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Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

NCT04423926 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2020-06-16

No results posted yet for this study

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

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

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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04423926 on ClinicalTrials.gov