Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults
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| ClinicalTrials.gov Identifier: NCT00327678 |
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Recruitment Status :
Completed
First Posted : May 18, 2006
Last Update Posted : June 27, 2016
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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 (N=810 patients planned).
- GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned).
- GRAAPH 2005: ALL Ph+ (N=270 patients planned)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia, Lymphocytic | Drug: Rituximab Drug: Imatinib Mesylate | Phase 3 |
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.
(N=810 patients planned)
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.(N=220 patients planned)
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. (N=270 patients planned)
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1080 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | May 2006 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | April 2014 |
- Event free survival for all patients [ Time Frame: January 2014 ]
- GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage) [ Time Frame: January 2014 ]
- CR in 1 or 2 courses [ Time Frame: January 2014 ]
- Death in induction [ Time Frame: January 2014 ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: January 2014 ]
- Death in first CR [ Time Frame: January 2014 ]
- Relapse [ Time Frame: January 2014 ]
- Relapse free survival [ Time Frame: January 2014 ]
- Overall Survival [ Time Frame: January 2014 ]
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| Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18-59 years
- ALL newly diagnosed (blast < 20%)
- Central Nervous System (CNS) positive or negative
- Signed written informed consent
- For GRAAPH trial only: t(9;22) or BCR- ABL positive
Exclusion Criteria:
- Lymphoblastic lymphoma
- ALL 3
- Chronic myeloid leukemia
- Severe organ condition
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327678
| France | |
| Group for Research in Adult Acute Lymphoblastic Leukemia - GRAALL - | |
| Lyon, France, 69 | |
| Study Chair: | HERVE DOMBRET, MD, PHD | GRAALL Group |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00327678 |
| Other Study ID Numbers: |
GRAALL 2005 |
| First Posted: | May 18, 2006 Key Record Dates |
| Last Update Posted: | June 27, 2016 |
| Last Verified: | March 2016 |
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ALL, young patients, chemotherapy, |
Mabtera, Imatinib, allogeneic transplant |
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Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab |
Imatinib Mesylate Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |