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

NCT04432714 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-06-16

No results posted yet for this study

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.

Conditions

  • DLBCL
  • Untreated
  • MYC Gene Rearrangement

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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Wei Xu, M.D., Ph.D · The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT04432714 on ClinicalTrials.gov