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

NK/T Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04038411
• Other study ID #: hnslblzlzx2019070202
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2019
• Source: Zhengzhou University
• Contact: Mingzhi D Zhang
• Phone: +8613838565629
• Email: Mingzhi_zhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• NK/T Cell Lymphoma

Intervention

Drug:
• PD-1 Antibody, chidamide, lenalidomide and etoposide
PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-a. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA.

Locations

Country	Name	City	State
China	Oncology Department of The First Affilliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Mingzhi Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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