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Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive (AFR07)

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ClinicalTrials.gov Identifier: NCT00763763
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : October 5, 2011
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 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.

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Acute Philadelphia Chromosome Blast Crisis Leukemia, Myeloid, Chronic Drug: Imatinib mesylate Drug: Interferon Drug: Vincristine Drug: Dexamethasone Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : January 2010


Arm Intervention/treatment
Experimental: 1
imatinib in combination with chemotherapy by vincristin and dexamethasone
Drug: Imatinib mesylate
imatinib 600 mg/day for 2 years
Other Name: Interferon, Pegasys

Drug: Interferon
45 micrograms per week during 2 years
Other Name: Pegasys

Drug: Vincristine
2 mg IV injection repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation

Drug: Dexamethasone
40 mg PO repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation




Primary Outcome Measures :
  1. To determine the rate of hematological response induced by Gleevec™ combined with vincristine and dexamethasone [ Time Frame: After 35 days or 56 days of induction ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763763


Locations
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France
Service Clinique des Maladies du Sang
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Philippe ROUSSELOT, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00763763    
Other Study ID Numbers: P030425
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Imatinib mesylate
Combination therapy
Leukemia, Lymphocytic, Acute
Philadelphia Chromosome
Blast Crisis
Leukemia, Myeloid, Chronic
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Blast Crisis
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferons
Peginterferon alfa-2a
Interferon-alpha
Dexamethasone
Vincristine
Imatinib Mesylate
Anti-Inflammatory Agents
Antiemetics