Back to resultsSafety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients
Primary Purpose
Chronic Myeloid Leukemia
Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Imatinib mesylate 600 mg
Cytarabine
Daunorubicine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring CML, Acute Phase, Imatinib mesylate, Cytarabine, Daunorubicine
Eligibility Criteria
Inclusion Criteria: CML Ph+ (assessed by cytogenetic or FISH) Acute phase with ≥ 20% bone marrow blasts (M0 to M6 , excluding M3) Age ≥ 18 year at inclusion PS grade 0 to 2 (ECOG) Adequate and organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln. Informed consent signed up Exclusion Criteria: active malignancy other than CML or non-melanoma cancer of the skin current treatment with another investigational agent patients with grade 3/4 cardiac disease or any other serious concurrent medical condition. patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study. patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements patients with performans status 3-4
Sites / Locations
- University Hospital
Outcomes
Primary Outcome Measures
To assess the tolerability and the effectiveness of imatinib in combination with daunorubicine and cytarabine and to determine the recommended dose of daunorubicine to be associated with cytarabine
Secondary Outcome Measures
- To evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
- To evaluate duration of responses and failure to respond
Full Information
NCT ID
NCT00219765
First Posted
September 13, 2005
Last Updated
November 25, 2005
Sponsor
Poitiers University Hospital
Collaborators
Ministry of Health, France, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00219765
Brief Title
Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients
Official Title
Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Poitiers University Hospital
Collaborators
Ministry of Health, France, Novartis
4. Oversight
5. Study Description
Brief Summary
The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.
Detailed Description
Study design Imatinib: starting at day -3: 600mg/day; continuous administration In combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4 levels
level 1: 0
level 2: 15mg/m² ; 3 days
level 3: 30mg/m² ; 3 days
level 4: 45mg/m² ; 3 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
CML, Acute Phase, Imatinib mesylate, Cytarabine, Daunorubicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Imatinib mesylate 600 mg
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Type
Drug
Intervention Name(s)
Daunorubicine
Primary Outcome Measure Information:
Title
To assess the tolerability and the effectiveness of imatinib in combination with daunorubicine and cytarabine and to determine the recommended dose of daunorubicine to be associated with cytarabine
Secondary Outcome Measure Information:
Title
- To evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.
Title
- To evaluate duration of responses and failure to respond
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CML Ph+ (assessed by cytogenetic or FISH)
Acute phase with ≥ 20% bone marrow blasts (M0 to M6 , excluding M3)
Age ≥ 18 year at inclusion
PS grade 0 to 2 (ECOG)
Adequate and organ function, defined as the following: total bilirubin <1.5x uln, sgpt <3x uln, creatinine <1.5x uln.
Informed consent signed up
Exclusion Criteria:
active malignancy other than CML or non-melanoma cancer of the skin
current treatment with another investigational agent
patients with grade 3/4 cardiac disease or any other serious concurrent medical condition.
patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements patients with performans status 3-4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François GUILHOT, MD
Organizational Affiliation
Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22987312
Citation
Rousselot P, Cony-Makhoul P, Nicolini F, Mahon FX, Berthou C, Rea D, Reiffers J, Bornand A, Saint-Jean O, Guilhot J, Guilhot F; French Intergroup For Chronic Myelogenous Leukemia (Fi-LMC). Long-term safety and efficacy of imatinib mesylate (Gleevec(R)) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study. Am J Hematol. 2013 Jan;88(1):1-4. doi: 10.1002/ajh.23330. Epub 2012 Sep 17.
Results Reference
derived
PubMed Identifier
21145590
Citation
Deau B, Nicolini FE, Guilhot J, Huguet F, Guerci A, Legros L, Pautas C, Berthou C, Guyotat D, Cony-Makhoul P, Gardembas M, Michallet M, Hayette S, Cayuela JM, Weiss IR, Rea D, Castaigne S, Mahon FX, Guilhot F, Rousselot P. The addition of daunorubicin to imatinib mesylate in combination with cytarabine improves the response rate and the survival of patients with myeloid blast crisis chronic myelogenous leukemia (AFR01 study). Leuk Res. 2011 Jun;35(6):777-82. doi: 10.1016/j.leukres.2010.11.004. Epub 2010 Dec 10.
Results Reference
derived
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Safety and Efficacy of Imatinib in Combination With High Dose Chemotherapy for Acute Phase Chronic Myelogenous Patients
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