A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma

NK/T-Cell Lymphoma Clinical Trial

Official title:

A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490590
• Other study ID #: hnslblzlzx20180814
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2016
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2020
• Source: Zhengzhou University
• Contact: Lei Zhang, Professor
• Phone: 13525533696
• Email: zl2909[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To observe the safety, tolerability and clinical effects of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma.

Description:

This is a prospective, open-label, one-arm, single center clinical trial, aimed to evaluate the safety, tolerability, and efficacy of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma. A total of 30 patients are planned to be enrolled into the study. Patients with diagnosis of Relapsed or Refractory NK/T-cell Lymphoma will be treated with Chidamide plus Etoposide capsules. The primary end points are objective responder rate (ORR) and a time to response(TTR) and response duration (DOR) and progression free survival(PFS) and adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 65 Years

Eligibility

Inclusion Criteria:

1.age:10-65 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 Chemotherap 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. 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:
• Chidamide+ Etoposide
Patients will receive the treatment of and chidamide and etoposide capsule, and those who have achieved CR(complete response)or PR(partial response)or SD(stable disease)will continue the treatment.

Locations

Country	Name	City	State
China	Oncology Department of The First Affiliated 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	Objective Response Rate (ORR)		up to 24 months
Secondary	Time To Response (TTR)		Up to 3 months
Secondary	Duration of Response (DOR)		Up to 2 years
Secondary	Progression Free Survival (PFS) Progression Free Survival		up to 24 months