EsPhALL 2004 An Open-label, Randomized Phase II/III Study to Compare the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL)

EsPhALL 2004 An Open-label, Randomized Phase II/III Study to Compare the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL) - EsPhALL 2004

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005309

Enrollment

450

Registered

2013-12-19

Start date

2005-04-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C91.0 C92.1

Interventions

Group 1: Standard chemotherapy + Imatinib (Glivec), 300 mg/m²/day in 2- to 4-week courses in parallel to the post-induction chemotherapy Group 2: Standard chemotherapy

Eligibility

Sex/Gender

All

Age

12 Months to 17 Years

Inclusion criteria

Inclusion criteria: Children and adolescents aged 1-17 years at diagnosis, with documented by either cytogenetics, PCR or FISH for bcr-abl, who are eligible for the current local prospective therapeutic study of childhood ALL and for whom informed consent was given by the parents or by legal guardian.

Exclusion criteria

Exclusion criteria: 1. Abnormal hepatic function (ALAT/ASAT >10 times the upper limit of the normal range); 2. Abnormal renal function (creatinine >1.5 times the upper limit of the normal range or a calculated creatinine clearance of 80 ml/ min or less, adjusted to a body surface area of 1.73 m2); 3. Active systemic bacterial, fungal or viral infection as documented by positive cultures, radiological imaging techniques, septic shock symptoms

Design outcomes

Secondary

Measure	Time frame
1. Feasibility and safety of the addition of IMATINIB to conventional chemotherapy schedule. 2. Long term clinical outcome (EFS, survival) 3. Pattern of molecular response at the 5 scheduled time points for MRD measurement. 4. Conversion rate to CR in patients resistant to the first part of the induction phase of chemotherapy included in the Poor-risk group.	—

Primary

Measure	Time frame
Long term clinical outcome in Ph+ALL, will be evaluated with Disease free survival (DFS). DFS will be calculated as the time from accrual to either one of the following events: relapse, death in CCR, second malignancies.	—

Countries

Austria, Belgium, Czechia, Germany, Italy, Netherlands, Switzerland, United Kingdom

Contacts

Public ContactMartin Schrappe

ALL-BFM StudienzentrumUniversitätsklinkum Schleswig-Holstein, Campus Kiel

m.schrappe@pediatrics.uni-kiel.de0431-597-1622

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026