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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)

NCT04790903 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-07-11

No results posted yet for this study

Summary

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.

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Interventions

DRUG

Venetoclax

Participants will self-administer Venetoclax, as described in the Arm Descriptions.

DRUG

Polatuzumab Vedotin

Participants will receive Polatuzumab Vedotin at a dose of 1.8 mg/kg by intravenous (IV) infusion on Day 1 of Cycles 1-6.

DRUG

Rituximab

Participants will receive Rituximab at a dose of 375 mg/m\^2 by IV infusion on Day 1 of Cycles 1-6.

DRUG

Cyclophosphamide

Participants will receive Cyclophosphamide at a dose of 750 mg/m\^2 by IV infusion or bolus on Day 1 of Cycles 1-6.

DRUG

Doxorubicin

Participants will receive Doxorubicin at a dose of 50 mg/m\^2 by IV infusion or bolus on Day 1 of Cycles 1-6.

DRUG

Prednisone

Participants will receive Prednisone orally (PO) at a dose of 100 mg/day on Days 1-5 of Cycles 1-6.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2024-05-21
Completion
2024-05-21
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy
  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04790903 on ClinicalTrials.gov