Clinical trial · Interventional
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL
NCT00921414CI-TRIAL-00032698completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
| Watch and wait | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- observation : 3 years maintenance period with assesments and surveillance every 2 months
- interventionNames
- Other: Watch and wait
- type
- EXPERIMENTAL
- label
- 2
- description
- maintenance period infusions of Rituximab 375 mg/m2/2 months and assessement and surveillance
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- event-free survival (EFS) post Rituximab maintenance therapy
- timeFrame
- EFS post 4 years after maintenance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * mantle cell lymphoma * 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: * other type of lymphoma * ECOG \> or = 3 * relapse * serology VIH + Hepatite + * diabetis
References
Publications (2)
- DERIVEDSarkozy 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. PMID 38669626
- DERIVEDLe 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. PMID 28953447