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

NCT ID: NCT04490590

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2021-10-01

Brief Summary

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

Detailed 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.

Conditions

NK/T-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide+ Etoposide capsule

Chidamide: 30mg, twice a week(BIW), PO.

Etoposide capsule:50mg, quaque die （QD）, PO, d1-10，21days for one cycle. Patients receive the other treatment of chidamide and etoposide capsule, and those who have achieved PD(progressive disease) will give the other treatment.

Group Type: EXPERIMENTAL

Chidamide+ Etoposide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mingzhi Zhang

OTHER

Sponsor Role: lead

Responsible Party

Mingzhi Zhang

The director of oncology department of the first affiliated hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lei Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Zhang, Professor

Role: CONTACT

zl2909@163.com

13525533696

Mingzhi Zhang, Professor

Role: CONTACT

mingzhi_zhang@126.com

138385656

Facility Contacts

Mingzhi Zhang, Pro,Dr

Role: primary

mingzhi_zhang@126.com

13838565629

Other Identifiers

hnslblzlzx20180814

Identifier Type: -

Identifier Source: org_study_id