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| Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00763763 |
Purpose
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 dexaméthasone 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 | Intervention | Phase |
|---|---|---|
|
Leukemia, Lymphocytic, Acute Philadelphia Chromosome Blast Crisis Leukemia, Myeloid, Chronic |
Drug: Imatinib mesylate Drug: Interferon Drug: Vincristine Drug: Dexamethasone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 55 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | January 2010 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
imatinib in combination with chemotherapy
|
Drug: Imatinib mesylate
imatinib 600 mg/day for 2 years
Drug: Interferon
45 micrograms per week during 2 years
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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Service Clinique des Maladies du Sang | |
| Paris, France, 75010 | |
| Principal Investigator: | Philippe ROUSSELOT, MD | Assistance Publique - Hôpitaux de Paris |
More Information
| Responsible Party: | Department Clinical Research of Developpement ( Aurélie Guimfack ) |
| Study ID Numbers: | P030425 |
| Study First Received: | July 25, 2008 |
| Last Updated: | September 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00763763 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Imatinib mesylate Combination therapy Leukemia, Lymphocytic, Acute |
Philadelphia Chromosome Blast Crisis Leukemia, Myeloid, Chronic |
|
Anti-Inflammatory Agents Philadelphia Chromosome Dexamethasone Anti-Infective Agents Blast Crisis Leukemia, Lymphoid Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Protein Kinase Inhibitors Hormones Leukemia Lymphoma Acute Lymphoblastic Leukemia Dexamethasone acetate |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hematologic Diseases Interferons Myeloproliferative Disorders Vincristine Antimitotic Agents Leukemia, Myeloid Antiviral Agents Glucocorticoids Imatinib Lymphatic Diseases Tubulin Modulators Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
|
Dexamethasone Philadelphia Chromosome Anti-Inflammatory Agents Blast Crisis Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Protein Kinase Inhibitors Pathologic Processes Therapeutic Uses Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Immune System Diseases Antineoplastic Agents, Hormonal Hematologic Diseases Myeloproliferative Disorders Vincristine Leukemia, Myeloid Glucocorticoids Imatinib Neoplasms Antineoplastic Agents, Phytogenic Cell Transformation, Neoplastic Leukemia, Lymphoid Antineoplastic Agents Leukemia Neoplastic Processes |
