AITL, ALK- ALCL, EATL, Phase III-IV ALK+ ALCL, PTCL, NOS
Conditions
Keywords
PTCL, lenalidomide, untreated, CHOP
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. 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.
Interventions
DRUGLenalidomide
Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\ d10# 21days a cycle
DRUGCyclophosphamide
Cyclophosphamide 750 mg/m2 d1
DRUGDoxorubicin
Doxorubicin 50 mg/m2 d1
DRUGVincristine
Vincristine 1.4mg/m2 (maximum 2mg) d1
DRUGPrednisolone
Prednisolone 60mg/m2 d1-5
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 11. Major surgery within three weeks 12. Patients receiving organ transplantation 13. 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 14. Presence of Grade III nervous toxicity within past two weeks 15. Active and severe infectious diseases 16. Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment 17. In any conditions which investigator considered ineligible for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months | overall response rate after treated by lenalidomide-CHOP regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progressive free survival | 2 years | from date of inclusion to date of progression, relapse, or death from any cause |
| Overall survival | 2 years | from the date of inclusion to date of death, irrespective of cause |
Countries
China
Contacts
Primary ContactLi Wang, M.D., Ph.D.
Backup ContactWei Xu, M.D., Ph.D.
Outcome results
None listed