Clinical trial NCT00195871: Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma
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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoblastic Lymphoma
Keywords: Non-Hodgkin
Lymphoma
Lymphoblastic
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Event free survival
timeFrame: 2 y
Secondary outcomes:
measure: Disease Free Survival ; Complete response rate ; Overall Survival ; Progression rate; Relapse rate ; Central Nervous System or meningeal relapse rate ; medullary relapse rate ; toxicities.
timeFrame: 2 y
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Chr de La Citadelle
city: Yvoir
country: Belgium
facility: Cliniques Universitaires U C L de Mont Godinne
city: Angers
country: France
facility: C H U D'Angers
city: Annecy
country: France
facility: Centre Hospitalier de La Region Annecienne
city: Grenoble
country: France
facility: Chu de Grenoble
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Lyon
country: France
facility: Pierre Benite Hospital
city: Marseilles
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: Saint-Louis Hospital
city: Paris
country: France
facility: La Pitie Salpetriere Hospital
city: Paris
country: France
facility: Cochin Hospital
city: Perpignan
country: France
facility: Marechal Joffre Hospital
city: Poitiers
country: France
facility: Centre Hospitalier de Poitiers
city: Reims
country: France
facility: Chu de Reims Robert Debre Hospital
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Priest En Jarez
country: France
facility: Institut de Cancerologie de La Loire
city: Tours
country: France
facility: Bretonneau Hospital
city: Vandoeuvre Les Nancy
country: France
facility: Chu de Brabois
Study officials:
affiliation: Centre Henri Becquerel, Rouen, France
name: Stephane Lepretre, MD
role: STUDY_CHAIR
affiliation: Saint-Louis Hospital, Paris, France
name: Hervé Dombret, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire d'Angers, FRANCE
name: Norbert Ifrah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Gouill S, Lepretre S, Briere J, Morel P, Bouabdallah R, Raffoux E, Sebban C, Lepage E, Brice P. Adult lymphoblastic lymphoma: a retrospective analysis of 92 patients under 61 years included in the LNH87/93 trials. Leukemia. 2003 Nov;17(11):2220-4. doi: 10.1038/sj.leu.2403095.