Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children (ESPHALL)
This study is ongoing, but not recruiting participants.
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 17, 2015
Last verified: February 2015
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
Genetics Home Reference related topics:
tetrasomy 18p
Genetic and Rare Diseases Information Center resources:
Acute Lymphoblastic Leukemia
Acute Monoblastic Leukemia
Acute Myeloblastic Leukemia Type 5
Children's Interstitial Lung Disease
Lymphosarcoma
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Pattern of molecular response (MRD) [ Time Frame: 5 time points between S4 and S22 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (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 |
| Genders Eligible for Study: | Both |
| 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 | |
| Hémato-Oncologie Pédiatrique - Hôpital d'Enfants | |
| Dijon, France, 21034 | |
| Dijon 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 | |
| Hémato-immunologie-Robert Debré | |
| Paris, France | |
| Hématologie Pédiatrique - Hôpital Trousseau | |
| Paris, France, 75571 | |
| Service hématologie Hopital Necker | |
| Paris, France, 75015 | |
| 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
No publications provided by Rennes University Hospital
Additional 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 17, 2015 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Rennes University Hospital:
|
Chemotherapy Leukemia Children Philadelphia chromosome Protein-tyrosine kinase inhibitor |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Philadelphia Chromosome Precursor Cell Lymphoblastic Leukemia-Lymphoma Chromosome Aberrations Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms |
Neoplasms by Histologic Type Pathologic Processes Translocation, Genetic Imatinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015