A Phase 3 interventional study of Rituximab and Imatinib Mesylate in Leukemia, Lymphocytic, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2016-06-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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:
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.
1,772 studies on the registry are indexed under Leukemia, Lymphoid; 173 are open to participants now.
This study's enrollment of 1,080 is above the median of 36 across 1,410 interventional studies indexed under Leukemia, Lymphoid.
Browse Leukemia, Lymphoid studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Event free survival for all patients
Time frame: January 2014
GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage)
Time frame: January 2014
CR in 1 or 2 courses
Time frame: January 2014
Death in induction
Time frame: January 2014
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: January 2014
Death in first CR
Time frame: January 2014
Relapse
Time frame: January 2014
Relapse free survival
Time frame: January 2014
Overall Survival
Time frame: January 2014
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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