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

This study has been terminated.
(Difficulties of recruitment)
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00724360
First received: July 25, 2008
Last updated: October 4, 2013
Last verified: October 2013
  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:


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

Enrollment: 15
Study Start Date: November 2006
Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724360

Locations
France
Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63003
Mondor Hospital
Créteil, France, 94000
Grenoble Hospital
Grenoble, France, 38043
Institut Paoli Calmettes
Marseille, France, 13273
CHU
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
  More Information

No publications provided by Nantes University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00724360     History of Changes
Other Study ID Numbers: BRD04/2-T
Study First Received: July 25, 2008
Last Updated: October 4, 2013
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014