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A Phase 2, multicenter, open-label study to evaluate the pharmacokinetics, pharmacodynamics,
safety and activity of azacitidine and to compare azacitidine to historical controls in pediatric
subjects with newly diagnosed advanced myelodysplastic syndrome or juvenile myelomonocytic
leukemia before hematopoietic stem cell transplantation

The primary objective is to assess the treatment effect on response rate (MDS: either completeremission [CR], partial remission [PR], or marrow CR; JMML: either clinical completeremission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28…

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT-330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged >= 66 years .

Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of selinexor added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…

A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib

To demonstrate the efficacy of ponatinib administered at 2 starting doses (30 and 15 mg QD) compared to nilotinib administered at 400 mg BID in patients with CP-CML who are resistant to imatinib, as measured by MMR by 12 months

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…

Efficacy and safety of an innate allogeneic haematopoietic stem cells transplantation
in patients with haematological malignancies

To test transplantation-related mortality after an innate allo-SCT defined as alpha/beta T-cell depleted stem cell support combined with a *low dose DLI*.

Therapeutic drug monitoring of asparaginase and methotrexate metabolism in childhood acute lymphoblastic leukemia.

The main objective of the study is to develop an optimal and individualized asparaginase treatment protocol. The study consist of four sub-studies. The objective of the population pharmacokinetic study is to get more insight in the pharmacokinetics…

A Phase 2 study for older adults with Acute Lymphoblastic Leukaemia

To identify a safe and tolerable standard of care protocol for patients >= 60 years old with de novo Acute Lymphoblastic Leukaemia (ALL).

Immunological monitoring and assessment of biomarkers predictive of clinical response to first-line treatment with bosutinib or imatinib in chronic phase chronic myeloid leukemia

In this laboratory study, we will examine the properties of leukemic stem cells and the immuno-modulatory effects of bosutinib and imatinib in newly diagnosed chronic phase CML patients. Further, we aim to study whether they have an impact on the…

A phase I, dose escalation study of S80880, a CD123 x CD3 *Dual Affinity Re-Targeting (DART)* bi-specific antibody-based molecule given as monotherapy in patients with acute leukaemias and other haematological malignancies expressing CD123

­The primary objective of this study is to determine the maximum tolerated dose (MTD) for the administration of S80880.Secondary objectivesTo evaluate the safety profile of S80880.To describe the pharmacokinetics (PK) profile of S80880 administered…

Effect of food on the pharmacokinetics of nilotinib in chronic myeloid leukemia: assessment of a tailored dose reduction (NiFo-study)

To evaluate the effect of real-life food consumption on the pharmacokinetics of nilotinib in CML patients

Decitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality risk

Primary objectives:• To assess early mortality risk (first 30 days after start of induction therapy) of treatment with decitabine-cytarabine in elderly patients with AML or high risk myelodysplastic syndrome (IPSS >=1.5) with a high risk of…

A Phase 1, Multinational Study of MCLA-117 in Acute Myelogenous Leukemia

Primary:To assess the safety and tolerability of MCLA-117, in order to determine the MTD/RP2D and frequency of administration.Secondary:- To assess the pharmacokinetic (PK) profile of MCLA-117 i.v. infusion- To investigate the pharmacodynamic (PD)…

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 I/II study of Bosutinib in pediatric patients with newly diagnosed chronic phase or resistant/intolerant Ph+ Chronic Myeloid Leukemia,ITCC-054/AAML1921

This study has been transitioned to CTIS with ID 2023-504311-32-00 check the CTIS register for the current data. Primary Objective phase 1:- To determine the Recommended Phase 2 Dose (RP2D) of bosutinib for R/I (RP2DR/I) and ND chronic phase (RP2DND…

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 randomized phase II multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in UNFIT (i.e. HCT-CI >= 3) AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients aged >= 66 years.
A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT-older AML/high-risk MDS patients

Primary objectives1. To assess in a randomized comparison the effect of Ibrutinib added to 10-day decitabine treatment on the cumulative CR/CRi rate after 3 cycles.Secondary objectives1. To assess the safety and tolerability of Ibrutinib added to 10…

A Randomized, Open-label, Controlled Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects with High-risk First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)

Primary Objective:• To evaluate event-free survival (EFS) after blinatumomab when compared to standard ofcare (SOC) chemotherapySecondary Objective(s):• To evaluate the effect of blinatumomab on overall survival (OS) when compared to SOCchemotherapy…

Prospective Analysis of an individualized dosing Regimen of ATG (Thymoglobulin) in Children Undergoing HCT: redUcing Toxicity and improving Efficacy * a single arm phase II study

To investigate whether an individualized dosing regimen for Thymoglobulin leads to a better immune reconstitution after HCT (definition as in primary endpoint), as compared to historically non-individualized treated patients receiving Thymoglobulin…

Potential HIV Cure by Stem Cell Transplantation

To gain insight in clinical, virological and immunological mechanisms and predictors of the eradication of HIV. To gain insight in the dynamics of the T cell HIV reservoir in which HIV is persisting. To gain insight in different levels of immune…

The changing over time of ascorbic acid after chemotherapy and the correlation between ascorbic acid and the recovery of the immune cells after chemotherapy in patients receiving intensive clinical chemotherapy for acute leukemia and high dose chemotherapy with autologous stem cell rescue and in outpatients receiving relatively mild chemotherapy for lung cancer and colon cancer.

The aim of this study is to evaluate the changing over time of AA levels in plasma and in leukocytes before and during chemotherapy treatment for several different groups of patients and compare that to healthy controls.