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

NCT ID: NCT00195871

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2015-12-31

Brief Summary

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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

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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).

Conditions

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Lymphoblastic Lymphoma

Keywords

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Non-Hodgkin Lymphoma Lymphoblastic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide

coventional dosages

Intervention Type DRUG

hematopoietic stem cell allograft

conventional procedures

Intervention Type PROCEDURE

Other Intervention Names

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nono

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Stephane Lepretre

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephane Lepretre, MD

Role: STUDY_CHAIR

Centre Henri Becquerel, Rouen, France

Hervé Dombret, MD

Role: PRINCIPAL_INVESTIGATOR

Saint-Louis Hospital, Paris, France

Norbert Ifrah, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire d'Angers, FRANCE

Locations

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Chr de La Citadelle

Liège, , Belgium

Site Status

Cliniques Universitaires U C L de Mont Godinne

Yvoir, , Belgium

Site Status

C H U D'Angers

Angers, , France

Site Status

Centre Hospitalier de La Region Annecienne

Annecy, , France

Site Status

Chu de Grenoble

Grenoble, , France

Site Status

Centre Hospitalier de Lens

Lens, , France

Site Status

Edouard Herriot Hospital

Lyon, , France

Site Status

Pierre Benite Hospital

Lyon, , France

Site Status

Institut Paoli Calmettes

Marseille, , France

Site Status

Saint-Louis Hospital

Paris, , France

Site Status

La Pitie Salpetriere Hospital

Paris, , France

Site Status

Cochin Hospital

Paris, , France

Site Status

Marechal Joffre Hospital

Perpignan, , France

Site Status

Centre Hospitalier de Poitiers

Poitiers, , France

Site Status

Chu de Reims Robert Debre Hospital

Reims, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Institut de Cancerologie de La Loire

Saint-Priest-en-Jarez, , France

Site Status

Bretonneau Hospital

Tours, , France

Site Status

Chu de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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Belgium France

References

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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.

Reference Type BACKGROUND
PMID: 14576732 (View on PubMed)

Related Links

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http://www.gela.org

Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In French)

Other Identifiers

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LL03

Identifier Type: -

Identifier Source: org_study_id