Clinical trial · Interventional
Ibrutinib Combined With Rituximab for Treatment of Relapsed Refractory MYD88 and CD79A/B (or CD79B Alone) DLBCL Who Have Received at Least Two Prior Therapies
Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Ibrutinib Combined With Rituximab for Treatment of Relapsed Refractory MYD88 and CD79A/B (or CD79B Alone) DLBCL Who Have Received at Least Two Prior Therapies
NCT04994626CI-TRIAL-00053134unknownPhase 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)
The purpose of this study is to evaluate the efficacy and safety of Ibrutinib Combined With Rituximab in Relapsed Refractory MYD88 and CD79A/B (or CD79B Alone) DLBCL Who Have Received at Least Two Prior Therapies.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD79A Gene Mutation | — | UNRESOLVED | — |
| CD79B Gene Mutation | — | UNRESOLVED | — |
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| MYD88 Gene Mutation | — | UNRESOLVED | — |
| Refractory Lymphoma | Lymphoma | CURATED_BROADER | 0.78 |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib Combined With Rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ibrutinib Combined With Rituximab
- description
- Induction therapy: Ibrutinib 560mg administered oral once a day of each 21-day cycle for 6 cycles. Rituximab 375mg/m² administered intravenously (IV) on Day 1 of each 21-day cycle for 6 cycles. Maintenance therapy: Ibrutinib 560mg administered oral once a day of each 56-day cycle for 6 cycles. Rituximab 375mg/m² administered intravenously (IV) on Day 1 of each 56-day cycle for 6 cycles.
- interventionNames
- Drug: Ibrutinib Combined With Rituximab
Primary outcomes (1)
- measure
- Objective Response Rate(ORR)
- timeFrame
- 24 months after the last patient's enrollment
- description
- The ORR includes complete response and partial response. The treatment response assessments are as follows: Evaluation of treatment response are performed every 2 cycles followed the International Lymphoma Collaborative Group guidelines.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants must be able to understand and be willing to sign a written informed consent document; 2. Men and woman who are at least 18 years of age on the day of consenting to the study; 3. According to the WHO 2016 classification criteria, pathologically confirmed CD20+diffuse large B-cell lymphoma; 4. Patients with MYD88 and CD79A/B mutations or CD79B alone; 5. Relapse or progression after treatment with at least two prior therapies; 6. There is at least one measurable lesion, defined as a two-path measurable, intraductal lesion short neck \>1.5cm, extranodal lesion short diameter \>1.0cm; 7. Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 8. Blood routine examination meets the following criteria: Neutrophil count ≥ 1.0 x 109 / L; Platelet ≥ 75 x 109 / L; Hemoglobin ≥ 10.0 g / dL; 9. The main organ function meets the following criteria: Aspartate aminotransferase and alanine aminotransferase ≤ 2.0 times the upper limit of normal value; Bilirubin ≤ 2.0 mg / dL; Creatinine clearance rate ≥ 60 mL / min; 10. Must agree to effective contraception Exclusion Criteria: 1. Transformed diffuse large B-cell lymphoma; 2. HBV DNA positive or HCV RNA positive; 3. Patient is known to have an uncontrolled active systemic infection; 4. Left ventricular ejection fraction \< 40%; 5. Previous autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, dry syndrome, ankylosing spondylitis, etc; 6. Immunosuppressive drugs are being or have been used in the past; 7. Known hypersensitivity to the study drug or any of its excipients; 8. There are other active malignant tumors that may interfere with this study requiring treatment; 9. Known history of human immunodeficiency virus (HIV) infection; 10. Previous autologous stem cell transplantation or allogeneic hematopoietic stem cell transplantation; 11. The investigator judges that the patient has other inappropriate circumstances.
References
Publications (0)
Data not yet available
No reference posted for this study.