Background:
B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR).
Objective:
To study the safety of ViPOR for people with B-cell lymphoma.
Eligibility:
People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after treatment
Design:
Participants will be screened with:
* Medical history * Physical exam * Blood, urine, and heart tests * Tissue sample from previous procedure * Imaging scans * Registration for counseling on the risks of lenalidomide. They must get counseling at least every 28 days.
Participants will have a bone marrow aspiration before treatment.
Participants may have tumor samples taken.
Participants will get ViPOR in 21-day cycles. For up to 6 cycles:
* Participants will get one drug by IV on days 1 and 2. * Participants will take the other four drugs by mouth on most days. After their first dose of venetoclax, they will stay in the clinic for at least 8 hours and return the next day for monitoring. They may be admitted for more drugs or monitoring.
Participants will keep a drug diary.
Participants will have a physical exam and blood and urine tests at least once per cycle. They will have scans 4 times over 6 cycles.
Participants will have a visit about 1 month after their last dose of study drug. They will then have visits every few months for 3 years, and once a year for years 4 and 5. Visits include a physical exam, blood tests, and scans.
Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as High-grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangement(s).
CLL/SLL is excluded given alternative dosing of FDA-approved venetoclax for relapsed 17p CLL and increased risk of TLS with CLL/SLL compared to other non-Hodgkin lymphomas.
NOTE: Patients with known active CNS lymphoma are not eligible.
Relapsed and/or refractory DLBCL and subtypes, including transformed lymphoma as well as High grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangement(s).
Patients who are actively receiving any other investigational agents.
Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug
Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug
Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment
National Cancer Institute (NCI)
Lead sponsor