NCT04432714

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-06-09
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2020-06-16
• Last updated: 2020-06-16

Locations

1 site across 1 country: China