Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and the efficacy of an adult acute lymphoblastic leukaemia type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification.

Detailed Description
-----------------
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).

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

Conditions
-----------------
Lymphoblastic Lymphoma

Intervention / Treatment
-----------------
* Drug: Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide
* Procedure: hematopoietic stem cell allograft


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide|coventional dosages|
|Procedure: hematopoietic stem cell allograft|conventional procedures|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival |  | 2 y | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival ; Complete response rate ; Overall Survival ; Progression rate; Relapse rate ; Central Nervous System or meningeal relapse rate ; medullary relapse rate ; toxicities. |  | 2 y | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Hodgkin, Lymphoma, Lymphoblastic