Clinical trial · Interventional
Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Efficacy and Safety of Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
NCT04432402CI-TRIAL-00045533unknownN/AClinicalTrials.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)
The purpose of this study is to investigate efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of elderly patients with 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide in Combination With R-GemOx
- description
- Lenalidomide 10mg、15mg、20mg、25mg qd PO d1-7 Rituximab 375mg/m2 ivd d0 Gemcitabine 1g/m2 ivd d1 Oxaliplatin 100mg/m2 ivd d1 every14 days as a cycle
- interventionNames
- Drug: Lenalidomide
Primary outcomes (3)
- measure
- Maximum tolerated dose
- timeFrame
- at the end of the first cycle of R2-GemOx (each cycle is 14 days)
- description
- Maximum tolerated dose
- measure
- Dose limiting toxicity
- timeFrame
- 28 days
- description
- Dose limiting toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. The histopathologic diagnosis was DLBCL (except primary mediastinal large B cell lymphoma, primary central lymphoma, HIV related lymphoma). 2. Age older than 70 years or older than 60 years with Eastern Cooperative Oncology Group(ECOG) performance status(PS) ≥ 2; 3. Expected survival ≥ 12 weeks; 4. At least a measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm); 5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements; 6. All patients must agree to take effective contraceptive measures during the trial measures Exclusion Criteria: 1. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons 2. Patients known to have varicella or herpes zoster virus infection 3. Previous exposure to any anti-tumor therapy 4. Poor hepatic and/or renal function, unless these abnormalities were related to the lymphoma 5. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration 6. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within past 12 months 7. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia 8. Central nervous system (CNS) or meningeal involvement 9. Known sensitivity or allergy to investigational product 10. Major surgery within three weeks 11. Patients receiving organ transplantation 12. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer 13. Presence of Grade III nervous toxicity within past two weeks 14. Active and severe infectious diseases 15. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment 16. In any conditions which investigator considered ineligible for this study. 17. Histologic transformation
References
Publications (0)
Data not yet available
No reference posted for this study.