Phase II efficacy and safety study of Dasatinib in Patients with Chronic and Accelerated Phase Chronic Myeloid Leukaemia Relapsing after Allogeneic Blood or Bone Marrow Transplantation - CML DASATINIB

EBMT (European group for Blood and Marrow Transplantation)0 sites50 target enrollmentAugust 20, 2009

Overview

No summary available.

Registry

who.int

Start Date

August 20, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

EBMT (European group for Blood and Marrow Transplantation)

•1\) Male or female patients minimum 18 years of age
•2\) Diagnosed with BCR\-ABL (\+) Chronic Myeloid Leukemia (they can be Philadelphia chromosome positive or negative)
•3\) Prior therapy including imatinib
•4\) Patients transplanted from an HLA\-identical sibling or an HLA\-matched unrelated donor.
•5\) Patients transplanted in first chronic phase or accelerated phase.
•6\) Patients with untreated relapse of BCR\-ABL (\+) CML after allogeneic transplantation and entered within 6 weeks of the first detection of relapse.
•7\) Molecular, cytogenetic or haematological relapse in chronic or accelerated phase.
•8\) Written informed consent.
•9\) Absence of serious concomitant illness.
•10\) Negative pregnancy test for women of child bearing age

•1\) Patients relapsing in blast crisis.
•2\) Patients transplanted after blastic transformation of CML.
•3\) Patients receiving any therapy for relapse other than withdrawal of immunosuppression (DLI is not permitted).
•4\) Patients treated with other investigational agents during the previous 30 days (list of prohibited therapies can be found in section 8\.6\.1\)
•5\) Patients previously treated with Dasatinib.
•6\) Absence of written informed consent.
•7\)Patients incapable of giving consent personally.
•8\) Presence of serious concomitant disease.
•9\) History of a significant bleeding disorder unrelated to CML.
•10\) Pregnancy or lactation status positive.