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RECRUITING
NCT04432714
PHASE1/PHASE2

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2020-06-09

Completion Date

2026-12-31

Last Updated

2020-06-16

Healthy Volunteers

No

Interventions

DRUG

Lenalidomide

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

DRUG

Rituximab

Rituximab 375 mg/m2,IV, d0

DRUG

Etoposide

Etoposide 50 mg/m2/day CI24h d1-d4

DRUG

Doxorubicin

Doxorubicin 10 mg/m2/day CI24h d1-d4

DRUG

Vincristine

Vincristine 0.4mg/m2/day CI24h d1-d4

DRUG

Cyclophosphamide

Cyclophosphamide 750 mg/m2/day IV d5

DRUG

Prednisone

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