Study to Evaluate Efficacy and Safety of Glivec® in Combination With Vincristine and Dexamethasone in Patients With Lymphoid Blast Crisis CML or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia in Relapse or Refractory
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 advanced phase CML and Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph+ ALL), development of resistance to imatinib has become the
central issue concerning the use of imatinib as a monotherapeutic agent. The response rate
(complete hematological remission) at the dose of 600 mg/d in poor prognosis lymphoid blast
phase CML and Ph+ ALL was about 20% and median time to disease progression was only 2.2
months. In VITRO studies have addressed the question of combined therapy with imatinib. A
synergistic or additive activity has been demonstrated with vincristine and dexamethasone,
two major drugs for the treatment of acute lymphoblastic leukemia (ALL). On going clinical
studies are also testing Gleevec™ in association with daunorubicin and cytarabine (standard
dose) in CML in myeloid blast phase (CST571AFR01) or with MITHOXANTROME and cytarabine
(intermediate dose) as a consolidation regiment in Ph+ ALL in first CR (CSTI571AFR03). The
safety of the combined therapy was excellent in the two studies. Therefore, we propose to
initiate a study to assess the efficacy and the safety of Gleevec™ combined with vincristine
and dexamethasone in patients with relapsed or refractory Philadelphia chromosome-positive
acute lymphoblastic leukemias
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the rate of hematological response induced by Gleevec™ combined with vincristine and dexamethasone
After 35 days or 56 days of induction
No
Philippe ROUSSELOT, MD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health
P030425
NCT00763763
December 2004
January 2010
Name | Location |
---|