Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System

Conditions

• Aggressive B-cell Lymphoma With Secondary Involvement of the CNS
• Primary Diffuse Large B-cell Lymphoma of the Central Nervous System (CNS)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Obinutuzumab — DRUG
  Obinutuzumab 1000 mg IV (intravenous) days 1 and 2 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
• Prednisone — DRUG
  Prednisone 100 mg PO (by mouth) daily days 1-7 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
• Lenalidomide — DRUG
  Lenalidomide 10 or 15 mg PO (by mouth) on days 1-14 for 1 cycle (21 days); followed by Lenalidomide 10 or 15 mg PO daily days 1-14 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
• Venetoclax — DRUG
  Venetoclax 800 mg PO (by mouth) on days 1-14 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
• Ibrutinib — DRUG
  Ibrutinib 560 mg PO (by mouth) daily days 1-14 for a maximum of 6 cycles every 21 days (each cycle is 21 days)
• Acetaminophen — DRUG
  650 mg by mouth (PO) daily on days 1 and 2 approximately 30-60 minutes prior to Obinutuzumab infusion.
• Diphenhydramine — DRUG
  50mg by mouth (PO) daily on days 1 and 2 approximately 30-60 minutes prior to Obinutuzumab infusion.
• Peg-filgrastim — OTHER
  6 mg subcutaneous once on day 8 only.
• CT Scan (chest, abdomen, and pelvis) — DIAGNOSTIC_TEST
  To assess sites of disease.
• MRI — DIAGNOSTIC_TEST
  If clinically indicated.
• 18f-FDG-PET — DIAGNOSTIC_TEST
  If clinically indicated.
• PET — DIAGNOSTIC_TEST
  If clinically indicated.
• Lumbar puncture/Ommaya tap — DIAGNOSTIC_TEST
  If clinically indicated.
• Bone marrow aspiration/biopsy — DIAGNOSTIC_TEST
  If clinically indicated.
• EKG — COMBINATION_PRODUCT
  To determine eligibility.

Study Details

Background: People with primary diffuse large B-cell lymphoma of the central nervous system (CNS) and aggressive B-cell lymphomas with secondary CNS involvement have a poor prognosis. Researchers want to learn if a combination of drugs can help. Objective: To learn if it is safe to give people with these cancers Nivolumab (VIPOR-Nivo). Eligibility: People aged 18 and older with B-cell lymphoma in the CNS that does not respond to treatment, response to treatment does not last long, or there is no standard treatment. Design: Participants will be screened with: Health history Physical exam Blood, urine, and heart tests Computed tomography (CT), fludeoxyglucose F18 (FDG) positron emission tomography (PET), and magnetic resonance imaging (MRI) scans. Participants will lie in scanners that take pictures of the body. For some scans, a contrast or chemical agent will be injected into a vein. Lumbar puncture or Ommaya tap. Participants will have a small needle inserted into their lower back or scalp to obtain fluid. Possible tumor biopsy. Participants will have a needle inserted into a tumor to take a sample. Participants will get the study drugs in 21-day cycles. They may have up to 6 treatment cycles. They will take some drugs by infusion into a vein and some drugs by mouth. Participants will get counseling at least every 28 days on the risks of lenalidomide. Participants will have visits throughout the study. Visits may include repeats of the screening tests. They may also include: Bone marrow biopsy. Participants will have a needle inserted into their hipbone to remove marrow. Saliva samples and cheek swabs Participants will have periodic follow-up visits for about 10 years.

Key Dates

Start date

Apr 19, 2022

Status verified

Dec 2025

Primary completion

Jun 1, 2024

Completion

Jun 1, 2029

Study Design

Enrollment

14 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 1: VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide)
  VIPOR (venetoclax, ibrutinib, prednisone, obinutuzumab, lenalidomide) in 21-day cycles for up to 6 cycles

Primary Outcome Measure

Proportion of Participants Who Completed at Least 2 Cycles of VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) Therapy Without Stopping Due to Toxicity [ Time Frame: After 2 Cycles (each cycle is 21 days) ]

Locations (1)

Find similar trials in Bethesda, MD