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).
To study the safety of ViPOR for people with B-cell lymphoma.
People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after
Participants will be screened with:
Blood, urine, and heart tests
Tissue sample from previous procedure
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.
Combination chemotherapy with Rituximab has been the mainstay of treatment for CD20-positive
Significant advances have been made in curing aggressive B-cell lymphomas with
chemoimmunotherapy but indolent lymphomas and relapsed/refractory aggressive lymphomas remain
mostly incurable with chemotherapy alone
Targeted therapies aimed at disrupting key survival pathways in lymphoid malignancies are
emerging and showing significant activity in NHL in both the relapsed and first-line settings
Mechanistically-based combinations of targeted agents are likely to benefit patients who
cannot tolerate or who relapse after or are refractory to standard chemoimmunotherapy
ViPOR targets major survival pathways in B-cell lymphomas including BCL-2 (apoptosis); BTK
(B-cell receptor signaling and NFKB); Cereblon (NFKB) and CD20.
Phase 1b: To determine the maximum tolerated dose (MTD) and the safety and toxicity profile
of the combination of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab and Revlimid (ViPOR) in
relapsed/refractory B-cell malignancies
Phase 2: To determine the overall response rate (ORR) and complete response (CR) rate of
ViPOR in relapsed/refractory B-cell malignancies
Women and men greater than or equal 18 years of age
ECOG performance status of less than or equal to 2 [JS(
Histologically or cytologically confirmed relapsed and/or refractory B-cell lymphoma,
excluding CLL/SLL. NOTE: untreated and relapsed and/or refraactory MCL are included in the
phase 2 MCL expansion.
Adequate organ function unless dysfunction secondary to lymphoma effect
Open-label, single-center, non-randomized phase 1b/2 study
Phase 1b: Standard 3 + 3 design will be used to determine the MTD of dose-escalated
venetoclax with fixed dose ibrutinib, prednisone, obinutuzumab and Revlimid (ViPOR) in
relapsed/refractory B-cell malignancies
Phase 2: Expansion cohorts of aggressive and indolent non-MCL patients and MCL patients will
be treated at the MTD to determine the ORR and CR rate in these subtypes.
Maximum 6 cycles of combination targeted therapy every 21 days
To explore all dose levels in both non-MCL and MCL patient cohorts in the phase 1b study, and
to assess the ORR and CR rate in aggressive and indolent non-MCL and MCL patient cohorts in a
phase 2 dose expansion at the MTD, the accrual ceiling will be set at 130 patients.
Lymphoma, Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, Burkitt Lymphoma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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