Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

This study is currently recruiting participants.

Verified January 2013 by Group for Research in Adult Acute Lymphoblastic Leukemia

Sponsor:

Collaborators:

Projet Hospitalier de Recherche Clinique n°AOM04144 - P040429

Assistance Publique - Hôpitaux de Paris

Information provided by (Responsible Party):

Herve DOMBRET, Group for Research in Adult Acute Lymphoblastic Leukemia

ClinicalTrials.gov Identifier:

NCT00327678

First received: May 16, 2006

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2006

Last Updated Date

January 29, 2013

Start Date ^ICMJE

May 2006

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Event free survival for all patients [ Time Frame: January 2014 ] [ Designated as safety issue: No ]
GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage) [ Time Frame: January 2014 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Event free survival for all patients
GRAAPH : Percentage of patient with MRD < 10-4 after induction and/or consolidation (= salvage)

Change History

Complete list of historical versions of study NCT00327678 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

CR in 1 or 2 courses [ Time Frame: January 2014 ] [ Designated as safety issue: No ]
Death in induction [ Time Frame: January 2014 ] [ Designated as safety issue: No ]
Toxicity in induction [ Time Frame: January 2014 ] [ Designated as safety issue: No ]
Death in first CR [ Time Frame: January 2014 ] [ Designated as safety issue: No ]
Relapse [ Time Frame: January 2014 ] [ Designated as safety issue: No ]
Disease free survival [ Time Frame: January 2014 ] [ Designated as safety issue: No ]
Survival [ Time Frame: January 2014 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

CR in 1 or 2 courses,
Death in induction,
Toxicity in induction,
Death in first CR,
Relapse,
Disease free survival,
Survival

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

Official Title ^ICMJE

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

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 GRAALL 2005 R: B ALL non Ph CD20+ GRAAPH 2005: ALL Ph.

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.

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.

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Leukemia, Lymphocytic

Intervention ^ICMJE

Drug: Rituximab
Drug: Imatinib Mesylate

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1080

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 59 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Secretariat GRAALL		graall.leukemia@gmail.com
Contact: Xavier THOMAS, MD, PHD		graall.leukemia@gmail.com

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00327678

Other Study ID Numbers ^ICMJE

GRAALL 2005

Has Data Monitoring Committee

Responsible Party

Herve DOMBRET, Group for Research in Adult Acute Lymphoblastic Leukemia

Study Sponsor ^ICMJE

Group for Research in Adult Acute Lymphoblastic Leukemia

Collaborators ^ICMJE

Projet Hospitalier de Recherche Clinique n°AOM04144 - P040429
Assistance Publique - Hôpitaux de Paris

Investigators ^ICMJE

Study Chair:

HERVE DOMBRET, MD, PHD

GRAALL Group

Information Provided By

Group for Research in Adult Acute Lymphoblastic Leukemia

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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