A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma
- Registration Number
- NCT04490590
- Lead Sponsor
- Mingzhi Zhang
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chidamide+ Etoposide capsule Chidamide+ Etoposide 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) up to 24 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Oncology Department of The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China