NCT00327678

Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,080 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Lymphocytic

Interventions

Type	Name	Description
DRUG	Rituximab
DRUG	Imatinib Mesylate

Timeline

• Start date: 2006-05-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2006-05-18
• Last updated: 2016-06-27

Locations

1 site across 1 country: France