Status:
UNKNOWN
Lenalidomide in Combination With CHOP in Patients With Untreated PTCL
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
PTCL, NOS
AITL
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04423926
Start Date
June 10 2020
End Date
December 31 2024
Last Update
June 16 2020
Active Locations (1)
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1
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China, 210029