Phase/Biobank/etc.	2
Head Clinical Trial	Prof. Dr. med. Thomas Pabst
Research Assistant	Sarina Huber
Back-up	Anke Klingenberg
Status	open for patient recruitment: March 19, 2025
BASEC-Nummer	2023-D0089
KOFAM	SNCTP000005776
WHO-Register-Nummer	NCT06138990
Insel-Nummer	5967

Myelodysplastic Syndromes (MDS)

German title	Randomisierte, doppelblinde, placebokontrollierte adaptive Phase-2/3-Studie zur Bewertung der Wirksamkeit und Sicherheit von Momelotinib bei Patienten mit VEXAS-Syndrom
English title	A Randomized Phase 2/3, Double-blind, Placebo-Controlled Adaptive Study Evaluating the Efficacy and Safety of Momelotinib in Participants with VEXAS Syndrome
Description	Die ATLAS-Studie ist eine internationale, randomisierte, doppelblinde Phase-2/3-Studie zur Evaluierung von Momelotinib bei Patienten mit VEXAS-Syndrom. Dabei handelt es sich um eine seltene, lebensbedrohliche entzündlich-blutbildende Erkrankung ohne derzeit zugelassene Therapieoptionen. Momelotinib, ein selektiver JAK-Inhibitor, der bereits für Myelofibrose zugelassen ist, wird nun erstmals in dieser Indikation untersucht. Als primäre Endpunkte dienen klinische Ansprechraten sowie die Erfassung unerwünschter Ereignisse.
Phase	2/3
PI	Prof. Dr. med. Natalia Baran, PhD
Study-Nurse	Nicole Hadorn
Back-up	Wuddri Rim/ Pascale Julia Tanner
Status	Upcoming
BASEC number	i. B.
KOFAM	i. B.
WHO registry number	EU-CT: 2025-524416-11-00; NCT: NCT07569081
Insel number	i. B.

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
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
Description	Dies ist eine randomisierte, doppelblinde, placebokontrollierte Phase 3 Studie zum Vergleich der Wirksamkeit von Imetelstat versus Placebo, hinsichtlich Unabhängigkeit von Erythrozyten-Transfusionen.
Phase/Biobank/etc.	Phase 2/3
Studienleitung	PD Dr. med. Michael Daskalakis
Study-Nurse	Nicole Hadorn
Back-up	Wuddri Rim/ Pascale Julia Tanner
Status	active, not recruiting
BASEC Nummer	2020-02056
KOFAM	SNCTP000005028
WHO-Register-Nummer	NCT02598661
Insel-Nummer	4732

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)
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)
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.
Phase	3b
Head Clinical Trial	Dr. med. Annatina Sarah Schnegg-Kaufmann
Study-Nurse	Nicole Hadorn
Back-up	Wuddri Rim / Pascale Julia Tanner
Status	active, not recruiting
BASEC-number	2022-00877
Kofam-number	SNCTP000005315
WHO-register-number	NCT05181592
Insel-Number	5328

Title in German	Eine Studie zu Elritercept zur Behandlung von Anämie bei Erwachsenen mit myelodysplastischen Syndromen (MDS) mit sehr niedrigem, niedrigem oder intermediärem Risiko, die regelmässige Bluttransfusionen benötigen
Title in English	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)
Description	Diese Studie untersucht Elritercept zur Behandlung von Anämie bei Erwachsenen mit myelodysplastischen Syndromen (MDS) niedriger Risikokategorien, die regelmässige Bluttransfusionen benötigen. Als investigatives Medikament wird Elritercept im Vergleich zu Placebo eingesetzt. Teilnehmer werden randomisiert im Verhältnis 2:1 entweder Elritercept oder Placebo zugeordnet und erhalten die Substanz alle vier Wochen als subkutane Injektion. Die Studie ist vierfach-verblindet durchgeführt. Primärer Endpunkt ist der Prozentsatz der Teilnehmer, die Transfusionsunabhängigkeit für mindestens 24 Wochen erreichen. Sekundäre Outpoints umfassen TI für mindestens 8 Wochen bei hohem Transfusionsaufkommen sowie Sicherheitsparameter.
Phase/Biobank/etc.	3
PI	Prof. Dr. med. Natalia Baran, PhD
Study-Nurse	Wuddri Rim
Back-up	Pascale Julia Tanner/ Nicole Hadorn
Status	Upcoming
BASEC Nummer	2026-01149
KOFAM	HumRes68530
WHO-Register-Nummer	EU-CT: 2024-516009-22; NCT06499285
Insel-Nummer	6394

