Leukemia, Lymphocytic
Conditions
Keywords
ALL,, young patients,, chemotherapy,, Mabtera,, Imatinib,, allogeneic transplant
Brief summary
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)
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival for all patients | January 2014 |
| GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage) | January 2014 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | January 2014 |
| Death in first CR | January 2014 |
| CR in 1 or 2 courses | January 2014 |
| Relapse free survival | January 2014 |
| Overall Survival | January 2014 |
| Relapse | January 2014 |
| Death in induction | January 2014 |
Countries
France