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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.

A PHASE I/II, MULTICENTER, OPEN-LABEL, MULTI-ARM STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF IDASANUTLIN IN COMBINATION WITH EITHER CHEMOTHERAPY OR VENETOCLAX IN THE TREATMENT OF PEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LEUKEMIAS OR SOLID TUMORS.

This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…

A prospective Phase I/IIa, open-label, multicenter trial to evaluate the safety and efficacy of oNKord®, an off-the-shelf, ex vivo-cultured allogeneic NK cell preparation, in subjects with acute myeloid leukemia who are in morphologic complete remission with measurable residual disease and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation.

Primary ObjectivesThe primary objectives are:• The primary safety objective is to evaluate the safety and tolerability of the infusion of up to three doses of oNKord®• The primary efficacy objective is to assess the cumulative incidence of MRD…

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…

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…

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 Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation

Primary Objectives:Phase 1 Primary Objective** To determine the RP2D of ponatinib (tablet and AAF) in combination with chemotherapy.Phase 2 Primary Objective* * To determine the efficacy of ponatinib in combination with chemotherapy as measured by…

A Phase Ib study of Vyxeos® (liposomal daunorubicin and cytarabine) in combination with Clofarabine in children with relapsed/refractory AML, ITCC-092

This study has been transitioned to CTIS with ID 2023-508050-26-00 check the CTIS register for the current data. Primary objective:•To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with…

Vaccination response to pneumococcal antigen as novel predictor for successful tyrosine kinase inhibitor discontinuation in chronic myeloid leukemia.

To assess whether an adequate response to pneumococcal antigen, as a marker of overall humoral immune system reactivity, predicts sustained TFR. An adequate response to pneumococcal antigen will be defined as achieving anti-pneumococcal IgG levels…

Infusion of ex vivo-generated allogeneic natural killer cells in combination with subcutaneous IL-2 in patients with acute myeloid leukemia: a phase I/IIa study*

This study has been transitioned to CTIS with ID 2024-515357-16-00 check the CTIS register for the current data. The study is divided in two phases.The primary objective of phase I of the study is to evaluate the safety and toxicity of the infusion…

A Phase 1 and 2a open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of LAVA-051 in patients with relapsed or refractory chronic lymphocytic leukemia, multiple myeloma or acute myeloid leukemia

Primary Objective:Part 1 Dose Escalation• To investigate the safety and tolerability of LAVA-051 in patients with relapsed/refractory CLL, MM, or AML. • To determine the RP2D of LAVA-051 in patients with relapsed/refractory CLL, MM or AML.Part 2…

A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

This study has been transitioned to CTIS with ID 2023-504828-25-00 check the CTIS register for the current data. Main objective Monotherapy Cohorts (R/R CLL):• Identify the RP2D and the MTD of epcoritamab• Evaluate the safety and tolerability of…

An open-label, randomized clinical trial on teicoplanin infection prophylaxis in pediatric patients with acute myeloid leukemia

This study has been transitioned to CTIS with ID 2023-506546-23-00 check the CTIS register for the current data. Objectives safety run-in: The primary objective is:• To assess the safety of i.v. teicoplanin prophylaxis three times per week with a…

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

This study has been transitioned to CTIS with ID 2023-506945-42-00 check the CTIS register for the current data. Primary* Evaluate the safety and tolerability of SEA-CD70* Identify the maximum tolerated dose (MTD) or recommended expansion dose of…

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.

Methionin-low diet in acute leukemia patients, a phase I pilot

Safety of a methionine-low diet in patients with AML

International Study for Treatment of High Risk Childhood Relapsed ALL 2010 - A randomized Phase II Study Conducted by the Resistant Disease Committee of the International BFM Study Group.

This study has been transitioned to CTIS with ID 2024-513070-21-00 check the CTIS register for the current data. Primary objectives: Improvement of CR2 rates after induction with ALL R3 with bortezomib versus withoutbortezomib in HR relapsed ALL…

A Phase 1 Trial to Assess the Mass Balance, Absolute Bioavailability, and Pharmacokinetics of 14C ASTX660 in Healthy Volunteers

The purpose of this study is to investigate how safe the new compound ASTX660 is and how well it is tolerated when it is administered to healthy volunteers. ASTX660 has been administered to humans before. It has also been previously tested in the…

A phase 1, open-label, randomized, 2-period, 2-sequence, crossover study to evaluate the bioequivalence of Bosutinib pediatric capsule and the commercial tablet formulations in healthy participants under fed condition

The purpose of this study is to investigate how quickly and to what extent bosutinib is absorbed and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of bosutinib administered as a capsule will be compared to the…