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A Phase II study of Selinexor (KPT-330) combined with bortezomib and dexamethasone (SVd) for induction and consolidation for patients with progressive or refractory Multiple Myeloma.

Part I: Evaluate the safety and tolerability of selinexor at 3 different dose levels in combination with bortezomib/dexamethasone & determine recommended dose level (RDL) of selinexor for Part IIPart II: Evaluate the efficacy of the…

Phase Ib/II study of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer

The primary objective of the phase I part of the study is to determine the recommended phase II dose of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer. The secondary objectives the phase I…

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…

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…

LUMC 2014-01 - Transfer of Streptamer selected multiantigen-specific T cells to prevent infections and relapse after allogeneic Stem Cell Transplantation - a phase I/II study

• To evaluate the efficacy of the transfer of multiantigen specific T cells by measuring the appearance or expansion (if antigenic specific donor derived cells are already present in the circulation of the patient at time of infusion) of antigen…

European phase-II clinical trial evaluating efficacy of low dose rhIL-2 in patients with recently diagnosed type 1 diabetes

Primary objective1. To evaluate efficacy of ILT-101 for the preservation of residual pancreatic β cells function2. To select the optimal regimen of administration of ILT-101.Secondary objectivesTo assess:1. Tregs expansion after an induction period…

A Randomized Phase 2 Study of AP26113 in Patients with ALK-positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated with Crizotinib

The primary objective of the study is to determine the efficacy of AP26113, as evidenced by objective response rate, in patients with ALK positive locally advanced or metastatic NSCLC whose disease has progressed on therapy with crizotinib.

A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma - BEACON-Neuroblastoma Trial

This study has been transitioned to CTIS with ID 2024-518931-12-00 check the CTIS register for the current data. Primary:- To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide or irinotecan-temozolomide or topotecan-…

Phase II, Open-label, Study in Subjects with BRAF V600E - Mutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib (BRF117019)

Primary: efficacy of dabrafenib and trametinib combination therapy compared to placebo with respect to overall response rate in subjects with rare BRAF V600E mutated solid tumors or hematologic malignancies.Secondary: duration of response,…

[18-F]-Fluordihydrotestosterone PET and [18F]-prostate specific membrane antigen in metastasized castrate resistant prostate cancer

The objectives of this trial are:1. To define the performance characteristics of FDHT PET in patients with metastasized castrate resistant prostate cancer(mCRPC).(a) To demonstrate the kinetics of displacement of the tracer off of the androgen…

Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients

The aim of this study is to improve the outcome of both younger and elderly primary plasma cell leukemia patients(pPCL) by using next generation novel agents and in case of younger patients also the tandem of auto-SCT and allo-SCT.

HOVON 124 WM study: A prospective phase I/II trial of the combination of ixazomib citrate, rituximab and dexamethasone in patients with relapsed or progressive Waldenström's macroglobulinemia.

Currently, there are no curative treatment options for patients with Waldenstrom*s macroglobulinemia (WM) and there is no consensus on standard first line or relapse treatment. The proteasome inhibitor bortezomib has shown efficacy in WM, but is…

A Phase 2, Multicenter, Multinational, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of ORGN001 (formerly ALXN1101) in Pediatric Patients with Molybdenum Cofactor Deficiency (MoCD) Type A Currently Treated with Recombinant Escherichia coli-derived Cyclic Pyranopterin Monophosphate (rcPMP)

Primary:• To evaluate the safety of ORGN001 (formerly ALXN1101) over the first 6 months of treatmentSecondary:• To characterize the pharmacokinetics (PK) of increasing doses of ORGN001 (formerly ALXN1101) • To evaluate the effect of ORGN001 (…