NCT04423926

Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The prognosis of PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that single agent lenalidomide showed promising therapeutic activity in patients with relapsed or refractory PTCL. The investigators therefore design this phase II study to investigate the safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive PTCL.

Conditions

• PTCL, NOS
• AITL
• ALK- ALCL
• Phase III-IV ALK+ ALCL
• EATL

Interventions

Type	Name	Description
DRUG	Lenalidomide	Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle
DRUG	Cyclophosphamide	Cyclophosphamide 750 mg/m2 d1
DRUG	Doxorubicin	Doxorubicin 50 mg/m2 d1
DRUG	Vincristine	Vincristine 1.4mg/m2 (maximum 2mg) d1
DRUG	Prednisolone	Prednisolone 60mg/m2 d1-5

Timeline

• Start date: 2020-06-10
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2020-06-09
• Last updated: 2020-06-16

Locations

1 site across 1 country: China