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An explorative and feasibility study of Venetoclax combined with Tamoxifen in patients with relapsed/refractory Diffuse Large B-cell Lymphoma

Primary objectives1. To assess the safety of Tam added to Ven. Venetoclax will be dosed at 800 mg once daily. After 2 days of venetoclax, tamoxifen will be orally administrated in a ramp-up phase (2 days 10mg, 2 days 20mg, to a final dose of 40 once…

A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients with Relapsed or Refractory Malignancies

The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…

A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of
Venetoclax Plus Ibrutinib in Subjects with T-Cell Prolymphocytic Leukemia

The primary objective is to demonstrate the efficacy in subjects with R/R T-PLL treated with venetoclax plus ibrutinib.

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…

Short-term combined acalabrutinib and venetoclax treatment of newly diagnosed patients with CLL at high risk of infection and/or early treatment, who do not fulfil IWCLL treatment criteria for treatment. A randomized study with extensive immune phenotyping.

This study has been transitioned to CTIS with ID 2024-511072-33-00 check the CTIS register for the current data. The aim is thereby to reduce the risk of serious infections and the need for regular CLL treatment.

Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with
Mantle Cell Lymphoma

Primary Objective: Safety Run-in Period:To evaluate the occurrence of tumor lysis syndrome (TLS) and doselimiting toxicities (DLTs) with the concurrent administration of ibrutinib and venetoclax.Randomization Phase:To evaluate whether the…

A prospective, multicenter, phase-II trial of ibrutinib plus venetoclax in physically fit patients with creatinine clearance >= 30 ml/min who have relapsed or refractory chronic lymphocytic leukemia (RR-CLL) with or without TP53 aberrations;HOVON 141 CLL / VIsion Trial of the HOVON and Nordic CLL study groups

This study has been transitioned to CTIS with ID 2023-510557-42-00 check the CTIS register for the current data. The primary objective: - Evaluate efficacy of ibrutinib + venetoclax (VI) in terms of proportion of patients fulfilling the criteria for…

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…

First line treatment with VeNEtoclaX and ibruTinib induction followed by obinutuzumab intenSificaTion Exclusively in CLL/SLL Patients not in complete remission and/or with detectable bone marrow minimal residual disease (NEXT STEP trial)

Primary objective- To evaluate the efficacy of 6 cycles ibrutinib/obinutuzumab in converting patients who are not in CR or who have detectable MRD on combination ibrutinib and venetoclax in uMRD (BM) CR Secondary objectives- To explore the kinetics…

REtreatment with VEnetoclax and Acalabrutinib after venetoclax Limited duration (REVEAL)
A prospective, multicenter, phase-II trial of venetoclax plus acalabrutinib in patients who have relapsed after first line venetoclax + anti-CD20 mAb treatment for chronic lymphocytic leukemia (CLL or SLL)

This study has been transitioned to CTIS with ID 2023-505449-18-00 check the CTIS register for the current data. Primary objective• To evaluate efficacy of acalabrutinib/venetoclax (AV) in terms of undetectable minimal residual disease (uMRD)…

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 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…

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 Ib/II, open label study evaluating the safery and pharmacokinetics of GDC-0199 (ABT-199) in combination with Rituximab (R) or Obinutuzumab (G) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with B Cell non-hodgkin's lymphoma (NHL) and DLBCL

The primary objective of the Phase I portion of the study is the following:* To estimate the maximum tolerated dosing schedule for venetoclax given in combination with R-CHOP or G-CHOP to patients with B-cell NHL, either previously untreated or…

A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax
in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic
Syndrome (Higher-Risk MDS)

This study has been transitioned to CTIS with ID 2023-507153-16-00 check the CTIS register for the current data. To assess the efficacy of venetoclax in combination with AZA compared to placebo with AZA in treatment-naive higher-risk MDS.

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, 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…

Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT-199) in Relapsed/Refractory Subjects with Chronic Lymphocytic Leukemia (CLL)

The primary objective of this study is to evaluate the efficacy of venetoclax monotherapy in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL).