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

July 29, 2019 updated by: Mingzhi Zhang

Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory Natural Killer/T Cell Lymphoma

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

Study Overview

Status

Unknown

Conditions

Detailed Description

This is a prospective, open-label, one-arm, multicenter clinical trial, aimed to evaluate the safety, tolerability, and efficacy of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma. A total of 50 patients are planned to be enrolled into the study. The primary end points are objective responder rate (ORR) and progression free survival(PFS) and the secondary end points include overall survival(OS) , and adverse events.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • Oncology Department of The First Affilliated Hospital of Zhengzhou University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months;
  2. patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH);
  3. Refractory or relapse after at least 2 regimen;
  4. Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence;
  5. 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;
  6. At least one measurable lesion;
  7. There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal;
  8. Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication;
  9. There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied;
  10. Can understand the situation of this study and sign the informed consent voluntarily

Exclusion Criteria:

  1. rejecting providing blood preparation;
  2. allergic to drug in this study or with hemophagocytic syndrome;
  3. rejecting adopting reliable contraceptive method in pregnancy or lactation period;
  4. uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas);
  5. with severe infection;
  6. with primary or secondary central nervous system tumor invasion;
  7. with Chemotherapy or radiotherapy contraindication;
  8. ever suffered with malignant tumor;
  9. Human immunodeficiency virus (HIV)-positive patients
  10. Drug abuse or long-term alcohol abuse that affects the evaluation of test results;
  11. Have peripheral nervous system disorder or mental disorder;
  12. Patients with immune system diseases;
  13. Those who have no legal capacity or whose research is affected by medical or ethical reasons;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-1 Antibody, chidamide, lenalidomide and etoposide
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: From date of randomization until the date of first date tumor volume has reduced, assessed up to 36 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: 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
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 Frame: From date of randomization until date of death from any cause, assessed up to 36 months
Time from randomization to death for any reason.
From date of randomization until date of death from any cause, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

April 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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