Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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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

Conditions
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Leukemia, Lymphocytic

Intervention / Treatment
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* Drug: Rituximab
* Drug: Imatinib Mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|nan|
|Drug: Imatinib Mesylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR in 1 or 2 courses |  | January 2014 | 
| Death in induction |  | January 2014 | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | January 2014 | 
| Death in first CR |  | January 2014 | 
| Relapse |  | January 2014 | 
| Relapse free survival |  | January 2014 | 
| Overall Survival |  | January 2014 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALL,, young patients,, chemotherapy,, Mabtera,, Imatinib,, allogeneic transplant