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

Who is this study for? Adult patients with diffuse large B-cell lymphoma
What treatments are being studied? Lenalidomide+R-DA-EPOCH
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma.

• ECOG PS 0-2

• Age 18-60 years old

• Expected survival ≥ 12 weeks

• A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)

• Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Locations
Other Locations
China
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
RECRUITING
Nanjing
Contact Information
Primary
Li Wang, M.D., Ph.D
lilyw7878@163.com
86 25 68306034
Backup
Wei Xu, M.D., Ph.D
xuwei10000@hotmail.com
86 25 68306034
Time Frame
Start Date: 2020-06-09
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 81
Treatments
Experimental: R2-DA-EPOCH
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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