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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

April 19, 2022

Primary Completion Date

June 1, 2024

Study Completion Date

June 1, 2029

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

Obinutuzumab

Obinutuzumab 1000 mg IV (intravenous) days 1 and 2 for a maximum of 6 cycles every 21 days (each cycle is 21 days)

DRUG

Prednisone

Prednisone 100 mg PO (by mouth) daily days 1-7 for a maximum of 6 cycles every 21 days (each cycle is 21 days)

DRUG

Lenalidomide

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)

DRUG

Venetoclax

Venetoclax 800 mg PO (by mouth) on days 1-14 for a maximum of 6 cycles every 21 days (each cycle is 21 days)

DRUG

Ibrutinib

Ibrutinib 560 mg PO (by mouth) daily days 1-14 for a maximum of 6 cycles every 21 days (each cycle is 21 days)

DRUG

Acetaminophen

650 mg by mouth (PO) daily on days 1 and 2 approximately 30-60 minutes prior to Obinutuzumab infusion.

DRUG

Diphenhydramine

50mg by mouth (PO) daily on days 1 and 2 approximately 30-60 minutes prior to Obinutuzumab infusion.

OTHER

Peg-filgrastim

6 mg subcutaneous once on day 8 only.

DIAGNOSTIC_TEST

CT Scan (chest, abdomen, and pelvis)

To assess sites of disease.

DIAGNOSTIC_TEST

MRI

If clinically indicated.

DIAGNOSTIC_TEST

18f-FDG-PET

If clinically indicated.

DIAGNOSTIC_TEST

PET

If clinically indicated.

DIAGNOSTIC_TEST

Lumbar puncture/Ommaya tap

If clinically indicated.

DIAGNOSTIC_TEST

Bone marrow aspiration/biopsy

If clinically indicated.

COMBINATION_PRODUCT

EKG

To determine eligibility.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH