Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

This study has been completed.
Sponsor:
Collaborator:
Group for Research in Adult Acute Lymphoblastic Leukemia
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00327678
First received: May 16, 2006
Last updated: June 23, 2016
Last verified: March 2016
  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 (N=810 patients planned).
  • GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned).
  • GRAAPH 2005: ALL Ph+ (N=270 patients planned)

Condition Intervention Phase
Leukemia, Lymphocytic
Drug: Rituximab
Drug: Imatinib Mesylate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ 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 ]
  • Relapse free survival [ Time Frame: January 2014 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: January 2014 ] [ Designated as safety issue: No ]

Enrollment: 1080
Study Start Date: May 2006
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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.

(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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Group for Research in Adult Acute Lymphoblastic Leukemia - GRAALL -
Lyon, France, 69
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Group for Research in Adult Acute Lymphoblastic Leukemia
Investigators
Study Chair: HERVE DOMBRET, MD, PHD GRAALL Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00327678     History of Changes
Other Study ID Numbers: GRAALL 2005 
Study First Received: May 16, 2006
Last Updated: June 23, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ALL,
young patients,
chemotherapy,
Mabtera,
Imatinib,
allogeneic transplant

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

ClinicalTrials.gov processed this record on July 25, 2016