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Clinical Trials/NCT00724360
NCT00724360TerminatedPhase 2

A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.

Nantes University Hospital8 sites in 1 country15 target enrollmentStarted: November 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
15
Locations
8
Primary Endpoint
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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%

Outcomes

Primary Outcomes

Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)

Secondary Outcomes

  • Trastuzumab efficiency concerning transfusional needs
  • Overall survival
  • Leukemia free survival
  • cytogenetic response rate
  • Trastuzumab tolerance profile

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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