Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Trastuzumab

Criteria

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%