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

October 4, 2013 updated by: Nantes University Hospital

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Clermont-Ferrand University Hospital
      • Créteil, France, 94000
        • MONDOR Hospital
      • Grenoble, France, 38043
        • Grenoble Hospital
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Nantes, France, 44093
        • CHU
      • Paris, France, 75010
        • St Louis Hospital
      • Rennes, France, 35033
        • Rennes University Hospital
      • Strasbourg, France, 67098
        • Strasbourg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 7, 2013

Last Update Submitted That Met QC Criteria

October 4, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD04/2-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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