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

Mingzhi Zhang

Status and phase

Unknown

Phase 4

Conditions

Peripheral T-cell Lymphoma

Treatments

Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT04040491

hnslblzlzx20190702

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

14 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤3;expected survival≥3 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-CT（Positron 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