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Factors influencing the outcome of nilotinib treatment in patients with chronic myeloid leukemia in daily practice

The primary study objective is to assess whether CML patients who respond to treatment with nilotinib (MMR within 12 months of treatment) differ from the non-responders in terms of adherence. Secondary objective is to evaluate whether responders and…

A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the
efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with
chronic lymphocytic leukemia following first-line therapy

To compare the efficacy and safety of lenalidomide versus placebo maintenance therapy (standard care).

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…

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.

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…

Treatment guided by detection of Minimal Residual Disease after allogeneic stem cell transplantation in Acute Myeloid Leukaemia

To decrease the cumulative incidence of (hematological) relapse

A Phase II, single arm, open label study of treatment-free remission in chronic myeloid leukemia (CML) chronic phase (CP) patients after achieving sustained MR4.5 on Nilotinib

The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…

A PHASE 1, OPEN-LABEL STUDY OF THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-LABELED IPI-145 AND THE ABSOLUTE BIOAVAILABILITY OF IPI-145 IN HEALTHY SUBJECTS

Primary: To evaluate the absorption, distribution, metabolism and excretion of IPI-145 following a single oral dose of 14C0IPI-145.To determine the absolute bioavailability of IPI-145 following a single oral dose of IPI-145 and an intravenous…

A Single arm, multicenter, nilotinib treatment-free remission study in patients with BCR-ABL1 positive Chronic Myelogenous Leukemia in chronic phase who have achieved durable minimal residual disease (MRD) status on first line nilotinib treatment

The main purpose of this study is to determine the rate of treatment-free molecular remission (MMR=MR3.0) after 48 weeks following start of the TFR phase. The study further seeks to provide evidence that suspending nilotinib therapy in these…

A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Relapsed/Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic Malignancies

Primary objectives:*To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of EPZ-5676 when administered as a 21-day or 28 day CIV infusion to patients with refractory hematologic malignancies.*To assess the safety and…

A phase II, single arm, multicenter study of nilotinib in combination with pegylated interferon *2b in patients with suboptimal molecular response or stable detectable molecular residual disease after at least two years of imatinib treatment (NordDutchCML009)

To assess the effect of switching CML patients, who have been treated with imatinib *2 years and who have stable detectable molecular residual disease above 0.01% (IS), to the combination of Nilotinib and PegIFN, in terms of the proportion of…

A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients * 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy

To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low-dose cytarabine in patients * 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction…

A phase I/II feasibility study of panobinostat alone and the combination of panobinostat and decitabine prior to donor lymphocyte infusion in recipients of allogeneic stem cell transplantation with poor and very poor risk AML

Primary objective:Part I- To asses the feasibility of addition of post-transplant panobinostat combined with decitabine to a regimen of T-cell replete RIC alloHSCT in patients with very poor risk AML/RAEB, and select the dose level for the phase II…

Protocol for treatment of children and adolescents with acute myeloid leukemia 0-18 years

This study has been transitioned to CTIS with ID 2024-518254-16-00 check the CTIS register for the current data. The primary aim of the NOPHO-DBH AML 2012 study is to improve EFS and OS in children with AML. To improve outcome, an intensified…

HOVON 132 AML / SAKK 30/13, Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score >4.5)

See above

A MULTICENTER, PHASE III, OPEN-LABEL, RANDOMIZED STUDY IN RELAPSED/REFRACTORY PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TO EVALUATE THE BENEFIT OF GDC-0199 (ABT-199) PLUS RITUXIMAB COMPARED WITH BENDAMUSTINE PLUS RITUXIMAB

Efficacy ObjectivesThe primary efficacy objective:• To evaluate the efficacy of GDC-0199 and rituximab (GDC-0199+R) compared with bendamustine and rituximab (BR) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) as measured…

Skeletal complications of prophylactic ciprofloxacin in the treatment of pediatric ALL

To determine the musculoskeletal safety of standard prophylactic treatment with ciprofloxacin and co-administered glucocorticoids in pediatric patients with ALL.

AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008

The objectives of the current study are:1. To allow long term bosutinib treatment in patients with chronic or advanced phases of Ph+ CML who received bosutinib in a previous Pfizer sponsored CML study (i.e., studies B1871006 and B1871008) and who…

A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib

Primary objectives:* To assess efficacy of nilotinib in pediatric patients with Ph+ CML CPresistant or intolerant to either imatinib or dasatinib.* To assess efficacy of nilotinib in pediatric patients with Ph+ CML APresistant or intolerant to…