Study Stopped
Difficulties of recruitment
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.
1 other identifier
interventional
15
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2006
Longer than P75 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedOctober 7, 2013
October 1, 2013
4.7 years
July 25, 2008
October 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Secondary Outcomes (5)
Trastuzumab efficiency concerning transfusional needs
Overall survival
Leukemia free survival
cytogenetic response rate
Trastuzumab tolerance profile
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous treatment by trastuzumab
- FEVG \< 50%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63003, France
Mondor Hospital
Créteil, 94000, France
Grenoble Hospital
Grenoble, 38043, France
Institut Paoli Calmettes
Marseille, 13273, France
CHU
Nantes, 44093, France
St Louis Hospital
Paris, 75010, France
Rennes University Hospital
Rennes, 35033, France
Strasbourg University Hospital
Strasbourg, 67098, France
Related Publications (1)
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. doi: 10.1182/blood-2011-11-390781. Epub 2012 Jan 20.
PMID: 22267607DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 29, 2008
Study Start
November 1, 2006
Primary Completion
July 1, 2011
Study Completion
November 1, 2011
Last Updated
October 7, 2013
Record last verified: 2013-10