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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

July 25, 2008
June 1, 2010
November 2006
Not Provided
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Same as current
Complete list of historical versions of study NCT00724360 on ClinicalTrials.gov Archive Site
  • Trastuzumab efficiency concerning transfusional needs
  • Overall survival
  • Leukemia free survival
  • cytogenetic response rate
  • Trastuzumab tolerance profile
  • Safety
  • Overall survival
  • Leukemia free survival
Not Provided
Not Provided
 
Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsed/Refractory Leukemia
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
Not Provided
Chevallier P, Robillard N, Charbonnier A, Raffoux E, Maury S, Carras S, Chabrot C, Fohrer C, Bernard M, Blade JS, Etienne A, Talmant P, Delaunay J, Guillaume T, Mohty M, Bene MC, Ifrah N, Dombret H. Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase 2 GRAALL study. Blood. 2012 Mar 15;119(11):2474-7. Epub 2012 Jan 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
Not Provided
Not Provided

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%
Both
18 Years and older
No
Contact: Patrice Chevallier, MD (33) 2 40 08 39 94
France
 
NCT00724360
BRD04/2-T
Not Provided
Pr Jean-Luc Harousseau, CHU de Nantes
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP