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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00724360
Recruitment Status : Terminated (Difficulties of recruitment)
First Posted : July 29, 2008
Last Update Posted : October 7, 2013
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Leukemia Drug: Herceptin (trastuzumab) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.
Study Start Date : November 2006
Primary Completion Date : July 2011
Study Completion Date : November 2011

Intervention Details:
    Drug: Herceptin (trastuzumab)
    Administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or until progression

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

Secondary Outcome Measures :
  1. Trastuzumab efficiency concerning transfusional needs
  2. Overall survival
  3. Leukemia free survival
  4. cytogenetic response rate
  5. Trastuzumab tolerance profile

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00724360

Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63003
Mondor Hospital
Créteil, France, 94000
Grenoble Hospital
Grenoble, France, 38043
Institut Paoli Calmettes
Marseille, France, 13273
Nantes, France, 44093
St Louis Hospital
Paris, France, 75010
Rennes University Hospital
Rennes, France, 35033
Strasbourg University Hospital
Strasbourg, France, 67098
Sponsors and Collaborators
Nantes University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nantes University Hospital Identifier: NCT00724360     History of Changes
Other Study ID Numbers: BRD04/2-T
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: October 7, 2013
Last Verified: October 2013

Keywords provided by Nantes University Hospital:

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents