Clinical trial · Interventional
Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years
Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma
- 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)
About 40% of Diffuse large B cell lymphoma relapse or is refractory, age is a prognostic factor of DLBCL, as elderly patients are not capable to received standard treatment, the prognosis of elderly patients is poor especially those aged over 80 years. In this study,we aimed to investigate the safety and efficacy of the combination of lenalidomide and rituximab in elderly patients aged ≥ 80 years with untreated DLBCL.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Age Over 80 Years | — | UNRESOLVED | — |
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide combined with rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lenalidomide combined with rituximab
- description
- Rituximab 375 mg/m2 i.v d1 q28d； Lenalidomide 10mg Po. d1-21 q28d. After 6 cycles, patients obtained CR or PR will continue with Lenalidomide maintenance till the 24th month.
- interventionNames
- Drug: lenalidomide combined with rituximab
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 24 months
- description
- Overall response rate
Secondary outcomes (3)
- measure
- CR
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age≧80 years ; 2. ECOG score 0-2； 3. untreated with pathologically confirmed CD20+ DLBCL ; 4. expected life expectancy of ≥ 12 weeks; 5. capable of swallowing tablets; 6. GFR(by Cockcroft- Gault)≥30 ml/min; 7. can sign written informed consent to participate in the study. Exclusion Criteria: 1. with CNS involvement; 2. with other malignancy (not including adequate-treated non-melanoma cutaneum carcinoma); patients with other cancer but disease-free for ≥5 years can enter this study; 3. with ≥ grade 2 peripheral neurophathy; 4. with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks; 5. received live vaccine within 28 days.; 6. HIV-positive; 7. thrombosis ; 8. GFR\<30 mL/min; 9. other conditions not suitable for rituximab or lenalidomide application.
References
Publications (0)
Data not yet available