Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
299 participants
INTERVENTIONAL
2008-09-30
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
observation : 3 years maintenance period with assesments and surveillance every 2 months
Watch and wait
No treatment patient follow-up every 2 months during 3 years
2
maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance
Rituximab
2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
Interventions
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Rituximab
2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years
Watch and wait
No treatment patient follow-up every 2 months during 3 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initial immunophenotyping with CD20 and CD5.
* CD20+.
* t (11;14) by karyote, FISH, molecular biology or immunohistochemistry (Bcl-1)
* Patient no previous treated.
* At least one tumor site accessible for assessment
* Aged \> 18 years \< 65
* ECOG \< or = 2.
* No other neoplasms apart from resected basal cell carcinoma or in situ carcinoma.
* signed informed consent
* FEVG 50%
Exclusion Criteria
* ECOG \> or = 3
* relapse
* serology VIH + Hepatite +
* diabetis
18 Years
65 Years
ALL
No
Sponsors
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Lymphoma Study Association
OTHER
French Innovative Leukemia Organisation
OTHER
Responsible Party
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Principal Investigators
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Steven LE GOUILL, MD
Role: PRINCIPAL_INVESTIGATOR
French Innovative Leukemia Organisation
Locations
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Regional University Hospital
Nantes, , France
Countries
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References
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Sarkozy C, Callanan M, Thieblemont C, Oberic L, Burroni B, Bouabdallah K, Damaj G, Tessoulin B, Ribrag V, Houot R, Morschhauser F, Griolet S, Joubert C, Cacheux V, Delwail V, Safar V, Gressin R, Cheminant M, Delfau-Larue MH, Hermine O, Macintyre E, Le Gouill S. Obinutuzumab vs rituximab for transplant-eligible patients with mantle cell lymphoma. Blood. 2024 Jul 18;144(3):262-271. doi: 10.1182/blood.2024023944.
Le Gouill S, Thieblemont C, Oberic L, Moreau A, Bouabdallah K, Dartigeas C, Damaj G, Gastinne T, Ribrag V, Feugier P, Casasnovas O, Zerazhi H, Haioun C, Maisonneuve H, Houot R, Jardin F, Van Den Neste E, Tournilhac O, Le Du K, Morschhauser F, Cartron G, Fornecker LM, Canioni D, Callanan M, Bene MC, Salles G, Tilly H, Lamy T, Gressin R, Hermine O; LYSA Group. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017 Sep 28;377(13):1250-1260. doi: 10.1056/NEJMoa1701769.
Related Links
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FILO Website
Other Identifiers
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Manteau 2007 SJ "LYMA"
Identifier Type: -
Identifier Source: org_study_id
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