Relapsed/Refractory Leukemia
Conditions
Keywords
relapsed/refractory, HER2, positive, B-ALL, trastuzumab
Brief summary
This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.
Interventions
Administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or until progression
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Trastuzumab efficiency concerning transfusional needs | — |
| Overall survival | — |
| Leukemia free survival | — |
| cytogenetic response rate | — |
| Trastuzumab tolerance profile | — |
Countries
France
Outcome results
None listed