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

Acute Lymphoblastic Leukemia Clinical Trial

— ESPHALL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287105
• Other study ID #: EUDRACT 2004-001647-30
• Secondary ID: PHRC/04-04CIC020
• Status: Completed
• Phase: Phase 2
• Start date: December 2005
• Est. completion date: March 3, 2017

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 3, 2017
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Philadelphia Chromosome
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Standard chemotherapy + Imatinib
Patients receive Imatinib together with the standard chemotherapy regimen of phase IB and after each of three consecutive blocks of the standard chemotherapy in the consolidation phase

Locations

Country	Name	City	State
France	Service d'hématologie pédiatrique CHRU	Amiens
France	Service hématologie pédiatrique Hôpital Saint-Jacques	Besancon
France	Service d'hémato-oncologie - Hôpital des Enfants Pellegrin	Bordeaux
France	Hôpital Morvan	Brest
France	Hématologie oncologie pédiatrique-CHU Caen	Caen
France	Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu	Clermont-Ferrand
France	Hémato-Oncologie Pédiatrique - Hôpital d'Enfants	Dijon
France	Pédiatrie CHU - Hôpital Nord	Grenoble
France	Hôpital Jeanne de Flandre	Lille
France	Limoges University Hospital	Limoges
France	Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique	Lyon
France	Hôpital Arnaud de Villeneuve	Montpellier
France	Hémato-immunologie-Robert Debré	Paris
France	Hématologie Pédiatrique - Hôpital Trousseau	Paris
France	Hématologie Hôpital Jean Bernard	Poitiers
France	Hématologie pédiatrique-Hopital américain	Reims
France	Service d'hématologie pédiatrique - Hôpital Sud	Rennes
France	Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle	Rouen
France	Hématologie, Oncologie pédiatrique-CHU Saint Etienne	Saint Etienne
France	Hopital des enfants	Toulouse
France	CHU- Centre Gatien de Clocheville	Tours
France	Hôpital d'enfants	Vandoeuvre Les Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France, Novartis

Country where clinical trial is conducted

France, 

References & Publications (2)

Biondi A, Gandemer V, De Lorenzo P, Cario G, Campbell M, Castor A, Pieters R, Baruchel A, Vora A, Leoni V, Stary J, Escherich G, Li CK, Cazzaniga G, Cave H, Bradtke J, Conter V, Saha V, Schrappe M, Grazia Valsecchi M. Imatinib treatment of paediatric Phil — View Citation

Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Arico M, Rottgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS). DFS will be calculated as the time from inclusion to either one of the following events: relapse, death in CCR, second malignancies.		2 years
Secondary	Compare long term outcome between patients treated by BFM-chemotherapy and patient undergoing more intensive chemotherapy (protocole COGAALL0031 : Children Oncology Group-USA).		2 years
Secondary	Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups.		2 years
Secondary	Pattern of molecular response (MRD)		5 time points between S4 and S22
Secondary	Conversion rate to CR in patients resistant to the first part of the induction phase of chemotherapy included in the Poor-risk group.		2 years

External Links

•   Primary Publication