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

NCT04842487 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-04-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

R2-CHOP(Lenalidomide,Rituximab,cyclophosphamide，hydroxyldaunorubicin，Vincristine，Prednisone）)

Lenalidomide：25mg po QN,d1-10 Rituximab: 375mg/m2, ivdrip, d1 Cyclophosphamide: 750mg/m2, iv or ivdrip, d1 Hydroxyldaunorubicin: 50mg/m2, iv or ivdrip, d1 Vincristine： 1.4 mg/m2 , iv（max：2mg）, d1 Prednisone: 60mg/m2, po, d1-5 every 3 weeks was a course of treatment

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-10
Primary Completion
2023-12-30
Completion
2023-12-30

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Entities

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 NCT04842487 on ClinicalTrials.gov