Clinical trial NCT04490590: A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma
Official title: A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: NK/T-Cell Lymphoma
Keywords: Chidamide combined with Etoposide
ORR
CR
PR
TTR
DOR
PFS
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 24 months
Secondary outcomes:
measure: Time To Response (TTR)
timeFrame: Up to 3 months
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Progression Free Survival (PFS) Progression Free Survival
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Lei Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: