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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00195871 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of an Adult Acute Lymphoblastic Leukemia Chemotherapy for Adult Lymphoblastic Lymphoma
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Scientific title:
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A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL). |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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160 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00195871 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Belgium
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France
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Contacts
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Name:
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Valerie Tallon |
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Address:
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Telephone:
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33232082498 |
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Email:
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valerie.tallon-simon@chb.unicancer.fr |
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Affiliation:
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Name:
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Stephane Lepretre, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Henri Becquerel, Rouen, France |
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Name:
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Norbert Ifrah, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire d'Angers , France |
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Name:
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Hervé Dombret, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint-Louis Hospital, Paris, France |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
59 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphoblastic Lymphoma
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Intervention(s)
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Drug: Prednisone, vincristine, daunorubicin , cyclophosphamide , L.-asparaginase, cytosine-arabinoside, methotrexate, etoposide
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Procedure: hematopoietic stem cell allograft
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Primary Outcome(s)
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Event free survival
[Time Frame: 2 y]
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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