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Lenalidomide in Combination With CHOP in Patients With Untreated PTCL | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

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

NCT04423926•The First Affiliated Hospital with Nanjing Medical University

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically confirmed PTCL, NOS, AITL, ALK- ALCL, phase III-IV ALK+ ALCL, EATL according to WHO 2016 criteria.
•2. ECOG PS 0-2
•3. Age 18-70 years old
•4. Expected survival ≥ 12 weeks
•5. A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)
•6. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
•7. Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures

Exclusion Criteria

•1. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
•2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
•3. Patients known to have varicella or herpes zoster virus infection
•4. Previous exposure to any anti-tumor therapy
•5. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related to the lymphoma
•6. History of DVT or PE within past 12 months
•7. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration
•8. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia
•9. CNS or meningeal involvement
•10. Known sensitivity or allergy to investigational product
+7 more criteria

Locations (1)

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Nanjing, Jiangsu, China

Key Dates

Start Date

June 10, 2020

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2024

Last Updated

June 16, 2020

Enrollment

ESTIMATED participants

Conditions

PTCL, NOSAITLALK- ALCLPhase III-IV ALK+ ALCLEATL

Interventions

Lenalidomide

DRUG

Cyclophosphamide

DRUG

Doxorubicin

DRUG

Vincristine

DRUG

Prednisolone

DRUG

Contacts

Li Wang, M.D., Ph.D.

CONTACT

86 25 68306034 lilyw7878@163.com

Wei Xu, M.D., Ph.D.

CONTACT

86 25 68306034 xuwei10000@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

Inclusion Criteria

Exclusion Criteria

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