|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00763763 |
|
Date of registration:
|
25/07/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive
AFR07 |
|
Scientific 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 |
|
Date of first enrolment:
|
December 2004 |
|
Target sample size:
|
55 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00763763 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Philippe ROUSSELOT, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Assistance Publique - Hôpitaux de Paris |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Leukemia, Lymphocytic, Acute
|
|
Blast Crisis
|
|
Philadelphia Chromosome
|
|
Leukemia, Myeloid, Chronic
|
|
Intervention(s)
|
|
Drug: Dexamethasone
|
|
Drug: Vincristine
|
|
Drug: Interferon
|
|
Drug: Imatinib mesylate
|
|
Primary Outcome(s)
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|