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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00327678
Enrollment
1080
Registered
2006-05-18
Start date
2006-05-31
Completion date
2014-04-30
Last updated
2016-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphocytic

Keywords

ALL,, young patients,, chemotherapy,, Mabtera,, Imatinib,, allogeneic transplant

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.

Interventions

DRUGRituximab
DRUGImatinib Mesylate

Sponsors

Group for Research in Adult Acute Lymphoblastic Leukemia
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Event free survival for all patientsJanuary 2014
GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage)January 2014

Secondary

MeasureTime frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0January 2014
Death in first CRJanuary 2014
CR in 1 or 2 coursesJanuary 2014
Relapse free survivalJanuary 2014
Overall SurvivalJanuary 2014
RelapseJanuary 2014
Death in inductionJanuary 2014

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026