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

NCT00195871 | Unknown Phase 2

• 1 other identifier: LL03
• Study Type: interventional
• Target: 155
• Locations: 2 countries
• Sites: 19

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.

Conditions

Lymphoblastic Lymphoma

Keywords

Non-Hodgkin; Lymphoma; Lymphoblastic

Outcome Measures

Primary Outcomes (1)

• Event free survival

  2 y

Secondary Outcomes (1)

• 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

Interventions

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

coventional dosages

Also known as: nono

hematopoietic stem cell allograft PROCEDURE

conventional procedures

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (19)

Chr de La Citadelle

Liège, 4000, Belgium

Location

Cliniques Universitaires U C L de Mont Godinne

Yvoir, 5530, Belgium

Location

C H U D'Angers

Angers, 49033, France

Location

Centre Hospitalier de La Region Annecienne

Annecy, 74011, France

Location

Chu de Grenoble

Grenoble, 38043, France

Location

Centre Hospitalier de Lens

Lens, 62300, France

Location

Edouard Herriot Hospital

Lyon, 69437, France

Location

Pierre Benite Hospital

Lyon, 69495, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Saint-Louis Hospital

Paris, 75000, France

Location

La Pitie Salpetriere Hospital

Paris, 75013, France

Location

Cochin Hospital

Paris, 75014, France

Location

Marechal Joffre Hospital

Perpignan, 66046, France

Location

Centre Hospitalier de Poitiers

Poitiers, 86000, France

Location

Chu de Reims Robert Debre Hospital

Reims, 51092, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut de Cancerologie de La Loire

Saint-Priest-en-Jarez, 42271, France

Location

Bretonneau Hospital

Tours, 37044, France

Location

Chu de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• 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.

  PMID: 14576732 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma

Interventions

Prednisone; Vincristine; Daunorubicin; Cyclophosphamide; Asparaginase; Cytarabine; Methotrexate; Etoposide

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides

Study Officials

• Stephane Lepretre, MD

  Centre Henri Becquerel, Rouen, France

  STUDY CHAIR

• Hervé Dombret, MD

  Saint-Louis Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

• Norbert Ifrah, MD

  Centre Hospitalier Universitaire d'Angers, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 2004
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 7, 2013

Record last verified: 2013-11

Locations

FR (17); BE (2)