Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

  • STATUS
    Recruiting
  • days left to enroll
    9
  • participants needed
    91
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
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Updated on 19 February 2024
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lenalidomide
peripheral t-cell lymphoma
anaplastic large cell lymphoma

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.

Details
Condition Peripheral T-Cell Lymphoma, Enteropathy-Associated T-Cell Lymphoma, AITL, ALK- ALCL, Phase III-IV ALK+ ALCL
Age 18years - 70years
Treatment Cyclophosphamide, Lenalidomide, Vincristine, Doxorubicin, Prednisolone
Clinical Study IdentifierNCT04423926
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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 1.5109/L or platelet count less than 75109/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
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