A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Relapsed/Refractory Leukemia
Both
Relapsed/Refractory Leukemia
Trial Information
A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.
Inclusion Criteria:
- age > 18 years
- B-ALL in relapse
- refractory B-ALL-performance status of 0-2 on the Eastern Cooperative Oncology Group
scale
- adequate hepatic and renal functions (AST or ALT <= 5 times the upper limit of normal
creatinine < 2 times the upper limit of normal)
- > 20% blasts in bone marrow,
- > 30% of bone marrow blast population HER2 positive as assessed by immunophenotyping
Exclusion Criteria:
- Previous treatment by trastuzumab
- FEVG < 50%
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
BRD04/2-T
NCT ID:
NCT00724360
Start Date:
November 2006
Completion Date:
Related Keywords:
- Relapsed/Refractory Leukemia
- relapsed/refractory
- HER2
- positive
- B-ALL
- trastuzumab
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|
