Status:
COMPLETED
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
Lead Sponsor:
Poitiers University Hospital
Collaborating Sponsors:
Novartis
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplanta...
Detailed Description
Patients will received Imatinib at a dose of 400mg daily. The tolerability of Imatinib given at a daily dose of 400mg will be assessed. The hematologic, cytogenetic and molecular responses will be eva...
Eligibility Criteria
Inclusion
- CML Ph+ (assessed by cytogenetic or FISH)
- Age ≥ 18 year at inclusion
- PS grade 0 to 2 (ECOG)
- previous allogeneic stem cell transplantation
- molecular, cytogenetic or haematological relapse in chronic phase after transplantation
- Immune therapy for graft versus host disease stopped within 2 months from inclusion
- Adequate and organ function, defined as the following: total bilirubin \<3x uln, sgpt \<3x uln, creatinine \<2x uln.
- informed consent sign up
Exclusion
- Age less than 18 y
- accelerated or blastic phase
- previous therapy with imatinib
- active malignancy other than CML or non-melanoma cancer of the skin
- current treatment with another investigational agent
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00219726
Start Date
May 1 2002
End Date
July 1 2007
Last Update
August 29 2012
Active Locations (1)
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1
University Hospital
Poitiers, France, 86021