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| Sponsor: | Group for Research in Adult Acute Lymphoblastic Leukemia |
|---|---|
| Collaborators: |
Projet Hospitalier de Recherche Clinique n°AOM04144 - P040429 Assistance Publique - Hôpitaux de Paris |
| Information provided by: | Group for Research in Adult Acute Lymphoblastic Leukemia |
| ClinicalTrials.gov Identifier: | NCT00327678 |
Purpose
This study is a multicenter trial of treatment for young ALL patients. All ALL patients will receive the same steroid pre-phase in order to evaluate sensitivity or resistance. Then, patients will be included into 3 specific trials according to biological features (immunophenotype, cytogenetics, and molecular biology).
Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) 2005: T ALL or B ALL non Ph GRAALL 2005 R: B ALL non Ph CD20+ GRAAPH 2005: ALL Ph.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Lymphocytic |
Drug: Rituximab Drug: Imatinib Mesylate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Young Adult With Acute Lymphoblastic Leukemia (ALL) : a Multicentric Protocol. GRAALL 2005 : T ALL or B ALL Non Ph GRAALL 2005 R : B ALL Non Ph CD20+ GRAAPH 2005 : ALL Ph |
| Estimated Enrollment: | 1080 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
GRAALL 2005: T ALL or B ALL non Ph
Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification.
GRAALL 2005 R: B ALL non Ph CD20+
Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification.
Randomization between Mabthera (rituximab) or no Mabthera during all induction and consolidation courses.
Allogenic transplantation will be performed depending on unfavourable risk factors.
GRAAPH 2005: ALL Ph
Randomization between an imatinib-based induction and a chemotherapy + imatinib induction.
Allogenic transplantation will be systematically performed in the presence of related or unrelated donors.
Autologous transplantation could be performed in the absence of a donor in case of Molecular Residual Disease (MRD) ≤ 10-4.
Consolidation therapy will be performed in the absence of a donor in case of MRD > 10-4.
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Secretariat GRAALL | graall.leukemia@gmail.com | |
| Contact: Xavier THOMAS, MD, PHD | graall.leukemia@gmail.com |
| France | |
| Group for Research in Adult Acute Lymphoblastic Leukemia - GRAALL - | Recruiting |
| Lyon, France, 69 | |
| Contact: Secrétariat GRAALL graall.leukemia@gmail.com | |
| Contact: Xavier THOMAS, MD, PHD graall.leukemia@gmail.com | |
| Study Chair: | HERVE DOMBRET, MD, PHD | GRAALL Group |
More Information
| Responsible Party: | Marie CASTERA, Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00327678 History of Changes |
| Other Study ID Numbers: | GRAALL 2005 |
| Study First Received: | May 16, 2006 |
| Last Updated: | February 5, 2009 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
ALL, young patients, chemotherapy, |
Mabtera, Imatinib, allogeneic transplant |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab |
Imatinib Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
