Know Cancer

or
forgot password

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


Phase 3
18 Years
59 Years
Open (Enrolling)
Both
Leukemia, Lymphocytic

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event free survival for all patients

Outcome Time Frame:

January 2014

Safety Issue:

No

Principal Investigator

HERVE DOMBRET, MD, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

GRAALL Group

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GRAALL 2005

NCT ID:

NCT00327678

Start Date:

May 2006

Completion Date:

January 2014

Related Keywords:

  • Leukemia, Lymphocytic
  • ALL,
  • young patients,
  • chemotherapy,
  • Mabtera,
  • Imatinib,
  • allogeneic transplant
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location