Actively Recruiting
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Led by National Cancer Institute (NCI) · Updated on 2026-04-20
155
Participants Needed
1
Research Sites
511 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed B-cell lymphoma as verified by the Laboratory of Pathology, NCI
- For phase 1b: Includes aggressive B-cell lymphoma (DLBCL, Burkitt lymphoma, high-grade B-cell lymphoma) and indolent B-cell lymphoma excluding CLL/SLL
- For phase 2: Relapsed or refractory DLBCL, follicular lymphoma, and untreated or relapsed/refractory mantle cell lymphoma
- Relapsed or refractory disease after at least one prior treatment regimen
- Measurable or evaluable lymphoma by clinical exam, lab tests, or imaging
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Adequate organ and marrow function unless due to lymphoma
- Agreement to use effective contraception if of childbearing potential or male partner
- Willingness and ability to sign informed consent
You will not qualify if you...
- Currently receiving other investigational agents
- Chemotherapy, radiation, or anti-cancer antibodies within 2 weeks prior to study drug
- Radio- or toxin-immunoconjugates within 10 weeks prior to study drug
- Previous treatment with more than one study drug (venetoclax, ibrutinib, or Revlimid), excluding prednisone or anti-CD20 antibody
- Recent allogeneic stem cell transplant or active graft-versus-host disease
- Not recovered from prior treatment side effects except alopecia
- Use of warfarin or strong CYP3A inhibitors/inducers within 7 days before treatment
- Uncontrolled heart failure, unstable angina, arrhythmia, thyroid disease
- Active infections including recent severe infections
- Active liver disease or viral hepatitis unless controlled
- Malabsorption or conditions preventing oral drug intake
- Psychiatric or social conditions limiting compliance
- Pregnancy or intent to become pregnant during the study
- HIV positive status
- Active tumor lysis syndrome
- Recent major surgery within 6 weeks
- Other active malignancies affecting participation
- Known allergies to study drugs or related compounds
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCIMO Referral Office
CONTACT
C
Christopher J Melani, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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