Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia, Lymphocytic, Acute; Philadelphia Chromosome; Blast Crisis; Leukemia, Myeloid, Chronic
Intervention: Imatinib mesylate (Drug); Interferon (Drug); Vincristine (Drug); Dexamethasone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s): Philippe ROUSSELOT, MD, Principal Investigator, Affiliation: Assistance Publique - HĂ´pitaux de Paris
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 eligible in the study. The DIV regimen consisted in one IV injection of
vincristine 2 mg combined with 2 days of dexamethasone 40 mg PO repeated weekly for 4 weeks
as induction and then monthly for 4 months as consolidation. Imatinib was administered at
800 mg per day during the induction period and at 600 mg/d continuously during
consolidation. Patients in CR not eligible for HSCT were allocated to maintenance therapy
consisting in weekly SC injection of Pegasys 45 µg and continuous administration of imatinib
400 mg per day for 2 years.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To determine the rate of hematological response induced by Gleevec™ combined with vincristine and dexamethasone
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 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Service Clinique des Maladies du Sang, Paris 75010, France
Additional Information
Starting date: December 2004
Last updated: October 4, 2011
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