Myeloproliferative Neoplasms (MPN)

Title in German	Eine Phase-3-Studie zu INCA033989 im Vergleich zur besten verfügbaren Therapie bei Teilnehmern mit essentieller Thrombozythämie
Title	A Phase 3, Randomized, Open-Label Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia Previously Treated With Cytoreductive Therapy
Description	In der randomisierten Phase-3-Studie EXCALIBUR-ET2 wird die Wirksamkeit und Sicherheit des Prüfpräparats INCA033989 im Vergleich zur besten verfügbaren Therapie bei Patientinnen und Patienten mit essentieller Thrombozythämie und einer CALR-Mutation untersucht. Die Teilnehmenden wurden zuvor bereits mit einer zytoreduktiven Therapie behandelt. Primäres Ziel ist das Erreichen einer dauerhaften klinisch-hämatologischen Antwort.
	Sekundär werden unter anderem molekulare Veränderungen wie die Reduktion der mutCALR-Variantenallelfrequenz, das Auftreten von Nebenwirkungen sowie die Lebensqualität anhand spezifischer Symptom- und Erschöpfungsskalen erfasst.
Phase/Biobank/etc.	3
PI	Prof. Dr. med. Sara C. Meyer, PhD
Study nurse	Wuddri Rim
Back-up	Pascale Julia Tanner/ Nicole Hadorn
Status	Upcoming
BASEC number	i. B.
KOFAM	HumRes68511
WHO registry number	NCT07623200
Insel number	i. B.

Title in German	A Phase 3, Randomized, Open-Label Study of INCA033989 Versus Best Available Therapy in Participants With Myelofibrosis and a CALR Mutation Previously Treated With JAK Inhibitors (EXCALIBUR-MF2)
Title in English	Eine Phase-3-Studie zu INCA033989 im Vergleich zur besten verfügbaren Therapie bei Teilnehmern mit Myelofibrose und CALR-Mutation
Beschreibung	In der randomisierten Phase-3-Studie EXCALIBUR-MF2 wird die Wirksamkeit und Sicherheit des Prüfpräparats INCA033989 im Vergleich zur besten verfügbaren Therapie bei Patientinnen und Patienten mit Myelofibrose und einer CALR-Mutation untersucht. Die Teilnehmenden wurden zuvor bereits mit einem JAK-Inhibitor behandelt.
Phase/Biobank/etc.	3
Studienleitung	Prof. Dr. med. Sara C. Meyer, PhD
Study-Nurse	Wuddri Rim
Back-up	Pascale Julia Tanner/ Nicole Hadorn
Status	Upcoming
BASEC Nummer	i. B.
KOFAM	i. B.
WHO-Register-Nummer	i. B.
Insel-Nummer	i. B.

Title in German	Eine Studie zur Untersuchung der Wirkung und Sicherheit von INCB160058 bei Patient:innen mit Blutkrebs
Title in English	A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms
Description	This study evaluates the safety, tolerability, and dose-limiting toxicities (DLTs) of the investigational agent INCB160058 in participants with myeloproliferative neoplasms (MPNs), including Myelofibrosis (MF), Polycythemia vera (PV), and Essential thrombocythemia (ET) with JAK2V617F mutation. The study aims to determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE). INCB160058 is administered either as monotherapy or in combination with Ruxolitinib, particularly in participants with MF who have an inadequate response to prior ruxolitinib therapy. The study includes a dose-escalation phase to assess safety and identify dose-limiting toxicities, followed by a dose-expansion phase to further evaluate safety, tolerability, pharmacokinetics, and preliminary clinical activity at the selected dose level(s).
Phase	1
PI	Prof. Dr. med. Sara C. Meyer, PhD
Study Nurse	Nicole Hadorn
Back-up	Wuddri Rim/ Pascale Julia Tanner
Status	aktiv, nicht rekrutierend
BASEC number	2025-02136
KOFAM	SNCTP000006803
WHO registry number	NCT06313593
Insel number	6286

