Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

Leukemia, Lymphocytic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327678
• Other study ID #: GRAALL 2005
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2006
• Last updated: June 23, 2016
• Start date: May 2006
• Est. completion date: April 2014

Study information

• Verified date: March 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 1080
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Rituximab

• Imatinib Mesylate

Locations

Country	Name	City	State
France	Group for Research in Adult Acute Lymphoblastic Leukemia - GRAALL -	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Group for Research in Adult Acute Lymphoblastic Leukemia

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival for all patients		January 2014	No
Primary	GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage)		January 2014	No
Secondary	CR in 1 or 2 courses		January 2014	No
Secondary	Death in induction		January 2014	No
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		January 2014	No
Secondary	Death in first CR		January 2014	No
Secondary	Relapse		January 2014	No
Secondary	Relapse free survival		January 2014	No
Secondary	Overall Survival		January 2014	No