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

Sponsor

Centre Henri Becquerel (Other)

Overall Status

Unknown status

CT.gov ID

NCT00195871

Collaborator

(none)

155

Enrollment

Locations

142

Duration (Months)

8.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoblastic Lymphoma	Drug: Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide Procedure: hematopoietic stem cell allograft	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

155 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2004

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Dec 1, 2015

Outcome Measures

Primary Outcome Measures

Event free survival [2 y]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Chr de La Citadelle	Liege	Belgium	4000
2	Cliniques Universitaires U C L de Mont Godinne	Yvoir	Belgium	5530
3	C H U D'Angers	Angers	France	49033
4	Centre Hospitalier de La Region Annecienne	Annecy	France	74011
5	Chu de Grenoble	Grenoble	France	38043
6	Centre Hospitalier de Lens	Lens	France	62300
7	Edouard Herriot Hospital	Lyon	France	69437
8	Pierre Benite Hospital	Lyon	France	69495
9	Institut Paoli Calmettes	Marseilles	France	13273
10	Saint-Louis Hospital	Paris	France	75000
11	La Pitie Salpetriere Hospital	Paris	France	75013
12	Cochin Hospital	Paris	France	75014
13	Marechal Joffre Hospital	Perpignan	France	66046
14	Centre Hospitalier de Poitiers	Poitiers	France	86000
15	Chu de Reims Robert Debre Hospital	Reims	France	51092
16	Centre Henri Becquerel	Rouen	France	76038
17	Institut de Cancerologie de La Loire	Saint Priest En Jarez	France	42271
18	Bretonneau Hospital	Tours	France	37044
19	Chu de Brabois	Vandoeuvre Les Nancy	France	54511

Sponsors and Collaborators

Centre Henri Becquerel

Investigators

Study Chair: Stephane Lepretre, MD, Centre Henri Becquerel, Rouen, France
Principal Investigator: Hervé Dombret, MD, Saint-Louis Hospital, Paris, France
Principal Investigator: Norbert Ifrah, MD, Centre Hospitalier Universitaire d'Angers, FRANCE