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

Primary Purpose

Relapsed/Refractory Leukemia

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Herceptin (trastuzumab)
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Leukemia focused on measuring relapsed/refractory, HER2, positive, B-ALL, trastuzumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Clermont-Ferrand University Hospital
  • Mondor Hospital
  • Grenoble Hospital
  • Institut Paoli Calmettes
  • CHU
  • St Louis Hospital
  • Rennes University Hospital
  • Strasbourg University Hospital

Outcomes

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

Full Information

First Posted
July 25, 2008
Last Updated
October 4, 2013
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00724360
Brief Title
Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Difficulties of recruitment
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Leukemia
Keywords
relapsed/refractory, HER2, positive, B-ALL, trastuzumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Herceptin (trastuzumab)
Intervention Description
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 Measure Information:
Title
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Secondary Outcome Measure Information:
Title
Trastuzumab efficiency concerning transfusional needs
Title
Overall survival
Title
Leukemia free survival
Title
cytogenetic response rate
Title
Trastuzumab tolerance profile

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Facility Information:
Facility Name
Clermont-Ferrand University Hospital
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Mondor Hospital
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Grenoble Hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CHU
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
St Louis Hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Strasbourg University Hospital
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22267607
Citation
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.
Results Reference
derived

Learn more about this trial

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

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