Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
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ClinicalTrials.gov Identifier: NCT00724360
Recruitment Status :
(Difficulties of recruitment)
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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