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

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Rituximab

Criteria

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.