Clinical trial · Interventional
Rituximab Maintenance Therapy in Aggressive CD20 (Cluster of Differentiation Antigen 20) Positive Lymphoma and Mantle Cell Lymphoma
Rituximab Maintenance Therapy Versus Observation in Aggressive CD20+ Lymphoma and Mantle Cell Lymphoma - a Prospective Randomized Phase III Trial
NCT01933711CI-TRIAL-00022144unknownPhase 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)
Clinical and pharmacokinetic data suggest that the effect of rituximab could be improved by prolonged exposure to the drug. To test for this hypothesis we performed a prospective randomized trial of rituximab maintenance therapy versus observation in patients (pts) with aggressive CD20+ B-cell lymphoma and mantle cell lymphoma.
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 |
|---|---|---|---|
| CD20+ Aggressive Lymphoma, Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rituximab maintenance
- description
- maintenance therapy with rituximab (375 mg/m2) administered every 3 months for 2 years.
- interventionNames
- Drug: rituximab
- type
- NO_INTERVENTION
- label
- Observation
- description
- observational arm, no intervention
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 24 months after randomization
- description
- Primary endpoint of the study was progression free survival (PFS)
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * aggressive B-cell lymphoma or mantle cell lymphoma * CR (complete remission) oder CRu (complete remission unconfirmed) after previous therapy * PR (partial remission) only when PET is negative * minimal age 18 years * CD20+ expression on tumor cells * effective contraception * Karnofsky status \> 60 * written informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.