Clinical trial · Interventional
R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Diffuse Large B Cell Lymphoma
A Single-arm, Multi-center, Phase II Clinical Trial of R-CHOP Combined With Lenalidomide in the First-line Treatment for Patients With Medium to High Risk/High Risk Diffuse Large B Cell Lymphoma
NCT04214626CI-TRIAL-00097473completedPhase 2ClinicalTrials.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)
This is a prospective single-arm, multi-center, phase II clinical trial to observe the efficacy and safety of R-CHOP (Rituximab-Cyclophosphamide, Epirubicin, Vincristine and Prednisone) combined with lenalidomide in the first-line treatment for patients with medium to high risk/high risk diffuse large B 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 |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-CHOP regimen Combined With Lenalidomide
- description
- Experimental: R-CHOP regimen Combined With Lenalidomide Induction Chemotherapy: Rituximab, 375mg/m2, Intravenous administration on day 0, Lenalidomide, 25mg oral administration on day 1 to 10, combined with regimen：CHOP (Cyclophosphamide, Epirubicin, Vincristine and Prednisone): repeated every 3 weeks, up to 6 cycles. Patients will exit and receive salvage treatment for the following situations: disease progression, stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops. Maintenance Treatment for patients with CR after 6 cycles: Rituximab, 375mg/m2, Intravenous administration on day 0 repeated every 3 weeks until disease progression or unacceptable toxicity develops, up to 2 cycles. PS: Methotrexate, 1g/m2, Intravenous administration on day 3 of each 3-week cycle, from 2 to 5 cycles for patients with high recurrence risk of the central nervous system.
- interventionNames
- Drug: Rituximab
- Drug: Lenalidomide
- Drug: Cyclophosphamide
- Drug: Epirubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Methotrexate
Primary outcomes (1)
- measure
- 2-year progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 to 70 years old (including 18 and 70) 2. Diagnosed as diffuse large B cell lymphoma 3. Subjects must be untreated (medium to high risk/high risk: International Prognostic Index (IPI) score 3-5 or aaIPI score 2-3/ Immunohistochemical staining of double expression (BCL2 ≥ 50% and C-MYC ≥ 40%) or P53 protein mutation positive ≥ 50%) 4. No receiving chemotherapy before enrollment 5. Having at least one measurable lesions 6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 7. Life expectancy no less than 3 months 8. enough main organ function 9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 10. Agreeing to sign the written informed consents Exclusion Criteria: 1. Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike 2. Diagnosed as grey-zone lymphoma 3. Diagnosed as central nervous system lymphoma 4. Diagnosed as primary mediastinal large B-cell lymphoma 5. Diagnosed as CD20 negative diffuse large B-cell lymphoma 6. Other malignant tumor history or active malignant tumor need be treated 7. Serious surgery and trauma less than two weeks 8. Systemic therapy for serious acute/chronic infection 9. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 10. Vaccination with live attenuated vaccine less than 4 weeks 11. HIV-positive, AIDS patients and untreated active hepatitis 12. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months 13. Patients with a history of mental illness 14. Researchers determine unsuited to participate in this trial
References
Publications (0)
Data not yet available
No reference posted for this study.