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Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children (ESPHALL)
This study has been completed.
Sponsor:
Rennes University Hospital
Collaborators:
Ministry of Health, France
Novartis
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00287105
First received: February 3, 2006
Last updated: February 14, 2017
Last verified: February 2017
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Purpose
The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.
| Condition | Intervention | Phase |
|---|---|---|
| Acute Lymphoblastic Leukemia Philadelphia Chromosome | Drug: Standard chemotherapy + Imatinib | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Rennes University Hospital:
Primary Outcome Measures:
- 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. [ Time Frame: 2 years ]
Secondary Outcome Measures:
- Compare long term outcome between patients treated by BFM-chemotherapy and patient undergoing more intensive chemotherapy (protocole COGAALL0031 : Children Oncology Group-USA). [ Time Frame: 2 years ]
- Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups. [ Time Frame: 2 years ]
- Pattern of molecular response (MRD) [ Time Frame: 5 time points between S4 and S22 ]
- Conversion rate to CR in patients resistant to the first part of the induction phase of chemotherapy included in the Poor-risk group. [ Time Frame: 2 years ]
| Enrollment: | 49 |
| Actual Study Start Date: | December 2005 |
| Study Completion Date: | December 31, 2016 |
| Primary Completion Date: | December 31, 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Good risk Ph+ALL
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%.
|
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
Other Names:
|
|
Poor risk Ph+ALL
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%.
|
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
Other Names:
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Detailed 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).
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00287105
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287105
Locations
| France | |
| Service d'hématologie pédiatrique CHRU | |
| Amiens, France, 80080 | |
| Service hématologie pédiatrique Hôpital Saint-Jacques | |
| Besancon, France, 25000 | |
| Service d'hémato-oncologie - Hôpital des Enfants Pellegrin | |
| Bordeaux, France, 33076 | |
| Hôpital Morvan | |
| Brest, France, 29200 | |
| Hématologie oncologie pédiatrique-CHU Caen | |
| Caen, France | |
| Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu | |
| Clermont-Ferrand, France, 63058 | |
| Dijon hôpital d'enfants | |
| Dijon, France, 21034 | |
| Hémato-Oncologie Pédiatrique - Hôpital d'Enfants | |
| Dijon, France, 21034 | |
| Pédiatrie CHU - Hôpital Nord | |
| Grenoble, France, 38043 | |
| Hôpital Jeanne de Flandre | |
| Lille, France, 59037 | |
| Limoges University Hospital | |
| Limoges, France, 87042 | |
| Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique | |
| Lyon, France | |
| Service hématologie pédiatrique CHU la Timone | |
| Maseille, France, 13385 | |
| Hôpital Arnaud de Villeneuve | |
| Montpellier, France | |
| CHR Hôtel Dieu | |
| Nantes, France | |
| Hôpital de l'Archet | |
| Nice, France | |
| Service hématologie Hopital Necker | |
| Paris, France, 75015 | |
| Hématologie Pédiatrique - Hôpital Trousseau | |
| Paris, France, 75571 | |
| Hémato-immunologie-Robert Debré | |
| Paris, France | |
| Hématologie Hôpital Jean Bernard | |
| Poitiers, France, 86021 | |
| Hématologie pédiatrique-Hopital américain | |
| Reims, France | |
| Service d'hématologie pédiatrique - Hôpital Sud | |
| Rennes, France, 35033 | |
| Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle | |
| Rouen, France, 76031 | |
| Hématologie, Oncologie pédiatrique-CHU Saint Etienne | |
| Saint Etienne, France | |
| Pédiatrie Hôpital Hautepierre | |
| Strasbourg, France, 67098 | |
| Hopital des enfants | |
| Toulouse, France | |
| CHU- Centre Gatien de Clocheville | |
| Tours, France, 37044 | |
| Hôpital d'enfants | |
| Vandoeuvre Les Nancy, France, 54511 | |
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Novartis
Investigators
| Study Director: | Andrea Biondi, MD | Ospedale S. Gerardo - Monza |
| Principal Investigator: | Virginie Gandemer, MD | Rennes University Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00287105 History of Changes |
| Other Study ID Numbers: |
EUDRACT 2004-001647-30 PHRC/04-04 CIC0203/043 |
| Study First Received: | February 3, 2006 |
| Last Updated: | February 14, 2017 |
Keywords provided by Rennes University Hospital:
|
Chemotherapy Leukemia Children Philadelphia chromosome Protein-tyrosine kinase inhibitor |
Additional relevant MeSH terms:
|
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017