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Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults
This study is currently recruiting participants.
Verified by Group for Research in Adult Acute Lymphoblastic Leukemia, February 2009
First Received: May 16, 2006   Last Updated: February 5, 2009   History of Changes
Sponsor: Group for Research in Adult Acute Lymphoblastic Leukemia
Collaborators: Projet Hospitalier de Recherche Clinique n°AOM04144 - P040429
Assistance Publique - Hôpitaux de Paris
Information provided by: Group for Research in Adult Acute Lymphoblastic Leukemia
ClinicalTrials.gov Identifier: NCT00327678
  Purpose

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.


Condition Intervention Phase
Leukemia, Lymphocytic
Drug: Rituximab
Drug: Imatinib Mesylate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Group for Research in Adult Acute Lymphoblastic Leukemia:

Primary Outcome Measures:
  • Event free survival for all patients
  • GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage)

Secondary Outcome Measures:
  • CR in 1 or 2 courses
  • Death in induction
  • Toxicity in induction
  • Death in first CR
  • Relapse
  • Disease free survival
  • Survival

Estimated Enrollment: 1080
Study Start Date: May 2006
Estimated Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327678

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

Locations
France
Group for Research in Adult Acute Lymphoblastic Leukemia - GRAALL - Recruiting
Lyon, France, 69
Contact: Secrétariat GRAALL         graall.leukemia@gmail.com    
Contact: Xavier THOMAS, MD, PHD         graall.leukemia@gmail.com    
Sponsors and Collaborators
Group for Research in Adult Acute Lymphoblastic Leukemia
Projet Hospitalier de Recherche Clinique n°AOM04144 - P040429
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: HERVE DOMBRET, MD, PHD GRAALL Group
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris ( Marie CASTERA )
Study ID Numbers: GRAALL 2005
Study First Received: May 16, 2006
Last Updated: February 5, 2009
ClinicalTrials.gov Identifier: NCT00327678     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Group for Research in Adult Acute Lymphoblastic Leukemia:
ALL,
young patients,
chemotherapy,
Mabtera,
Imatinib,
allogeneic transplant

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Leukemia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on February 08, 2010