Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties of recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin (trastuzumab) | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Secondary outcomes (5)
- measure
- Trastuzumab efficiency concerning transfusional needs
- measure
- Overall survival
- measure
- Leukemia free survival
- measure
- cytogenetic response rate
- measure
- Trastuzumab tolerance profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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%
References
Publications (1)
- DERIVEDChevallier 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 22267607