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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 Multicenter Phase 1, Open-Label Study of DCC-2618 to Assess Safety, Tolerability, Efficacy, and Pharmacokinetics in Patients with Advanced Malignancies

Escalation PhasePrimary ObjectivesThe primary objectives of this study are to:• Determine the safety and tolerability of oral DCC-2618• Determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oral DCC-261Secondary…

Microsampling for therapeutic drug monitoring of imatinib, dasatinib, nilotinib, gilteritinib, midostaurin, and venetoclax

The primary objective is to perform a clinical validation of dried blood spot microsampling of imatinib, dasatinib, nilotinib, gilteritinib, midostaurin, and venetoclax. The secondary objective is to test the feasibility of home monitoring (…

A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults with Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

This study has been transitioned to CTIS with ID 2023-506136-32-00 check the CTIS register for the current data. Primary:Dose Escalation• Evaluate the safety and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory…

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

This study has been transitioned to CTIS with ID 2024-513759-34-00 check the CTIS register for the current data. Primary ObjectivesPhase 2The primary objectives of Phase 2 are:• To evaluate short- and long-term safety and tolerability of SNDX 5613…

A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy in subjects with DIPSS - intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and previously treated with ruxolitinib

The primary objective of the study is to evaluate the percentage of subjects with at least 35%spleen volume reduction in the fedratinib and the BAT arms.The secondary objectives are:• To evaluate the percentage of subjects with at least 50%…

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…

A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy (CCTL019G2201J)

This study has been transitioned to CTIS with ID 2023-508081-15-00 check the CTIS register for the current data. Primary: - To evaluate the efficacy of tisagenlecleucel therapy as measured by the overall survival (OS)- To evaluate the efficacy of…

A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia

This study has been transitioned to CTIS with ID 2023-507669-24-00 check the CTIS register for the current data. To evaluate the safety and tolerability of acalabrutinib monotherapy in subjects with treatment-naive or relapsed/refractory chronic…

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 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

The primary objective of Phase 1 is to evaluate the safety of KTE-X19.The primary objective of Phase 2 is to evaluate the efficacy of KTE-X19, as measured by the overall complete remission rate defined as complete remission (CR) and complete…

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…

A dose-escalation, open label phase I study to assess the safety, feasibility and preliminary efficacy of HA-1H TCR modified T cells, MDG1021, in patients with relapsed or persistent hematologic malignancies after allogeneic hematological stem cell transplantation with or without unmanipulated donor lymphocyte infusion.

Primary objectives for the dose-escalation part of the study: • To assess the safety and tolerability of HA-1H TCR transduced T cells (MDG1021) in patients with relapsed or persistent hematologic malignancies after allo-HSCT with or without…

Phase III Clinical Trial for CPX-351 in Myeloid Leukemia in Children with Down Syndrome 2018

This study has been transitioned to CTIS with ID 2022-501457-37-00 check the CTIS register for the current data. Primary Objective:- Achieving an event-free survival, which is not inferior to the ML-DS 2006 trial (87±3%)Secondary Objective(s):-…

A Phase 1/2, First-in-Human, Dose Escalation Study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART) Bi-Specific Antibody-Based Molecule, in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome

Primary Objective: To assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR/CRhSecondary Objectives:To describe response rate, duration of response, event-free…

International phase I/II expansion trial of the MEK inhibitor selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult
Acute Lymphoblastic Leukaemia

Phase IPrimary Objective- To define the recommended phase II dose (RP2D) of selumetinib/dexamethasone combination in adult and paediatric patients with relapsed/refractory, RAS pathway mutant ALLSecondary Objectives- To evaluate safety and…