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

NCT04040491 | Unknown Phase 4

• 1 other identifier: hnslblzlzx20190702
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T-cell Lymphoma

Keywords

PD-1; chidamide; lenalidomide; gemcitabine; Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (3)

• Overall Response Rate

  The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.

  From date of randomization until the date tumor volume has reduced, assessed up to 36 months

• Progression-free Survival

  The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

• Overall Survival

  Time from randomization to death for any reason

  From date of randomization until date of death from any cause, assessed up to 36 months

Study Arms (2)

Newly diagnosed PTCL

EXPERIMENTAL

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.

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

Relapse/refractory PTCL

OTHER

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.

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

Interventions

PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine 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.

Newly diagnosed PTCL; Relapse/refractory PTCL

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mingzhi Zhang: lead

Study Sites (1)

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Lenalidomide; Gemcitabine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Central Study Contacts

Mingzhi D Zhang

CONTACT

+8613838565629; Mingzhi_zhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: the director of oncology department of the first affiliated hospital

Model Details: 50 patients for newly diagnosed group and 50 patients for relapse/refractory group.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 31, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: September 1, 2021
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)