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Distribution of NIlotinib in semen in men treated for chronic Myeloid leukaemiA

This study is designed to determine the level of nilotinib detectable in seminal fluid of men treated with this tyrosine kinase inhibitor and in order to form an advise on the use of physical barriers like, condoms, to protect sexual partners from…

An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…

Evaluation of the intracellular pharmacokinetics of decitabine in patients with leukemia or myelodysplasia

The present study will be focused on exploring the intracellular pharmacokinetics of decitabine

PERSISTENCE OF MAJOR MOLECULAR REMISSION IN CHRONIC MYELOID
LEUKEMIA AFTER a second stop of TKI TREATMENT in patients who failed an
initial stop attempt : a multicenter prospective trial

Assessment of treatment-free remission (persistence of MMR) after second attempt of TKI discontinuation in patients who failed a relapsed in the EURO-SKI study or under EURO-SKI like conditions. Patients must have received at least three years of…

A phase I/II trial towards the safety and efficacy of preemptive vaccination with PD-L silenced, minor histocompatibility antigen UTA2-1 peptide-loaded Dendritic Cells after Allogeneic Stem Cell Transplantation

- To evaluate the toxicity and feasibility of a preemptive minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DCvaccination.- To evaluate the effect of a minor H ag UTA2-1 peptide-loaded, PD-L silenced donor DC vaccination on the immunestatus of…

Long-term follow-up of patients previously treated with autologous T cells genetically modified with retroviral vectors.

Primary Objective:- Long-term safetySecondary Objective:- Survival- Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression- Chimeric antigen receptor (CAR) transgene persistence- Replication competent…

A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of 14C-Guadecitabine in Subjects with AML, MDS, or Solid Tumors

This study will provide an estimate of basic PK parameters for guadecitabine, an assessment of the routes and rates of elimination of radioactivity, and identification of metabolites and metabolic pathways.

A phase I, open label, multicenter, dose-escalation study of oral HDM201 in adult patients with advanced solid and hematological tumors characterized by wild-type TP53

Primary objective To determine the MTD and/or to identify the RDE of HDM201 in one or more of the pre-defined regimensSecondary objectives * To characterize the safety and tolerability of HDM201* To characterize the pharmacokinetic (PK) properties…