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

Relapsed/Refractory Leukemia Clinical Trial

Official title:

A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00724360
• Other study ID #: BRD04/2-T
• Status: Terminated
• Phase: Phase 2
• First received: July 25, 2008
• Last updated: October 4, 2013
• Start date: November 2006
• Est. completion date: November 2011

Study information

• Verified date: October 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Relapsed/Refractory Leukemia

Intervention

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

Locations

Country	Name	City	State
France	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	Mondor Hospital	Créteil
France	Grenoble Hospital	Grenoble
France	Institut Paoli Calmettes	Marseille
France	CHU	Nantes
France	St Louis Hospital	Paris
France	Rennes University Hospital	Rennes
France	Strasbourg University Hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Secondary	Trastuzumab efficiency concerning transfusional needs
Secondary	Overall survival
Secondary	Leukemia free survival
Secondary	cytogenetic response rate
Secondary	Trastuzumab tolerance profile