Status:
COMPLETED
Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Leukemia, Lymphocytic, Acute
Philadelphia Chromosome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients not previously exposed to imatinib and with resistant or refractory Ph+ ALL, lymphoid blast crisis chronic myelogenous leukaemia (LBC CML) or with de novo Ph+ ALL and aged over 55y were eligi...
Detailed Description
Gleevec™ is now considered as the gold standard treatment in chronic phase chronic myeloid leukemia (CML), for patients who are not candidate for an allogenic bone marrow transplantation. However, in ...
Eligibility Criteria
Inclusion
- Male or female subjects over 18 years,
- Poor prognosis BCR-ABL transcript-positive acute lymphoblastic leukemia (refractory or relapsing Ph+ ALL, BP lymphoid CML, BP lymphoid CML in relapse)
Exclusion
- Pregnant female,
- Blastic involvement of the CNS,
- Participation in an investigational agent trial within 4 weeks,
- High dose therapy within 4 weeks,
- Gleevec administration within 3 months,
- Transaminases grade 3 or 4 elevation.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00763763
Start Date
December 1 2004
End Date
January 1 2010
Last Update
October 5 2011
Active Locations (1)
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1
Service Clinique des Maladies du Sang
Paris, Paris, France, 75010