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

Phase 2

• Conditions: Lymphoblastic Lymphoma

• Registration Number: NCT00195871
• Lead Sponsor: Centre Henri Becquerel

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).

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-07
• Primary Completion: 2014-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Event free survival	2 y

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Cliniques Universitaires U C L de Mont Godinne; 🇧🇪 Yvoir, Belgium

Edouard Herriot Hospital; 🇫🇷 Lyon, France

Chr de La Citadelle; 🇧🇪 Liege, Belgium

Centre Hospitalier de La Region Annecienne; 🇫🇷 Annecy, France

Centre Hospitalier de Lens; 🇫🇷 Lens, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Saint-Louis Hospital; 🇫🇷 Paris, France

Institut Paoli Calmettes; 🇫🇷 Marseilles, France

Institut de Cancerologie de La Loire; 🇫🇷 Saint Priest En Jarez, France

Bretonneau Hospital; 🇫🇷 Tours, France

Chu de Brabois; 🇫🇷 Vandoeuvre Les Nancy, France

La Pitie Salpetriere Hospital; 🇫🇷 Paris, France

Chu de Grenoble; 🇫🇷 Grenoble, France

Marechal Joffre Hospital; 🇫🇷 Perpignan, France

Chu de Reims Robert Debre Hospital; 🇫🇷 Reims, France

Pierre Benite Hospital; 🇫🇷 Lyon, France

C H U D'Angers; 🇫🇷 Angers, France

Centre Hospitalier de Poitiers; 🇫🇷 Poitiers, France

Cochin Hospital; 🇫🇷 Paris, France