JAKi-Res

Title in German	Mechanismen der erworbenen Resistenz gegen die Behandlung mit JAK2-Inhibitoren bei Patienten mit myeloproliferativen Neoplasmen
Title in English	Molecular mechanism of acquired resistance to clinical JAK2 inhibitor treatment in patients with myeloproliferative neoplasms
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.
Phase
Head Clinical Trial	Prof. Dr. med. Sara C. Meyer, PhD
Study-Nurse	Pascale Julia Tanner
Back-up	Wuddri Rim
Status	open for patient recruitment: 02.03.2024
BASEC number	2025-00308
Insel number	6013

Title in German	Eine Phase-1/2a-Studie, offen, multizentrisch, zur Bewertung der Sicherheit, Verträglichkeit, Pharmakokinetik und Wirksamkeit des JAK2-Inhibitors Ruxolitinib in Kombination mit dem MEK-Inhibitor Trametinib bei Patienten mit fortgeschrittenen myeloproliferativen Neoplasien (MPN)
Title in English	A Phase 1/2a, Open-Label, Multicenter Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the JAK2 Inhibitor Ruxolitinib Combined with the MEK Inhibitor Trametinib in Patients with Advanced Myeloproliferative Neoplasms (MPN)
Description	Diese offene, multizentrische Phase-1/2a-Studie untersucht die Kombination zweier zielgerichteter Medikamente bei Patienten mit fortgeschrittenen myeloproliferativen Neoplasien (MPN). Geprüft werden der JAK2-Inhibitor Ruxolitinib und der MEK-Inhibitor Trametinib in einer kombinierten Therapie.
	Primäre Ziele der Studie sind Sicherheit und Verträglichkeit dieser Wirkstoffkombination. Zudem werden pharmakokinetische Parameter erhoben, also wie die Substanzen vom Körper aufgenommen und verstoffwechselt werden. Erste Hinweise auf die Wirksamkeit der Behandlung sollen ebenfalls gewonnen werden.
Phase/Biobank/etc.	1 / 2a
PI	Prof. Dr. med. Sara C. Meyer, PhD
Study nurse	Wuddri Rim
Back-up	Pascale Julia Tanner/ Nicole Hadorn
Status	Upcoming
BASEC number	i. B.
KOFAM	i. B.
WHO registry number	i. B.
Insel number	i. B.

Title in German	Navtemadlin als Zusatztherapie zu Ruxolitinib bei Patienten mit Myelofibrose
Title in English	A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib (POIESIS)
Description	This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving. Study duration will be 50 months (approximately 26 months enrollment and 24 months of participation)
Phase	3
PI	Prof. Dr. med. Sara C. Meyer, PhD
Study Nurse	Pascale Julia Tanner
Back-up	Wuddri Rim/ Nicole Hadorn
Status	active, not recruiting
BASEC-Nummer	2025-D0086
KOFAM	Link www.humanforschung-schweiz.ch
WHO registry number	NCT06479135
Insel number	6273

