A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)

Part of paid clinical trials in New York, New York.

Sponsor
Hoffmann-La Roche
Study ID
NCT04790903
Phase
PHASE1
Status
Terminated

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Participants will self-administer Venetoclax, as described in the Arm Descriptions.
  • Polatuzumab Vedotin — DRUG
    Participants will receive Polatuzumab Vedotin at a dose of 1.8 mg/kg by intravenous (IV) infusion on Day 1 of Cycles 1-6.
  • Rituximab — DRUG
    Participants will receive Rituximab at a dose of 375 mg/m\^2 by IV infusion on Day 1 of Cycles 1-6.
  • Cyclophosphamide — DRUG
    Participants will receive Cyclophosphamide at a dose of 750 mg/m\^2 by IV infusion or bolus on Day 1 of Cycles 1-6.
  • Doxorubicin — DRUG
    Participants will receive Doxorubicin at a dose of 50 mg/m\^2 by IV infusion or bolus on Day 1 of Cycles 1-6.
  • Prednisone — DRUG
    Participants will receive Prednisone orally (PO) at a dose of 100 mg/day on Days 1-5 of Cycles 1-6.

Study Details

This Phase Ib, open-label, multicenter study evaluates the safety, efficacy, and pharmacokinetics of venetoclax in combination with Pola + R-CHP in previously untreated participants with BCL-2 IHC-positive DLBCL. Approximately 50 participants will be enrolled in this study in five consecutive cohorts each consisting of approximately 10 participants.

Key Dates

Start date
Jul 2, 2021
Status verified
Jul 2024
Primary completion
May 21, 2024
Completion
May 21, 2024

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax (Schedule A)
    Participants enrolled in dosing Schedule A will receive a total of six 21-day cycles of venetoclax treatment for 5 days in combination with Polatuzumab Vedotin + R-CHP (Rituximab, Cyclophosphamide, Doxorubicin and Prednisone) as described below: Schedule A: Participants will self-administer Venetoclax orally (PO) once daily (QD) at a dose of 800 mg for 5 consecutive days as follows: Cycle 1: 5 consecutive days of dosing on Days 4-8. Cycles 2-6: 5 consecutive days of dosing on Days 1-5.
  • Experimental: Venetoclax (Schedule B)
    Participants enrolled in dosing Schedule B will receive a total of six 21-day cycles of venetoclax treatment for 10 days in combination with Polatuzumab Vedotin + R-CHP as described below: Schedule B: Participants will self-administer Venetoclax orally (PO) once daily (QD) at a dose of 800 mg for 10 consecutive days as follows: Cycle 1: 10 consecutive days of dosing on Days 4-10. Cycles 2-6: 10 consecutive days of dosing on Days 1-10.

Primary Outcome Measure

Percentage of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 Day 1 up to but not including Cycle 3 Day 1 (Cycle length = 21 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical PharmacyNew YorkNew York10016-
SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLCNashvilleTennessee37203-

Find similar trials in New York, NY

By research site
Memorial Sloan-Kettering Cancer Center· New York, NYNYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy· New York, NYSARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC· Nashville, TN

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