Back to resultsA Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma
Primary Purpose
NK/T-Cell Lymphoma
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Chidamide+ Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for NK/T-Cell Lymphoma focused on measuring Chidamide combined with Etoposide, ORR, CR, PR, TTR, DOR, PFS
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:
- 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;
Sites / Locations
- Oncology Department of The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chidamide+ Etoposide capsule
Arm Description
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.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
Secondary Outcome Measures
Time To Response (TTR)
Duration of Response (DOR)
Progression Free Survival (PFS) Progression Free Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04490590
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mingzhi Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NK/T-Cell Lymphoma
Keywords
Chidamide combined with Etoposide, ORR, CR, PR, TTR, DOR, PFS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chidamide+ Etoposide capsule
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chidamide+ Etoposide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Time To Response (TTR)
Time Frame
Up to 3 months
Title
Duration of Response (DOR)
Time Frame
Up to 2 years
Title
Progression Free Survival (PFS) Progression Free Survival
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Zhang, Professor
Phone
13525533696
Email
zl2909@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mingzhi Zhang, Professor
Phone
138385656
Email
mingzhi_zhang@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, Professor
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Department of The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang, Pro,Dr
Phone
13838565629
Email
mingzhi_zhang@126.com
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma
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