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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphocytic, Acute, Philadelphia Chromosome, Blast Crisis, Leukemia, Myeloid, Chronic

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the rate of hematological response induced by Gleevec™ combined with vincristine and dexamethasone

Outcome Time Frame:

After 35 days or 56 days of induction

Safety Issue:

No

Principal Investigator

Philippe ROUSSELOT, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P030425

NCT ID:

NCT00763763

Start Date:

December 2004

Completion Date:

January 2010

Related Keywords:

  • Leukemia, Lymphocytic, Acute
  • Philadelphia Chromosome
  • Blast Crisis
  • Leukemia, Myeloid, Chronic
  • Imatinib mesylate
  • Combination therapy
  • Leukemia, Lymphocytic, Acute
  • Philadelphia Chromosome
  • Blast Crisis
  • Leukemia, Myeloid, Chronic
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

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