Title in German	Eine Phase-3-Studie zu Pelabresib (DAK539) und Ruxolitinib bei Myelofibrose (MF)
Title in English	A Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients with Myelofibrosis who are JAK inhibitor naive
Description	Die MANIFEST-3 ist eine Phase-3-Studie, die die Kombination aus dem neuen Medikament Pelabresib (DAK539) und dem bereits etablierten JAK-Inhibitor Ruxolitinib bei Patienten mit Myelofibrose untersucht. Die Studie wird randomisiert und verblindet durchgeführt.
	Als primäre Endpunkte werden insbesondere die Verbesserung von Krankheits-Symptomen (TSS50-Reaktion) und die Verkleinerung der Milz (SVR35-Reaktion) nach 24 Wochen bewertet. Zusätzlich werden Sicherheit, Verträglichkeit sowie langfristige Ergebnisse wie Gesamtüberleben und progressionsfreies Überleben erfasst.
Phase/Biobank/etc.	3
Studienleitung	Prof. Dr. med. Sara C. Meyer, PhD
Study-Nurse	Wuddri Rim
Back-up	Pascale Julia Tanner/ Nicole Hadorn
Status	aktive, recruiting
BASEC number	2026-00179
KOFAM	HumRes68180
WHO registry number	NCT: NCT07357727; EU-CT: 2025-523555-66-00
Insel number	6373

Title in German	Etablierung eines Registers für Patienten mit myeloproliferativen Neoplasien (MPN) in der Schweiz (MPN-Register)
Title in English	Establishment of a registry for patients with myeloproliferative neoplasms (MPN) in Switzerland (MPN registry)
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.
Phase
Head Clinical Trial	Prof. Dr. med. Sara C. Meyer, PhD
Study Nurse	Pascale Julia Tanner
Back-up	Wuddri Rim
Status	active, recruiting
BASEC number	-
KOFAM number	-
WHO registry number	-
Insel number	5578

Title in German	Therapeutisches Arzneimittelmonitoring von Immunsuppressiva als neues Instrument der Präzisionsmedizin für akute und chronische Entzündungskrankheiten
Title in English	Therapeutic drug monitoring of immunosuppressive agents as novel precision medicine instrument for acute and chronic inflammatory disorders
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.
Phase
Head Clinical Trial	Prof. Dr. med. Sara C. Meyer, PhD
Study-Nurse	Nicole Hadorn
Back-up	Wuddri Rim / Wuddri Rim / Pascale Julia Tanner
Status	active, recruiting
BASEC number	2023-00904
Kofam number	-
WHO registry number	-
Insel number	5948

Title in German	Studientitel: Eine multizentrische Phase-II-Studie zu TL-895 bei Patienten mit Myelofibrose, indolenter systemischer Mastozytose, monoklonalem Mastzellaktivierungssyndrom oder nicht monoklonalem Mastzellaktivierungssyndrom
Title in English	A Phase 2 Multicenter Study of TL-895 in Subjects with Myelofibrosis, Indolent Systemic Mastocytosis, Monoclonal Mast Cell Activation Syndrome, or Non-Monoclonal Mast Cell Activation Syndrome
Beschreibung	This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
	Our site is participating in Cohort 5, Phase C, which includes patients with Indolent Systemic Mastocytosis (ISM). In this phase, patients will be randomized 2:1 to receive TL-895 or placebo, in addition to the best supportive care.
	The treatment includes a 28-week double-blind period, after which participants will transition to an open-label TL-895 treatment. Treatment arms for patients with ISM: A) Arm 1 (N = 40): TL-895 150 mg twice daily, continuous. B) Arm 2 (N = 20): Placebo twice daily, continuous The study uses 28-day treatment cycles and aims to assess the safety and effectiveness of TL-895 alongside optimized supportive care.
Phase	2
PI	Prof. Dr. med. Sara C. Meyer, PhD
Study nurse	Nicole Hadorn
Back-up	Wuddri Rim/ Pascale Julia Tanner
Status	active, recruiting
BASEC Nummer	2025-02126
KOFAM	www.humanforschung-schweiz.ch
WHO registry number	NCT04655118
Insel number	6283

Lymphatic Neoplasms

Acute Lymphocytic Leukemias (ALL)

Currently no open clinical trials.

Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Hodgkin Lymphoma (HL)

German title	AVANTGARDE Nicht-interventionelle Studie zur Beschreibung der Behandlungsmuster und klinischen Ergebnisse in der Praxis bei therapienaiven Patienten mit chronischer lymphatischer Leukämie, die mit Acalabrutinib + Venetoclax ± Obinutuzumab als Erstlinientherapie über einen festgelegten Zeitraum behandelt wurden.
English title	AVANTGARDE Non-Interventional Study to Describe Real-World Treatment Patterns and Clinical Outcomes in Treatment-Naïve Chronic Lymphocytic Leukemia Patients Treated with Fixed-Duration Acalabrutinib + Venetoclax ± Obinutuzumab as First-Line Therapy
Description	Diese nichtinterventionelle, multinationale, prospektive Kohortenstudie untersucht das Gesamtansprechen auf die Erstlinientherapie mit Acalabrutinib-Kombination (+Venetoclax ± Obinutuzumab) bei mindestens 250 behandlungsnaiven Patientinnen und Patienten mit chronischer lymphatischer Leukämie (CLL) in Europa und Kanada. Klinische Daten werden routinemässig aus Krankenakten erhoben, ergänzt durch patientenberichtete Endpunkte (PRO) zu Beginn, am Therapieende sowie drei Monate danach. Die Nachbeobachtung dauert mindestens 24 Monate nach Behandlungsende. Als Endpunkte werden das real-world progressionsfreie Überleben (rwPFS), die real-world Time to Next Treatment (rwTTNT) und das real-world Overall Survival (rwOS) nach 24, 36 und 48 Monaten ausgewertet.
Phase	4
PI	Dr. med. Martin Andres
Study Nurse	Nicole Hadorn
Back-up	Pascale Julia Tanner/ Wuddri Rim
Status	active, recruiting
BASEC Nummer	2025-02643
KOFAM
WHO registry number
Insel number	6414

German title	Eine Phase-3, offene, randomisierte Studie zur Bewertung der Sicherheit und Wirksamkeit von BGB-16673 im Vergleich zu Pirtobrutinib bei Patienten mit rezidivierter/refraktärer chronischer lymphatischer Leukämie oder kleinem lymphatischem Lymphom
English title	A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Description	The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi). BGB-16673 is a potent, selective, and orally available BTK-targeted protein degrader. Preliminary clinical data demonstrated an acceptable safety profile and promising efficacy in various B-cell malignancies including CLL/SLL. Patients will receive treatment until unacceptable toxicity or unequivocal progressive disease or any of the treatment discontinuation criteria is met, whichever occurs first.
Phase	3
PI	Dr. med. Martin Andres
Study Nurse	Wuddri Rim
Back-up	Nicole Hadorn/ Pascale Julia Tanner
Status	active, recruiting
BASEC number	2025-01594
KOFAM	www.humanforschung-schweiz.ch
WHO registry number	NCT06973187
Insel number	6274

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)
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)
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:
	- Ibrutinib (I): monotherapy until intolerance or progression,
	- Venetoclax+Obinutuzumab (VG): 6 cycles of venetoclax+obinutuzumab + 6 cycles of venetoclax,
	- Venetoclax+Ibrutinib (VI): 3 cycles of ibrutinib, 12 cycles of venetoclax+ibrutinib.
	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.
Phase/Biobank etc.	Phase 3
Head Clinical Trial	Dr. med. Martin Andres
Study-Nurse	Wuddri Rim
Back-up	Nicole Hadorn
Status	active, not recruiting
BASEC Nummer	2021-01861
KOFAM	SNCTP000004689
WHO-Register-Nummer	NCT04608318
Insel-Nummer	5025

