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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stephane Lepretre, Centre Henri Becquerel
ClinicalTrials.gov Identifier:
NCT00195871
First received: September 12, 2005
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Centre Henri Becquerel:

Primary Outcome Measures:
  • Event free survival [ Time Frame: 2 y ] [ Designated as safety issue: No ]

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. [ Time Frame: 2 y ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: February 2004
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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
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).

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Pierre Benite Hospital
Lyon, France, 69495
Edouard Herriot Hospital
Lyon, France, 69437
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
  More Information

Additional Information:
Publications:
Responsible Party: Stephane Lepretre, Principal Investigator, Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT00195871     History of Changes
Other Study ID Numbers: LL03
Study First Received: September 12, 2005
Last Updated: November 6, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on September 18, 2014