- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00763763
Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive (AFR07)
October 4, 2011 updated by: Assistance Publique - Hôpitaux de Paris
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France, 75010
- Service Clinique des Maladies du Sang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
imatinib in combination with chemotherapy by vincristin and dexamethasone
|
imatinib 600 mg/day for 2 years
Other Names:
45 micrograms per week during 2 years
Other Names:
2 mg IV injection repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation
40 mg PO repeated weekly for 4 weeks as induction and then monthly for 4 months as consolidation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After 35 days or 56 days of induction
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Philippe ROUSSELOT, MD, Assistance Publique - Hôpitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
July 25, 2008
First Submitted That Met QC Criteria
September 30, 2008
First Posted (Estimate)
October 1, 2008
Study Record Updates
Last Update Posted (Estimate)
October 5, 2011
Last Update Submitted That Met QC Criteria
October 4, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Neoplastic Processes
- Cell Transformation, Neoplastic
- Carcinogenesis
- Chromosome Aberrations
- Translocation, Genetic
- Leukemia
- Leukemia, Myeloid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Blast Crisis
- Philadelphia Chromosome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Phytogenic
- Protein Kinase Inhibitors
- Dexamethasone
- Interferons
- Interferon-alpha
- Peginterferon alfa-2a
- Vincristine
- Imatinib Mesylate
Other Study ID Numbers
- P030425
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Blast Crisis
-
Nanfang Hospital of Southern Medical UniversityRecruitingChronic Myeloid Leukemia in Myeloid Blast Crisis | Chronic Myeloid Leukaemia Transformation | Chronic Myeloid Leukemia - Accelerated Phase | Chronic Myeloid Leukemia in Lymphoid Blast CrisisChina
-
University of JenaRecruitingChronic Myeloid Leukemia in Myeloid Blast CrisisGermany, Czechia, Russian Federation, Ukraine
-
University of CincinnatiNovartisWithdrawnA Study Evaluating the Effects of CLAG With Gleevec in Refractory or Relapsed Acute Myeloid LeukemiaAcute Myeloid Leukemia | Chronic Myeloid Leukemia, Blast CrisisUnited States
-
Versailles HospitalRecruitingCHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE | CHRONIC MYELOGENOUS LEUKAEMIA IN MYELOID BLAST CRISISFrance
-
Samus Therapeutics, Inc.WithdrawnAccelerated Phase MPN | Blast Phase MPN
-
Ulsan University HospitalThe Korean Society of Hematology CML working partyUnknownUntreated Adult Acute Myeloid Leukemia | Chronic Myeloid Leukemia in Myeloid Blast CrisisKorea, Republic of
-
University of FloridaFlorida Department of Health; Orca Biosystems, Inc.RecruitingAcute Myeloid Leukemia | Acute Lymphoid Leukemia | Acute Undifferentiated Leukemia | Chronic Myeloid Leukemia in Myeloid Blast Crisis | Chronic Myeloid Leukemia - Accelerated Phase | Mixed Phenotype Acute Leukemia | Chronic Myeloid Leukemia in Lymphoid Blast Crisis (Diagnosis)United States
-
John MascarenhasNational Cancer Institute (NCI); National Institutes of Health (NIH); Celgene... and other collaboratorsCompletedIDH2 Mutation | Accelerated/Blast-phase Myeloproliferative Neoplasm | Chronic-phase MyelofibrosisUnited States, Canada
-
Dana-Farber Cancer InstituteBrigham and Women's HospitalCompletedRefractory Acute Myeloid Leukemia | Myelodysplastic Syndrome RAEB-I or RAEB-II | Refractory CML Myeloid Blast CrisisUnited States
-
Novartis PharmaceuticalsTerminatedLeukemia, Myeloid, ChronicUnited States, Germany
Clinical Trials on Imatinib mesylate
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedChronic Myeloid LeukemiaChina
-
Institut BergoniéNovartisTerminatedLeukemia, Myeloid, Chronic-PhaseFrance
-
Scandinavian Sarcoma GroupCompleted
-
Sarit AssoulineNovartisRecruitingChronic Myeloid Leukemia | Chronic Myeloid Leukemia in Remission | Chronic Myeloid Leukemia, BCR/ABL-PositiveCanada
-
Novartis PharmaceuticalsCompletedProgressive Gastrointestinal Stromal TumorGermany
-
Novartis PharmaceuticalsCompletedLife Threatening Diseases
-
UNICANCERCompletedDesmoid TumorFrance
-
University Hospital, BordeauxNovartis; Ministry of Health, FranceCompletedScleroderma, Systemic | Scleroderma, LocalizedFrance
-
Maisonneuve-Rosemont HospitalHippocrate Research & DevelopmentUnknownGastrointestinal Stromal TumorsCanada