German title	Vergleich von drei Therapien bei Patientinnen und Patienten mit bislang unbehandelter chronischer lymphatischer Leukämie (CLL) oder kleinzelligem lymphozytischen Lymphom (SLL)
English title	A phase 3 multicenter, randomised, prospective, open-label trial of fixed-duration (12 cycles) venetoclax/ obinutuzumab vs. fixed-duration (15 cycles) venetoclax/ pirtobrutinib vs. MRD-guided venetoclax/ pirtobrutinib in patients with previously untreated chronic lymphocytic leukaemia (CLL)/ small lymphocytic lymphoma (SLL) aiming to establish measurement of individual residual disease for adjustment of treatment duration to improve outcomes
Description	Comparison of Three Therapeutic Approaches in Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) - Time-limited therapy (12 cycles) with venetoclax and obinutuzumab - Time-limited therapy (15 cycles) with venetoclax and pirtobrutinib - Venetoclax and pirtobrutinib administered for a duration determined by the individual patient’s response; response is assessed through regular measurement of circulating tumor cells in peripheral blood (individual measurable residual disease, MRD) The objective is to utilize MRD status to guide treatment duration and thereby improve clinical outcomes.
	Chronic lymphocytic leukemia (CLL) is the most common adult leukemia in Switzerland, and small lymphocytic lymphoma (SLL) is a subtype of CLL. Multiple treatment options are available, and the choice of regimen and duration depends on disease stage and the biological characteristics of the malignant cells. Some patients receive fixed-duration therapy, whereas others are treated continuously; however, it remains uncertain which strategy yields superior outcomes.
	This study evaluates whether treatment outcomes in previously untreated CLL/SLL can be improved through measurable residual disease (MRD)–guided therapy. MRD (measurable residual disease) refers to the quantification of residual CLL cells in peripheral blood using sensitive laboratory methods. While MRD monitoring is standard in certain other hematologic malignancies, it is not yet routinely implemented in CLL.
	The trial compares three therapeutic approaches: (1) fixed-duration venetoclax plus obinutuzumab (12 cycles), (2) fixed-duration venetoclax plus pirtobrutinib (15 cycles), and (3) venetoclax plus pirtobrutinib administered for a variable duration determined by individual MRD response, with therapy discontinued once CLL cells are no longer detectable in peripheral blood. Venetoclax and obinutuzumab are approved for CLL treatment. Pirtobrutinib is approved in the European Union for relapsed CLL and in Switzerland for a different oncologic indication, but not for CLL. The overarching aim is to use MRD status to individualize treatment duration, optimize therapeutic efficacy, and further personalize patient care.
Phase	3
PI	Dr. med. Martin Andres
Study Nurse	Wuddri Rim
Back-up	Nicole Hadorn/ Pascale Julia Tanner
Status	active, recruiting
BASEC number	2025-01822
KOFAM	www.humanforschung-schweiz.ch
WHO registry number	EUCT: 2023-510294-34-00
Insel number	6275

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).
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)
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.
Phase	Phase 3
Head Clinical Trial	Dr. med. Martin Andres
Study Nurse	Wuddri Rim
Back-up	Nicole Hadorn / Pascale Julia Tanner
Status	active, not recruiting
BASEC number	2023-02309
KOFAM number	SNCTP000005808
WHO registry number	NCT05735834
Insel number	5672

Title in German	Eine Phase 2-Studie zur Evaluation der Wirksamkeit und Verträglichkeit von MK-1026 bei Patienten mit malignen hämatologischen Neoplasien
Title in English	A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies
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:
	A: CLL/SLL rezidiviert oder refraktär nach Vortherapie mit einem kovalenten, irreversiblen BTKi, einem BCL2i und einem PI3Ki (geschlossen),
	B: CLL/SLL rezidiviert oder refraktär nach Vortherapie mindestens einer Vortherapie und BTKi-naiv (geschlossen),
	C: CLL/SLL mit 17p Deletion rezidiviert oder refraktär nach mindestens einer Vortherapie (geschlossen),
	D: Richter-Tansformation rezidivert oder refraktär nach mindestens einer Vortherapie (für die Richter-Transformation) (geschlossen),
	E: MCL rezidiviert oder refraktär nach Chemoimmunotherapie und einem kovalenten irreversiblen BTKi (geschlossen),
	F: MZL (inklusive splenisches, nodales und extranodales MZL) rezidiviert oder refraktär nach mindestens einer vorangegangenen systemischen Therapie, einschliesslich eines Anti-CD20-basierten Regimes. (geschlossen),
	G: FL rezidiviert oder refraktär nach Chemoimmunotherapie, Immunmodulatoren (z.B. Lenalidomid + Rituximab) und einen PI3Ki (closed),
	H: WM rezidiviert oder refraktär nach Chemoimmunotherapie oder einen kovalenten irreversiblen BTKi (closed),
	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).
Phase/Biobank/etc.	Phase 2
Head Clinical Trial	Dr. med. Martin Andres
Study-Nurse	Wuddri Rim
Back-up	Nicole Hadorn / Pascale Julia Tanner
Status	active, recruiting
BASEC number	2022-00139
KOFAM number	SNCTP000004864
WHO registry number	NCT04728893
Insel-Nummer	5093

