Zanubrutinib, Lenalidomide and Rituximab (ZR2) in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Sponsor
Ruijin Hospital
Study ID
NCT04460248
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Zanubrutinib, Lenalidomide and Rituximab (ZR2) — DRUG
    Induction therapy: The ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles. Dosage: 1. Zanubrutinib, 160 mg bid, po, day 1-21; 2. Lenalidomide, 25 mg qd, po, day 2-11; 3. Rituximab, 375 mg/m2, ivgtt, day 1. Maintenance therapy: Patients who receive complete response or partial response after induction therapy will receive lenalidomide 25 mg qd po during 1-10 days in every 21 days, for a maximum of 2 years.

Study Details

This is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) regimen in elderly treatment-naive patient with diffuse large B-cell lymphomas.

Key Dates

Start date
Aug 26, 2020
Status verified
Apr 2025
Primary completion
Feb 16, 2022
Completion
Dec 1, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zanubrutinib, Lenalidomide and Rituximab (ZR2)

Primary Outcome Measure

Complete response rate [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]

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