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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).

This study has been transitioned to CTIS with ID 2022-500439-35-00 check the CTIS register for the current data. The primary objective of the study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus…

A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML

This study has been transitioned to CTIS with ID 2023-510160-12-00 check the CTIS register for the current data. To assess if venetoclax combined with FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall…

A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigator*s Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation

This study has been transitioned to CTIS with ID 2023-509349-11-00 check the CTIS register for the current data. Primary objective: To determine the efficacy of the combination of acalabrutinib and venetoclax without obinutuzumab (AV; Arm A), or…

A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Primary:• To compare the efficacy of zanubrutinib (also known as BGB-3111) versus ibrutinib as measured by overall response rate determined by investigator assessment Secondary:• To compare the efficacy of zanubrutinib versus ibrutinib as measured…

A Randomized, Open-label, Phase 3 study of the Combination of Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab for the First-line Treatment of Subjects with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

This study has been transitioned to CTIS with ID 2023-503469-49-00 check the CTIS register for the current data. Primary ObjectiveThe primary objective of the study is to assess progression-free survival (PFS) from treatment with ibrutinib plus…

A PHASE 1B/2 OPEN-LABEL, RANDOMIZED STUDY OF 2 COMBINATIONS OF ISOCITRATE
DEHYDROGENASE (IDH) MUTANT TARGETED THERAPIES PLUS AZACITIDINE: ORAL AG-120 PLUS SUBCUTANEOUS AZACITIDINE AND ORAL AG-221 PLUS SC AZACITIDINE IN SUBJECTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA HARBORING AN IDH1 OR AN IDH2 MUTATION, RESPECTIVELY, WHO ARE NOT CANDIDATES TO RECEIVE INTENSIVE INDUCTION CHEMOTHERAPY

This study has been transitioned to CTIS with ID 2024-511722-31-00 check the CTIS register for the current data. Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when…

A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of
ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk
Chronic Lymphocytic Leukemia

Therapy:The investigational product, ACP-196, will be supplied as hardgelatin capsules for oral administration.Commercially available ibrutinib (IMBRUVICA®) will be used asthe reference therapy.Objectives: Primary Objective:To assess whether ACP-196…

A Phase 3, Randomized, Double-blind, Active-Control Study of pelabresib (CPI0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

This study has been transitioned to CTIS with ID 2023-507954-34-00 check the CTIS register for the current data. Primary• To determine the efficacy of pelabresib + ruxolitinib compared with placebo + ruxolitinibKey Secondary• To determine the effect…

Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study (TARGET Study)

To address whether the individualized fludarabine conditioning reduces the incidence of severe viral infections at day 100 within the context of an αβTCR / CD19 depleted transplantation regimen.

European Intergroup Trial on panobinostat maintenance after HSCT for high-risk AML and MDS - A randomized, multicenter phase III study to assess the efficacy of panobinostat maintenance therapy vs. standard of care following allogeneic stem cell transplantation in patients with high-risk AML or MDS (ETAL-4 / HOVON-145)

Primary objective* To determine the efficacy of panobinostat maintenance therapy versus standard of care administered to patients with high-risk MDS or AML in complete hematologic remission after an allogeneic hematologic stem cell transplantation (…

A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of midostaurin to 10-day decitabine in UNFIT (i.e. HCT-CI >= 3) adult AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients.
A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT- AML/high-risk MDS patients.

This study has been transitioned to CTIS with ID 2023-503829-18-00 check the CTIS register for the current data. Primary objectives:- To assess in a randomized comparison the effect of midostaurin added to 10-day decitabine treatment on the…

A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered with Chemotherapy versus Chemotherapy Alone in Patients with Relapsed/Refractory Acute Myeloid Leukemia

The purposes of this clinical trial are to:• Test if trial participants taking uproleselan with standard chemotherapy medicines live longer than those taking standard chemotherapy alone. • Test if the number of trial participants achieving disease…

A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy

This study has been transitioned to CTIS with ID 2022-502478-18-00 check the CTIS register for the current data. To compare OS between gilteritinib and midostaurin in combination with induction therapy and consolidation therapy followed by one-year…

A prospective, open-label, multicenter randomized phase-II trial to evaluate the efficacy and safety of a sequential regimen of Gazyvaro (obinutuzumab) followed by obinutuzumab and venetoclax, followed by either standard venetoclax maintenance or MRD guided venetoclax maintenance in first-line patients with CLL and unfit for FCR-like regimens. (GIVE trial)

This study has been transitioned to CTIS with ID 2024-511048-22-00 check the CTIS register for the current data. -Primary objective- To separately study the efficacy, defined as MRD negative bone marrow and no progression according to the IWCLL…

A phase 3 multicenter, randomized, prospective, open-label trial of standard chemoimmunotherapy (FCR/BR) versus rituximab plus venetoclax (RVe) versus obinituzumab (GA101) plus venetoclax (GVe) versus obinituzumab plus ibrutinib plus venetoclax (GIVe) in fit patients with previously untreated chronic lymphocytic leukemia (CLL) without Del (17p) or TP53 mutation.

The primary objective of the study is to evaluate the efficacy of obinutuzumab(GA101) plus venetoclax (GVe) versus standard chemoimmunotherapy (BR/FCR)[concerning MRD negativity measured by flow cytometry in peripheral blood (PB)at month 15] and…

ALLTogether1- A Treatment study protocol of the ALLTogether Consortium for children and young adults (0-45 years of age) with newly diagnosed acute lymphoblastic leukaemia (ALL)

This study has been transitioned to CTIS with ID 2022-501050-11-01 check the CTIS register for the current data. The primary objective of ALLTogether is to improve survival and quality of survival in children and young adults with acute…

Protocol for treatment of children and adolescents with acute myeloid leukemia 0-18 years

This study has been transitioned to CTIS with ID 2024-518254-16-00 check the CTIS register for the current data. The primary aim of the NOPHO-DBH AML 2012 study is to improve EFS and OS in children with AML. To improve outcome, an intensified…

HOVON 132 AML / SAKK 30/13, Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score >4.5)

See above

CHIP-AML22 Master protocol: An open label complex clinical trial in newly diagnosed pediatric de novo AML patients - a study by the NOPHO-DBSHIP consortium

This study has been transitioned to CTIS with ID 2023-504999-25-00 check the CTIS register for the current data. To investigate wether the treatment of children and adolescents with AML can be improvedby means of:1) improved risk-group adapted…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Primary:• To compare the efficacy of magrolimab + venetoclax + azacitidine versus placebo + venetoclax + azacitidine in patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy as measured by…