R2-CHOP in Untreated DEL-DLBCL：An Open-lable，Multicenter，Phase II Study

Sponsor
Sun Yat-sen University
Study ID
NCT04842487
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To assess the efficacy and safety of lenalidomide combined with rituximab, vincristine, doxorubicin, cyclophosphamide, and prednisone (r2-chop) in the initial treatment of DEL-DLBCL. The primary endpoint is the complete response rate, and the second endpoints are survival time (OS and PFS) and overall response rate.

Key Dates

Start date
Apr 10, 2021
Status verified
Jun 2020
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023

Study Design

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

Arms

  • Experimental: Treatment arm
    1. Lenalidomide：25mg po QN,D1-10 2. Rituximab: 375mg/m2, ivdrip, D1 3. CTX: 750mg/m2, iv or ivdrip, D1 4. THP: 50mg/m2, iv or ivdrip, D1 5. VCR： 1.4 mg/m2 , iv（max：2mg）, D1 6. Pred: 60mg/m2, po, D1-5

Primary Outcome Measure

Complete response rate [ Time Frame: Up to 3 years ]

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