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Glucocorticoid induced HPA axis suppression in childhood acute lymphoblastic leukemia and lymphoma

To investigate the HPA axis function and the glucocorticoid receptor function after high-dose glucocorticoid therapy during treatment for childhood ALL and lymphoma. With these results, a more robust approach on glucocorticoid coverage during…

Infusion of ex vivo-cultured allogeneic NK cells in acute myeloid leukemia patients not eligible for stem cell transplantation (a phase I dose escalation study)

The primary aim of our study is to evaluate safety and toxicity of ex vivo-expanded NK cell infusions following a non-myeloablative conditioning regimen in elderly AML patients who are no candidates for allogeneic SCT. Moreover there is also a…

ADMINISTRATION OF HA-1 TCR TRANSDUCED VIRUS-SPECIFIC T-CELLS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS WITH HIGH-RISK LEUKEMIA (LUMC 2010-02)

Primary Objective• To investigate the feasibility and safety of administration of donor HA-1 TCR transduced virus-specific T-cells after allo-SCT.Secondary Objectives• To evaluate the persistence of donor HA-1 TCR transduced virus-specific T-cells…

A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy with Bortezomib (Velcade) in Patients with Multiple Myeloma in First or Second Relapse

The primary objective is to describe the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib versus standard retreatment with bortezomib in combination with dexamethasone on…

Open, non-controlled, dose escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability, and toxicity of volasertib in paediatric patients from 2 years to less than 18 years of age with acute leukaemia or advanced solid tumour, for whom no effective treatment is known

The objective is to define the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is…

10-day decitabine, fludarabine and 2 Gray TBI as conditioning strategy for poor and very poor risk AML in CR1. PLMA34 study

The primary objective of this study is to assess the feasibility (safety and efficacy) of addition of 10-day decitabine to the standard Seattle non-myeloablative conditioning regimen (3 days fludarabine 30 mg/m2 + 2 Gray TBI) prior to allogeneic HCT…

A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL, POETIC and ITCC

To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of nelarabine, etoposide and cyclophosphamide when given in combination to children with T-ALL and bone marrow relapse or T-LL.

A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients with Refractory Chronic
Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia

Primary Objective:To determine the efficacy of ponatinib in patients with CML in CP, AP or BP or with Ph+ ALL who either:are resistant or intolerant to either dasatinib or nilotinib,Or:have the T315I mutation.Secondary Objectives:* To further…

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB >= 66 years and very poor risk AML >= 18 years

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

An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDS4501A in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination with Rituximab in Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Primary goal is the evaluation of the safety and tolerability of MMMAE-anti-CD79b-conjugate administered every 3 weeks. The maximal tolerated dose and the dose-limiting toxicity are the important parameters. Based on these data, the dose of MMAE-…

A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

This phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib

Sequential FLAMSA chemotherapy and T cell depleted reduced intensity conditioning allogeneic stem cell transplantation (TCD FLAMSA-RIC alloSCT) in elderly acute myeloid leukemia and high risk myelodysplasia patients

• To assess feasibility and safety of a sequential treatment regime in which standard intensive chemotherapy (fludarabin-amsacrin-cytarabin) is directly followed by standard allogeneic stem cell transplantation (T cell depleted RIC alloSCT with…

A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

To evaluate LFS after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy

TRough vs AUC Monitoring of cyclosporine: A randomized comparison of adverse drug reactions in allogeneic stem cell recipients (TRAM-study)

The number and severity of adverse drug reactions (renal function, nausea and tremor) of cyclosporine using AUC targeted Therapeutic Drug Monitoring as compared to C0 targeted TDM.

A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia

Primary objective(s)• To evaluate the efficacy of blinatumomab to induce complete MRD responseKey secondary objective for patients with Ph-negative ALL • To evaluate the effect of blinatumomab on hematological relapseOther Secondary objectives• To…

Phase 1-2 Safety and Efficacy Study of DACOGEN in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia.

Primary ObjectivesPhase 1 portion:• to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2/day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2/day on Days 1-5 of a 28 day cycle. • to determine…

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).

Cardiovascular function after Stem cell Transplantation

To study whether CMR analysisdifferences in aortic stiffness and myocardial lipid accumulation between SCT recipients and healthy, age-matched controls

Comparative genomics and receptor signaling in MBL and CLL arising in siblings

This project aims to achieve advances in understanding CLL initiation and progression, and to identify novel targets for therapy of CLL, through a detailed genetic and immunological comparison of manifest CLL and MBL as the premalignant counterpart…

HAPLOIDENTICAL BONE MARROW TRANSPLANTATION FROM NK ALLOREACTIVE DONORS FOR PATIENTS WITH HIGH RISK ACUTE MYELOID LEUKEMIA - A PHASE 2 STUDY

The objective of this study is to provide evidence that it is likely that the application of haploidentical stem cell with NK cell alloreactive donors results in a low risk of AML recurrence and therefore in a higher probability of progression-free…