Aggressive B-cell lymphomas can be cured but people with disease that resists treatment or
that returns after treatment have poor outcomes with standard therapies. Indolent B-cell
lymphomas are generally incurable with standard therapy and treatment is aimed at controlling
symptoms and achieving a durable remissions. Researchers want to see if a combination of
drugs can help patients with both aggressive and indolent B-cell lymphomas.
To learn if it is safe and effective to give polatuzumab along with venetoclax, ibrutinib,
prednisone, obinutuzumab, and lenalidomide to people with certain B-cell lymphomas.
Adults ages 18 and older with relapsed and/or refractory B-cell lymphoma who have had at
least one prior cancer treatment.
Participants will be screened with:
Assessment of how they do their daily activities
Blood and urine tests
Heart function test
Tissue biopsy (if needed)
Body imaging scans (may get a contrast agent through an intravenous (IV) catheter)
Participants will have a bone marrow aspiration and/or biopsy. A needle will be put into the
hipbone. Bone marrow will be removed.
Participants may give blood, tissue, saliva, or cheek swab samples. They may have optional
Screening tests will be repeated during the study.
Treatment will be given for up to 6 cycles. Each cycle lasts 21 days.
Participants will take venetoclax and prednisone tablets by mouth. They will take ibrutinib
and lenalidomide capsules by mouth. They will get obinutuzumab and polatuzumab by IV
infusion. They will keep a medicine diary.
Participants will visit the clinic 30 days after treatment ends. They will have follow-up
visits for 5 years. If needed, they can visit their local doctor instead. They may be
contacted by phone, mail, etc., for the rest of their life....
Combination chemotherapy with rituximab has been the mainstay of treatment for
CD20-positive B-cell lymphomas.
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 non-Hodgkin lymphoma (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-P targets major survival pathways in B-cell lymphomas including BCL-2 (apoptosis);
BTK (B-cell receptor signaling and NF-kB); Cereblon (NF-kB) and CD20 with additional
genotoxic stress from the anti-mitotic antibody-drug conjugate targeting CD79b,
To determine the maximum tolerated dose (MTD) and the safety and toxicity profile of
polatuzumab and venetoclax in combination with venetoclax, ibrutinib, prednisone,
obinutuzumab and Revlimid(SqrRoot) (lenalidomide) (ViPOR-P) in relapsed/refractory B-cell
Women and men greater than or equal to 18 years of age
ECOG performance status of less than or equal to 2
Adequate organ function unless dysfunction secondary to lymphoma
Open-label, single-center, non-randomized phase 1 study
Standard 3 + 3 design will be used to determine the MTD of polatuzumab and venetoclax in
combination with venetoclax, ibrutinib, prednisone, obinutuzumab and Revlimid
(lenalidomide) (ViPOR-P) in relapsed/refractory B-cell lymphomas
A small expansion cohort will be treated at the MTD in a further analysis of safety and
Maximum 6 cycles of combination targeted therapy every 21 days.
To explore all dose levels in the phase 1 study and to allow for the possibility of a
few screen failures and inevaluable subjects, the accrual ceiling will be set at 32
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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