PD-1 Antibody Chidamide Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Sep 1, 2021
  • participants needed
    100
  • sponsor
    Mingzhi Zhang
Updated on 24 January 2021
measurable disease
chidamide
lenalidomide
t-cell lymphoma
peripheral t-cell lymphoma
refractory peripheral t-cell lymphoma

Summary

To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.

Description

Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. The investigators have been proceeding this trial to evaluate the efficacy and safety of the PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.

Details
Condition Peripheral T-Cell Lymphoma, T-Cell Lymphoma, Newly Diagnosed Peripheral T-cell Lymphoma, Newly Diagnosed Peripheral T-cell Lymphoma
Treatment PD-1 blocking antibody, chidamide, lenalidomide and etoposide, PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine
Clinical Study IdentifierNCT04040491
SponsorMingzhi Zhang
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 14 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: T-Cell Lymphoma or Peripheral T-Cell Lymphoma or Newly Diagnosed Peripheral T-cell Lymphoma?
Do you have any of these conditions: T-Cell Lymphoma or Newly Diagnosed Peripheral T-cell Lymphoma or Peripheral T-Cell Lymphoma?
age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score3;expected survival3 months
patients with Peripheral T-cell Lymphoma diagnosed by immuno-histochemistry (IHC)
acceptable hematological indicators, no chemotherapy contraindications
total bilirubin 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) 2.5 x upper age limit (ULN), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group
At least one measurable lesion by CT or PET-CTPositron Emission Tomography-Computed Tomography
exclude other major diseases, normal heart and lung function
Female patients of childbearing age are negative for pregnancy test
Cooperate with follow-up
There are no other related treatments including traditional Chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms)
Signing informed consent : Pathological histology must be consulted by a pathologist at a provincial hospital

Exclusion Criteria

Patients with ALK-positive Anaplastic Large Cell Lymphoma or angioimmunoblastic T-cell lymphoma
rejecting providing blood preparation
allergic to drug in this study and with metabolic block
rejecting adopting reliable contraceptive method in pregnancy or lactation period
uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac, lung, liver and pancreas
with severe infection
with primary or secondary central nervous system tumor invasion
with immunotherapy or radiotherapy contraindication
ever suffered with malignant tumor
having peripheral nervous system disorder or dysphrenia
with no legal capacity,medical or ethical reasons affecting research proceeding
participating other clinical trials simultaneously
adopting other anti-tumor medicine excluding this research
Patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients
Human immunodeficiency virus (HIV)-positive patients
the researchers considering it inappropriate to participate in the study
Patients with immune system diseases
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