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NCT04739813

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
Primary completion
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Record History

The 50 most recent of 234 versions: 10 with changes below, 40 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Nov 12, 2026 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 155 words
    • Enrollment increased: 34 → 49 participants
    • Study completion moved earlier from Jun 18, 2031 to May 7, 2031
    • Interventions modified
    • Secondary endpoints revised (6)
    • Study description expanded, about 62 words
  2. Enrollment reduced: 55 → 34 participants
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from Jun 18, 2026 to May 7, 2026
    • Site details revised
    v233
  3. Primary completion pushed from Apr 4, 2026 to Jun 18, 2026
    • Study completion pushed from Apr 4, 2031 to Jun 18, 2031
    v232
  4. Primary completion date: Oct 29, 2025 to Apr 4, 2026
    • Study completion date: Oct 29, 2030 to Apr 4, 2031
    v228
  5. Eligibility criteria shortened, about 61 words
    • Study description shortened, about 10 words
    v224
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Jul 15, 2024 to Oct 29, 2025
    • Study completion date: Jul 15, 2029 to Oct 29, 2030
    v217
  2. Primary completion date: Jul 15, 2023 to Jul 15, 2024
    • Primary endpoints: 1 to 2
    • Study completion date: Jul 15, 2028 to Jul 15, 2029
    v206
  3. Eligibility criteria expanded, about 26 words
    • Study description expanded, about 68 words
    v204
  4. Enrollment target: 32 to 55v201
  5. Primary completion date: Apr 1, 2023 to Jul 15, 2023
    • Study completion date: Sep 1, 2027 to Jul 15, 2028
    v198
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Dose Escalation: Number of Grade 3, 4 and/or 5 Dose-limiting (DLT) Adverse Events at Each Dose Level With Type
Timeframe: 21 days
Maximum Tolerated Dose (MTD) of Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma
Timeframe: 21 Days (Cycle 1)
Maximum Tolerated Dose (MTD) of Venetoclax in Relapsed/Refractory B-cell Lymphoma
Timeframe: 21 Days (Cycle 1)

Secondary (6)

Overall Response Rate (ORR)
Duration of Response
Progression-free Survival (PFS)
Event-free Survival (EFS)
Overall Survival (OS)
Show 1 moreShow less
Complete Response Rate in Non-Germinal Center B-cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL) Treated at the Maximum Tolerated Dose (MTD)

Arms and interventions

Arm 1: Dose Escalation with Venetoclax,Ibrutinib,Prednisone,Obinutuzumab,Lenalidomide,PolatuzumabExperimental

Venetoclax by mouth (PO) at escalating doses (2 dose levels) on days 2-14, ibrutinib (PO) 560mg on days 1-14, prednisone (PO) 100mg on days 1-7, obinutuzumab 1000mg intravenous (IV) on days 1 and 2, lenalidomide (PO) 15mg on days 1-14, and polatuzumab (IV) at escalating doses (2 dose levels) on day 2 of each 21-day cycle (maximum 6 cycles) to determine maximum tolerated dose (MTD) of polatuzumab and venetoclax.

Arm 2: Dose Expansion with Venetoclax,Ibrutinib,Prednisone,Obinutuzumab,Lenalidomide,PolatuzumabExperimental

Venetoclax by mouth (PO) at the maximum tolerated dose (MTD) days 2-14, ibrutinib (PO) 560mg on days 1-14, prednisone (PO) 100mg on days 1-7, obinutuzumab 1000mg intravenous (IV) on days 1 and 2, lenalidomide (PO) 15mg on days 1-14, and polatuzumab (IV) at the MTD of each 21-day cycle (maximum 6 cycles)

Biologicals: Obinutuzumab, Polatuzumab

Drugs: Prednisone, Revlimid, Ibrutinib, Venetoclax, Acetaminophen, Diphenhydramine, Polatuzumab

Diagnostic tests: EKG, CT, MRI, PET

Procedures: Bone marrow aspiration, Bone marrow biopsy, Tumor tissue/Biopsy

Sites

1 site in 1 country

  • National Institutes of Health Clinical CenterBethesda, Maryland, United States