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

NCT04490590 | Unknown Phase 4 FDA Drug

• 1 other identifier: hnslblzlzx20180814
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

NK/T-Cell Lymphoma

Keywords

Chidamide combined with Etoposide; ORR; CR; PR; TTR; DOR; PFS

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  up to 24 months

Secondary Outcomes (3)

• Time To Response (TTR)

  Up to 3 months

• Duration of Response (DOR)

  Up to 2 years

• Progression Free Survival (PFS) Progression Free Survival

  up to 24 months

Study Arms (1)

Chidamide+ Etoposide capsule

EXPERIMENTAL

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.

Drug: Chidamide+ Etoposide

Interventions

Chidamide+ Etoposide 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.

Chidamide+ Etoposide capsule

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 Chemotherap 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;
• 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 Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Lei Zhang, Professor

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhang, Professor

CONTACT

13525533696; zl2909@163.com

Mingzhi Zhang, Professor

CONTACT

138385656; 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 25, 2020
• First Posted: July 29, 2020
• Study Start: October 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

CN (1)