Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults
- Conditions
- Leukemia, Lymphocytic
- Registration Number
- NCT00327678
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1080
- 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
- Lymphoblastic lymphoma
- ALL 3
- Chronic myeloid leukemia
- Severe organ condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage) January 2014 Event free survival for all patients January 2014
- Secondary Outcome Measures
Name Time Method CR in 1 or 2 courses January 2014 Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 January 2014 Relapse January 2014 Death in induction January 2014 Death in first CR January 2014 Relapse free survival January 2014 Overall Survival January 2014
Trial Locations
- Locations (1)
Group for Research in Adult Acute Lymphoblastic Leukemia - GRAALL -
🇫🇷Lyon, France