PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma

NCT04038411 | Unknown Phase 4

• 1 other identifier: hnslblzlzx2019070202
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To observe the safety, tolerability and clinical effects of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma.

Conditions

NK/T Cell Lymphoma

Keywords

PD-1 Antibody; chidamide; lenalidomide; etoposide; NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 of first date tumor volume has reduced, assessed up to 36 months

Secondary Outcomes (2)

• Progression-free Survival

  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

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

Study Arms (1)

PD-1 Antibody, chidamide, lenalidomide and etoposide

EXPERIMENTAL

PD-1 Antibody: 240mg, d1, Chidamide: 20mg, twice a week, Lenalidomide: 25mg, d1-14 Etoposide:100mg/m2, d1-3 and 21 days made one treatment cycle.

Drug: PD-1 Antibody, chidamide, lenalidomide and etoposide

Interventions

PD-1 Antibody, chidamide, lenalidomide and etoposide DRUG

PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA.

PD-1 Antibody, chidamide, lenalidomide and etoposide

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≤2;expected survival≥3 months;
• patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH);
• Refractory or relapse after at least 2 regimen;
• Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence;
• No chemotherapy contraindications: hemoglobin ≥ 100g / L, absolute neutrophil count ≥ 1.5 × 109 / L, platelets ≥ 80 × 109 / L, ALT, AST ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal Upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / L;
• At least one measurable lesion;
• There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal;
• Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication;
• There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied;
• Can understand the situation of this study and sign the informed consent voluntarily

You may not qualify if:

• rejecting providing blood preparation;
• allergic to drug in this study or with hemophagocytic syndrome;
• 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 Chemotherapy or radiotherapy contraindication;
• ever suffered with malignant tumor;
• Human immunodeficiency virus (HIV)-positive patients
• Drug abuse or long-term alcohol abuse that affects the evaluation of test results;
• Have peripheral nervous system disorder or mental disorder;
• Patients with immune system diseases;
• Those who have no legal capacity or whose research is affected by medical or ethical reasons;

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, Extranodal NK-T-Cell

Interventions

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

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

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; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Mingzhi D Zhang

CONTACT

+8613838565629; Mingzhi_zhang@126.com

Study Design

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

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 30, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2022
• Last Updated: July 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)