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Completed

NCT Number: NCT00327678

Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

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)

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Group for Research in Adult Acute Lymphoblastic Leukemia - GRAALL -

Lyon, 69, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

imatinib mesylate

Drug

Primary outcomes

  1. Event free survival for all patients

    Time frame: January 2014

  2. GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage)

    Time frame: January 2014

Secondary outcomes

  1. CR in 1 or 2 courses

    Time frame: January 2014

  2. Death in induction

    Time frame: January 2014

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: January 2014

  4. Death in first CR

    Time frame: January 2014

  5. Relapse

    Time frame: January 2014

  6. Relapse free survival

    Time frame: January 2014

  7. Overall Survival

    Time frame: January 2014

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Group for Research in Adult Acute Lymphoblastic Leukemia

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
May 18, 2006
Registry last updated
Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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