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

NCT ID: NCT04040491

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-09-01

Brief 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.

Detailed 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.

Conditions

Peripheral T-cell Lymphoma

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Newly diagnosed PTCL

PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.

Group Type: EXPERIMENTAL

PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine

Intervention Type: DRUG

PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Gemcitabine is a cytosine nucleoside derivative, its main metabolite incorporates into DNA in cells and mainly acts on G1 / S phase.

Relapse/refractory PTCL

PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle.

Group Type: OTHER

PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine

Intervention Type: DRUG

PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Gemcitabine is a cytosine nucleoside derivative, its main metabolite incorporates into DNA in cells and mainly acts on G1 / S phase.

Interventions

PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine

PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Gemcitabine is a cytosine nucleoside derivative, its main metabolite incorporates into DNA in cells and mainly acts on G1 / S phase.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mingzhi Zhang

OTHER

Sponsor Role: lead

Responsible Party

Mingzhi Zhang

the director of oncology department of the first affiliated hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingzhi D Zhang

Role: CONTACT

Mingzhi_zhang@126.com

+8613838565629 ext. +8613838565629

Facility Contacts

Mingzhi Zhang, Pro,Dr

Role: primary

Mingzhi_zhang@126.com

+8613838565629

Mingzhi Zhang, Zhang

Role: backup

Mingzhi_zhang@126.com

+8613838565629

Other Identifiers

hnslblzlzx20190702

Identifier Type: -

Identifier Source: org_study_id