Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00327678

Collaborator

Group for Research in Adult Acute Lymphoblastic Leukemia (Other)

1,080

Enrollment

Location

Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphocytic	Drug: Rituximab Drug: Imatinib Mesylate	Phase 3

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.

Study Design

Study Type:

Interventional

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 1, 2006

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Outcome Measures

Primary Outcome Measures

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

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]