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

Nantes University Hospital (NUH)

Status and phase: Terminated; Phase 2

Conditions: Relapsed/Refractory Leukemia

Treatments: Drug: Herceptin (trastuzumab)

Study type: Interventional

Funder types: Other

Identifiers

NCT00724360

BRD04/2-T

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)