Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Lenalidomide
* Drug: Cyclophosphamide
* Drug: Doxorubicin
* Drug: Vincristine
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed PTCL, NOS, AITL, ALK- ALCL, phase III-IV ALK+ ALCL, EATL according to WHO 2016 criteria. ECOG PS 0-2 Age 18-70 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. 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: Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons Patients known to have varicella or herpes zoster virus infection Previous exposure to any anti-tumor therapy 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 History of DVT or PE within past 12 months 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 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 CNS or meningeal involvement Known sensitivity or allergy to investigational product Major surgery within three weeks Patients receiving organ transplantation Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer Presence of Grade III nervous toxicity within past two weeks Active and severe infectious diseases Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment In any conditions which investigator considered ineligible for this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lenalidomide+CHOP<br> | Drug: Lenalidomide<br>* Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1 d10# 21days a cycle<br>Drug: Cyclophosphamide<br>* Cyclophosphamide 750 mg/m2 d1<br>Drug: Doxorubicin<br>* Doxorubicin 50 mg/m2 d1<br>Drug: Vincristine<br>* Vincristine 1.4mg/m2 (maximum 2mg) d1<br>Drug: Prednisolone<br>* Prednisolone 60mg/m2 d1-5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerated dose and dose limited toxicity |  | At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days) | 
| Overall response rate | overall response rate after treated by lenalidomide-CHOP regimen | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive free survival | from date of inclusion to date of progression, relapse, or death from any cause | 2 years | 
| Overall survival | from the date of inclusion to date of death, irrespective of cause | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTCL, lenalidomide, untreated, CHOP