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

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES · Aug 3, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) that has not responded to previous therapies. Specifically, the study will test the combination of two drugs, Ibrutinib and Rituximab, in patients who have certain genetic mutations (MYD88 and CD79A/B) and who have already undergone at least two other treatments without success. The trial aims to see how effective and safe this new combination is for treating these patients.

To be eligible for this study, participants need to be at least 18 years old and diagnosed with DLBCL that meets specific criteria. They must also have measurable cancer lesions and acceptable blood test results. However, certain conditions, such as active infections or a history of autoimmune diseases, may exclude someone from participating. If you qualify and choose to join, you can expect to receive this combination treatment and will be closely monitored by the research team for any side effects or changes in your condition. Remember, this trial is not yet recruiting participants, so there will be more updates in the future.

Gender

ALL

Eligibility 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.