Back to resultsPD-1 Antibody, Chidamide, Lenalidomide and Etoposide for 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
PD-1 Antibody, chidamide, lenalidomide and etoposide
Sponsored by
About this trial
This is an interventional treatment trial for NK/T Cell Lymphoma focused on measuring PD-1 Antibody, chidamide, lenalidomide, etoposide, NK/T-cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months;
- patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH);
- Refractory or relapse after at least 2 regimen;
- Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence;
- 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;
- At least one measurable lesion;
- There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal;
- Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication;
- 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
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 Chemotherapy 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;
- Patients with immune system diseases;
- Those who have no legal capacity or whose research is affected by medical or ethical reasons;
Sites / Locations
- Oncology Department of The First Affilliated Hospital of Zhengzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PD-1 Antibody, chidamide, lenalidomide and etoposide
Arm Description
PD-1 Antibody: 240mg, d1, Chidamide: 20mg, twice a week, Lenalidomide: 25mg, d1-14 Etoposide:100mg/m2, d1-3 and 21 days made one treatment cycle.
Outcomes
Primary Outcome Measures
Overall Response Rate
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.
Secondary Outcome Measures
Progression-free Survival
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Overall Survival
Time from randomization to death for any reason.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04038411
Brief Title
PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma
Official Title
Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory Natural Killer/T Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To observe the safety, tolerability and clinical effects of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma.
Detailed Description
This is a prospective, open-label, one-arm, multicenter clinical trial, aimed to evaluate the safety, tolerability, and efficacy of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma. A total of 50 patients are planned to be enrolled into the study. The primary end points are objective responder rate (ORR) and progression free survival(PFS) and the secondary end points include overall survival(OS) , 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
PD-1 Antibody, chidamide, lenalidomide, etoposide, NK/T-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD-1 Antibody, chidamide, lenalidomide and etoposide
Arm Type
Experimental
Arm Description
PD-1 Antibody: 240mg, d1, Chidamide: 20mg, twice a week, Lenalidomide: 25mg, d1-14 Etoposide:100mg/m2, d1-3 and 21 days made one treatment cycle.
Intervention Type
Drug
Intervention Name(s)
PD-1 Antibody, chidamide, lenalidomide and etoposide
Intervention Description
PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA.
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.
Time Frame
From date of randomization until the date of first date tumor volume has reduced, assessed up to 36 months
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Title
Overall Survival
Description
Time from randomization to death for any reason.
Time Frame
From date of randomization until date of death from any cause, assessed up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months;
patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH);
Refractory or relapse after at least 2 regimen;
Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence;
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;
At least one measurable lesion;
There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal;
Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication;
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
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 Chemotherapy 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;
Patients with immune system diseases;
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
Mingzhi D Zhang
Phone
+8613838565629
Ext
+8613838565629
Email
Mingzhi_zhang@126.com
Facility Information:
Facility Name
Oncology Department of The First Affilliated 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
+8613838565629
Email
Mingzhi_zhang@126.com
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang, Zhang
Phone
+8613838565629
Email
Mingzhi_zhang@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T Cell Lymphoma
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