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Randomized study with a run-in feasibility phase to assess the added value of Clofarabine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or myelodysplasia (MDS) (RAEB with IPSS â*¥ 1.5)

Primary objectivesFor part A of the study: -To determine the feasibility of Clofarabine when given at three possible dose levels together with standard induction cycles I and II in patients with AML/ RAEB with IPSS>=1.5 in a prospective…

Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.

Primary objectives:1.The fesibility of clofarabine when given together with standard prephase chemotehrapy in a prospective comparison to standard prephase chemotherapy (prednison). 2.To evaluate the effect of clofarabin when combined with prephase…

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…

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

Pilot-study: Dexamethasone and function of the HPA axis in children after treatment for Acute Lymphoblastic Leukemia; Relation to sleep

The objectives of this pilot study are to explore differences in sleep and fatigue, and the relation with the function of the HPA axis, between survivors of childhood ALL and healthy controls.

Bortezomib (Velcade®): A feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia

To determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL.

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral tosedostat to standard induction therapy in AML and RAEB >= 66 years and very poor risk AML >= 18 years.;A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML

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

A phase I/II, open-label, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of twice daily oral midostaurin and to evaluate the preliminary clinical and pharmacodynamic response in pediatric patients with relapsed or refractory leukemia

This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability and pharmacokinetics of midostaurin in children <18 years of age and >= 3 months who have relapsed or refractory leukemias that may benefit…

Randomized maintenance therapy with Azacitidine (Vidaza) in older patients (>=
60 years of age) with acute myeloid leukemia (AML) and refractory anemia with excess of blasts (RAEB, RAEB-t)

- To assess, in a randomized study the value of Azacitidine as post remission therapy (in comparison to observation) in elderly patients with AML, RAEB or RAEB-t with respect to the disease free survival.- In addition, post remission Azacitidine…

Is early revaccination after ALL therapy feasible ?
Evaluation of loss of antibodies and responsiveness to (re-)vaccination in children after treatment for acute lymphocytic leukemia.

To determine effect of early (re) vaccinations after the current intensive chemotherapy for ALL. We will determine if there is a difference in respons to conjugated (T cell dependent) and polysaccharide (T cell independent) vaccines. This may result…

Efficacy and safety of recombinant asparaginase in infants ( < 1 year) with previously untreated acute lymphoblastic leukemia, a phase II clinical trial

This non-controlled multicentric phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase for first-line treatment of infants (&lt; 1 year of age at…

A Phase II Study of Dasatinib Therapy in Children and Adolescents with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or with Ph+ Leukaemias Resistant or Intolerant to Imatinib

The main objective of this study is to estimate the rate of response to dasatinib in children and adolescents with certain types of Ph+ leukaemia either whose disease is resistant to, intolerant to or relapsed after previous imatinib therapy or are…

A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndrome

Primary objective- To evaluate the efficacy of lenalidomide (RevlimidTM) in low/int-1 risk MDS with or without a treatment with Epo (NeoRecormonTM)/G-CSF (NeupogenTM) in terms of hematological improvement (HI) as defined by the modified response…