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

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ClinicalTrials.gov Identifier: NCT00195871
Recruitment Status : Unknown
Verified November 2013 by Stephane Lepretre, Centre Henri Becquerel.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : November 7, 2013
Sponsor:
Information provided by (Responsible Party):
Stephane Lepretre, Centre Henri Becquerel

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 Type : Interventional  (Clinical Trial)
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 : February 2004
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2015



Intervention Details:
    Drug: Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide
    coventional dosages
    Other Name: nono
    Procedure: hematopoietic stem cell allograft
    conventional procedures


Primary Outcome Measures :
  1. Event free survival [ Time Frame: 2 y ]

Secondary Outcome Measures :
  1. Disease Free Survival ; Complete response rate ; Overall Survival ; Progression rate; Relapse rate ; Central Nervous System or meningeal relapse rate ; medullary relapse rate ; toxicities. [ Time Frame: 2 y ]


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195871


Locations
Belgium
Chr de La Citadelle
Liege, Belgium, 4000
Cliniques Universitaires U C L de Mont Godinne
Yvoir, Belgium, 5530
France
C H U D'Angers
Angers, France, 49033
Centre Hospitalier de La Region Annecienne
Annecy, France, 74011
Chu de Grenoble
Grenoble, France, 38043
Centre Hospitalier de Lens
Lens, France, 62300
Edouard Herriot Hospital
Lyon, France, 69437
Pierre Benite Hospital
Lyon, France, 69495
Institut Paoli Calmettes
Marseilles, France, 13273
Saint-Louis Hospital
Paris, France, 75000
La Pitie Salpetriere Hospital
Paris, France, 75013
Cochin Hospital
Paris, France, 75014
Marechal Joffre Hospital
Perpignan, France, 66046
Centre Hospitalier de Poitiers
Poitiers, France, 86000
Chu de Reims Robert Debre Hospital
Reims, France, 51092
Centre Henri Becquerel
Rouen, France, 76038
Institut de Cancerologie de La Loire
Saint Priest En Jarez, France, 42271
Bretonneau Hospital
Tours, France, 37044
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

Additional Information:
Publications:
Responsible Party: Stephane Lepretre, Principal Investigator, Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT00195871     History of Changes
Other Study ID Numbers: LL03
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 7, 2013
Last Verified: November 2013

Keywords provided by Stephane Lepretre, Centre Henri Becquerel:
Non-Hodgkin
Lymphoma
Lymphoblastic

Additional relevant MeSH terms:
Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Cyclophosphamide
Methotrexate
Cytarabine
Prednisone
Etoposide
Vincristine
Daunorubicin
Asparaginase
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents