IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: No masking 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:
|
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 21, 2017