Clinical trial · Interventional
Study Evaluating the Safety and Efficacy of iR2 in Untreated and Unfit Elderly Patients With DLBCL
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of iR2 (Ibrutinib，Lenalidomide, Rituximab）in Untreated and Unfit Elderly Patients With Diffuse Large B-cell Lymphoma
NCT03949062CI-TRIAL-00050106unknownPhase 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 single-arm, open-label phase 2 study of iR2 in the treatment of unfit and elderly patients with untreated 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- iR2
- description
- Participants received six 21-day cycles of ibrutinib, lenalidomide, and rituximab (iR2) treatment (21-day cycles).
- interventionNames
- Drug: Ibrutinib
- Drug: Lenalidomide
- Drug: Rituximab
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- At the end of Cycle 6 (each cycle is 21 days)
- description
- Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Secondary outcomes (4)
- measure
- Overall response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed diffuse large B cell lymphoma, treatment naive 2. Age \> 75 years 3. Ineligible for standard chemotherapy 4. Must has measurable lesion in CT or PET-CT prior to treatment 5. At least 3 months life expectation 6. Informed consented 7. No previous use of study drug Exclusion Criteria: 1. Has accepted Chemotherapy before 2. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease 3. Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/L ;Platelet\<80\*10\^9/L; ALT or AST \>2\*ULN; AKP or bilirubin \>1.5\*ULN ;Creatinine\>1.5\*ULN 4. Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation 5. HIV infection 6. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled. 7. Other uncontrollable medical condition that may that may interfere the participation of the study
References
Publications (1)
- DERIVEDXu PP, Shi ZY, Qian Y, Cheng S, Zhu Y, Jiang L, Li JF, Fang H, Huang HY, Yi HM, Ouyang BS, Wang L, Zhao WL. Ibrutinib, rituximab, and lenalidomide in unfit or frail patients aged 75 years or older with de novo diffuse large B-cell lymphoma: a phase 2, single-arm study. Lancet Healthy Longev. 2022 Jul;3(7):e481-e490. doi: 10.1016/S2666-7568(22)00123-4. PMID 36102758