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A Phase II Study of Zanubrutinib, Lenalidomide Plus R-CHOP as the First-line Treatment for Diffused Large B-cell Lymphoma

NCT05200312 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-03-11

No results posted yet for this study

Summary

This study is a multi-center, open-label, single-arm, non-randomized phase II clinical study in order to evaluate the safety and efficacy of zanubrutinib, lenalidomide plus R-CHOP (ZR2-CHOP) as the first-line therapy for treatment-naive high-risk diffuse large B-cell lymphoma patients.

Conditions

Interventions

DRUG

Zanubrutinib

160 mg capsules administered by mouth twice daily (21-day cycles).

DRUG

Lenalidomide

25 mg capsules administered by mouth once daily on Day 1 to Day 10 of each cycle (21-day cycles)

DRUG

Rituximab

375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Cyclophosphamide

750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Doxorubicin

50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Vincristine

1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Prednisone (or equivalent)

40 mg/m2 capsules administered by mouth once daily on Day 1 to Day 5 of each cycle

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Jianyong Li, Phd, MD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-02-01
Completion
2025-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05200312 on ClinicalTrials.gov