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

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mingzhi Zhang
• Treatments: Antibodies; Antibodies, Blocking; Etoposide; Etoposide phosphate; Gemcitabine; Immunoglobulins; Lenalidomide

Criteria

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