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Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination with Chemotherapy in Pediatric Patients from 28 Days to Less than 18 Years of Age with Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse.

Primary objective:To evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute…

A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignancies

Primary objectives:-Evaluate the safety and tolerability of AMG 330 in adult subjects with relapsed/refractory acute myeloid leukemia (R/R A ML), MRD+ AML and MDS-Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg,…

A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral, covalent, menin inhibitor, in adult patients with acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL)

This study has been transitioned to CTIS with ID 2024-515744-23-00 check the CTIS register for the current data. The primary objectives of the study are to:Determine the OBD(s) and RP2D's) of BMF-219 monotherapy administered daily based on…

Clinical aspects and molecular mechanisms in large granular lymphocyte (LGL) leukemia - IDeAL study

Overall objective of this IDeAL study is to unravel the biological heterogeneity of LGL leukemia and to correlate this with the clinical features. More specific objectives are: 1. Build a LGL leukemia registry (clinical features and lab data).2. Set…

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 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 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 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…

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…

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…

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…

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).

Clinical and biological follow-up of children and young adutls prior to, during, and after CAR T-cell therapy, prospective single-centre study (CABRIO)

To determine the real world response to standard of care CAR T-cell therapy, in order to better understand the intrinsic and extrinsic factors related to treatment success or failure.

Assessing Overall Survival, Quality of Life, Frailty, Comorbidity Indexes, Healthcare Usage, and Pharmacoeconomics in Elderly Patients with Acute Myeloid Leukemia

Primary Objective:- To assess and describe Quality of Life throughout a patients treatment trajectorySecondary Objective(s):- To assess and describe how frail unselected real world AML patients are at diagnosis using geriatric screening tools (G8, 6…