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.
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.
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.
Phase/Biobank/ect.	Phase 3
Head Clinical Trial	Dr. med. Martin Andres
Study-Nurse	Nicole Hadorn
Back-up	Wuddri Rim
Status	active, not recruiting
BASEC Nummer	2018-02034
KOFAM	SNCTP000003200
WHO-Register-Nummer	NCT03708003
Insel-Nummer	3880

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
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
Description	This observational study examines the use of venetoclax in the approved indications in patients with chronic lymphocytic leukemia (CLL) under real-life conditions.
	Venetoclax is administered as part of clinical routine. Clinical and laboratory data on tolerability and effectiveness will be collected.
	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.
Phase/Biobank/etc.
Head Clinical Trial	Dr. med. Martin Andres
Study-Nurse	Sebastian Mathes
Back-up
Status	active, not recruiting
BASEC Nummer	2018-01541
KOFAM
WHO-Register-Nummer	NCT03342144
Insel-Nummer	3882

Plasma Cell Neoplasms

Plasma Cell Myeloma, Immunoglobulin Light Chain (AL) Amyloidosis

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	Prof. Dr. Thomas Pabst
Study-Nurse	Anke Klingenberg
Status	open for patient recruitment since 06.06.2023
BASEC Nummer	2022-01923
KOFAM	SNCTP000005441
WHO-Register-Nummer	NCT05636787
Insel-Nummer	5441

Clinical Trials on Stem Cell Transplantation, Cellular Therapies and CAR-T

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.
Phase/Biobank/ect.	Register
Studienleiter	Prof. Dr. Thomas Pabst
Study-Nurse	Irene Reusser
Status	active since 15.07.2021
BASEC Nummer	2021-00020
Insel-Nummer	4812

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	Prof. Dr. Thomas Pabst
Study-Nurse	Anke Klingenberg
Status	open for patient recruitment since 06.06.2023
BASEC Nummer	2022-01923
KOFAM	SNCTP000005441
WHO-Register-Nummer	NCT05636787
Insel-Nummer	5441

Servicenavigation

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Clinical Trials to Hematological Neoplasms (Blood and Lymph Gland Cancer)

Myeloid Neoplasms

Acute Myeloid Leukemia (AML)

RAPID-01 Trial

Myelodysplastic Syndromes (MDS)

ATLAS

IMerge – GRN163L

LUSPLUS-Studie

RENEW

Myeloproliferative Neoplasms (MPN)

Excalibur-ET2

Excalibur-MF 2

INCB160058-101 (LIMBER-101)

JAKi-Res

JAKi-Res

JAK-MEK (IIT)

KRT-232-115 (POIESIS)

MANIFEST-3

MPN-register

TDM-JAKI

TL-895-201

Lymphatic Neoplasms

Acute Lymphocytic Leukemias (ALL)

Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Hodgkin Lymphoma (HL)

AVANTGARDE

BGB-16673-304

CLL 17

CLL 18 (MOIRAI-Trial)

IELSG48

MK-1026-003

SAKK 34/17

VeRVe

Plasma Cell Neoplasms

TreoMel Trial (IIT)

Clinical Trials on Stem Cell Transplantation, Cellular Therapies and CAR-T

EBMT CAR-T CIC221

EBMT CAR-T CIC221

TreoMel Trial (IIT)