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A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL).

Phase 2
18 Years
59 Years
Open (Enrolling)
Lymphoblastic Lymphoma

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Trial Information

A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL).

Lymphoblastic lymphomas (LL) are rare and represent less than 2% of the malignant
non-Hodgkin lymphomas (NHL). The distinction between a LL and an acute lymphoblastic
leukaemia (ALL) is difficult; it is arbitrarily based on the percentage of medullary blasts.
Above 20% of blasts, it is an ALL. In both cases, the same type of cells is affected: the
lymphoblast. Thus the LL were treated either as aggressive NHL or as ALL. The results of the
various clinical studies, have shown a best efficacy of ALL type treatments(in terms of
overall survival and disease free survival). These treatments are based on an induction
phase with reinforced cyclophosphamide and L-asparaginase, and a re-use of the first drugs
after consolidation (delayed intensification). The prognostic factors of ALL are now better
defined, determining risk groups. According to these prognostic indicators, the allograft
could be proposed in first complete remission. Indicators are biological (hyperleukocytosis,
chromosomal abnormalities as t(4;11), t(9;22), t(1;19) translocations), clinical (central
nervous system involvement), evolutive (salvage therapy needed to obtain complete
remission), consideration of early response (cortico-sensibility and chemo-sensibility) and
molecular responses (residual disease). On the other hand, the prognostic factors of LL are
not well known. This study should permit to better define them. So the prognostic indicators
of ALL, in this study, will be decisional for the indication of allograft. This treatment is
based on a parallel currently recruiting adult patients with ALL (protocol GRAALL 2003).

Inclusion Criteria:

- Patient with lymphoblastic lymphoma.

- Aged from 18 to 59 years.

- Medullary blasts rate less than 20%

- Non previously treated

- With or without central nervous system or meningeal involvement.

- No contra-indication to anthracyclines.

- No contra-indication to intensive treatments

- Negative HIV serology test

- Negative pregnancy test for all female patients of childbearing potential.

- Able to be regularly followed up.

Exclusion Criteria:

- Evolutive cancer with the exception of non melanoma skin tumours or stage 0 (in situ)
cervical carcinoma.

- Prior treatment with chemotherapy.

- Lymphoblastic Transformation of chronic myeloid leukaemia

- Patient unable to be regularly followed-up.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event free survival

Outcome Time Frame:

2 y

Safety Issue:


Principal Investigator

Stephane Lepretre, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Henri Becquerel, Rouen, France


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

Study ID:




Start Date:

February 2004

Completion Date:

December 2012

Related Keywords:

  • Lymphoblastic Lymphoma
  • Non-Hodgkin
  • Lymphoma
  • Lymphoblastic
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin