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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00724360
First received: July 25, 2008
Last updated: June 1, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention Phase
Relapsed/Refractory Leukemia
 Drug: Herceptin (trastuzumab)
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

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

Secondary Outcome Measures:
  • Trastuzumab efficiency concerning transfusional needs
  • Overall survival
  • Leukemia free survival
  • cytogenetic response rate
  • Trastuzumab tolerance profile

Estimated Enrollment: 25
Study Start Date: November 2006
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00724360

Contacts
Contact: Patrice Chevallier, MD (33) 2 40 08 39 94

Locations
France
CHU Recruiting
Nantes, France, 44093
Contact: Patrice Chevallier     (33) 2 40 08 39 94        
Sub-Investigator: Patrice CHEVALLIER, MD            
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pr Jean-Luc Harousseau, CHU de Nantes
ClinicalTrials.gov Identifier: NCT00724360     History of Changes
Other Study ID Numbers: BRD04/2-T
Study First Received: July 25, 2008
Last Updated: June 1, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
relapsed/refractory
HER2
positive
B-ALL
trastuzumab

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

ClinicalTrials.gov processed this record on June 17, 2013