Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    91
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Send
Updated on 19 February 2024
See if I qualify
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 18-70 years
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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

lenalidomide
peripheral t-cell lymphoma
anaplastic large cell lymphoma

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.