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

Lymphoblastic Lymphoma Clinical Trial

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).

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00195871
• Other study ID #: LL03
• Status: Unknown status
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: November 6, 2013
• Start date: February 2004
• Est. completion date: December 2015

Study information

• Verified date: November 2013
• Source: Centre Henri Becquerel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 155
• Est. completion date: December 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia, Lymphoid
• Lymphoblastic Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide
coventional dosages

Procedure:
• hematopoietic stem cell allograft
conventional procedures

Locations

Country	Name	City	State
Belgium	Chr de La Citadelle	Liege
Belgium	Cliniques Universitaires U C L de Mont Godinne	Yvoir
France	C H U D'Angers	Angers
France	Centre Hospitalier de La Region Annecienne	Annecy
France	Chu de Grenoble	Grenoble
France	Centre Hospitalier de Lens	Lens
France	Edouard Herriot Hospital	Lyon
France	Pierre Benite Hospital	Lyon
France	Institut Paoli Calmettes	Marseilles
France	Cochin Hospital	Paris
France	La Pitie Salpetriere Hospital	Paris
France	Saint-Louis Hospital	Paris
France	Marechal Joffre Hospital	Perpignan
France	Centre Hospitalier de Poitiers	Poitiers
France	Chu de Reims Robert Debre Hospital	Reims
France	Centre Henri Becquerel	Rouen
France	Institut de Cancerologie de La Loire	Saint Priest En Jarez
France	Bretonneau Hospital	Tours
France	Chu de Brabois	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (1)

Le Gouill S, Lepretre S, Brière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival		2 y
Secondary	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

External Links

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