RecruitingPhase 1Phase 2NCT04432714

Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement

A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

81 participants

Start Date

Jun 9, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The prognosis of DLBCL with MYC rearrangement is dismal. Previous study showed that lenalidomide in combination with R-CHOP showed promising therapeutic activity and that R-DA EPOCH was superior compared to R-CHOP regimen in this cohort of patients. The investigators therefore design this phase I/II study to investigate the safety and efficacy of lenalidomide in combination with R-DA EPOCH in patients with untreated MYC-rearranged DLBCL.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclophosphamide, a drug called Doxorubicin, and others for people with dlbcl, myc gene rearrangement, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenalidomide

Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle

DRUGRituximab

Rituximab 375 mg/m2,IV, d0

DRUGEtoposide

Etoposide 50 mg/m2/day CI24h d1-d4

DRUGDoxorubicin

Doxorubicin 10 mg/m2/day CI24h d1-d4

DRUGVincristine

Vincristine 0.4mg/m2/day CI24h d1-d4

DRUGCyclophosphamide

Cyclophosphamide 750 mg/m2/day IV d5

DRUGPrednisone

Prednisone 60 mg/m2/bid oral or IV d1-d5


Locations(1)

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Nanjing, Jiangsu, China

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NCT04432714


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