Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children (ESPHALL)

Rennes University Hospital

Status and phase: Completed; Phase 2

Conditions: Philadelphia Chromosome; Acute Lymphoblastic Leukemia

Treatments: Drug: Standard chemotherapy + Imatinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00287105

PHRC/04-04

EUDRACT 2004-001647-30

CIC0203/043

Details and patient eligibility

About

The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.

Full description

Recent advances in treatment have increased the cure of childhood ALL to 75% or better. However, attempts to improve results for resistant subtypes of ALL, such as Ph+ ALL, have been largely unsuccessful. Imatinib, an inhibitor of protein-tyrosine kinases, is currently being tested in several phase I, II and III trials covering most Chronic Myeloid Leukemia patient populations and patients with overtly relapsed or refractory Ph+ALL. Pediatric patients with Ph+ALL will receive Imatinib, added to intensive, post-induction BFM-type chemotherapy. The endpoint will be the evaluation on the long-term clinical outcome, in particular on the Disease Free Survival (DFS).

Enrollment: 49 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and adolescents aged 1 to 17 years at diagnostic
• Documented Ph+ ALL
• Eligibility for the current local prospective therapeutic study of childhood ALL
• Informed consent given by the parents or by legal guardian

Exclusion criteria

• Abnormal hepatic functions
• Abnormal renal functions
• Active systemic bacterial, fungal or viral infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

49 participants in 2 patient groups

Good risk Ph+ALL

Other group

Description:

For protocols which adopt a steroid prephase: patients who are Prednisone-good responder and achieve CR after the induction course. For protocols which do not adopt steroid prephase: patients who have M1/M2 BM at day 15 or M1 BM at day 21 and achieve CR after the induction course. Expected stratification in this group: 70-75%.

Treatment:

Drug: Standard chemotherapy + Imatinib

Poor risk Ph+ALL

Other group

Description:

For protocols which adopt a steroid prephase: patients who are Prednisone poor-responders. For protocol which do not adopt a steroid prephase: patients who have M3 BM at day 15 or M2/M3 BM at day 21. For all protocols: patients who do not achieve CR after the induction course. Expected stratification: 25-30%.

Treatment:

Drug: Standard chemotherapy + Imatinib