Back to resultsMaintenance Treatment of Chidamide in Stage IV or Relapsed/Refractory Extranodal NK/T-cell Lymphoma
Primary Purpose
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
chidamide
Sponsored by
About this trial
This is an interventional treatment trial for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Eligibility Criteria
Inclusion Criteria:
- diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
- newly-diagnosed stage IV disease or relapsed or refractory disease；
- age ≥ 18 years;
- ECOG performance status 0-2;
- at least one measurable lesion;
- adequate hematological, hepatic, and renal functions; e.g., absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
- life expectancy of more than 3 months.
Exclusion Criteria:
- Patients with newly-diagnosed stage I-II disease;
- pregnancy or lactation;
- any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
Sites / Locations
- Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)Recruiting
Outcomes
Primary Outcome Measures
PFS
PFS was defined as the period from the date of treatment till the date of disease progression, relapse, or death from any cause.
Secondary Outcome Measures
Full Information
NCT ID
NCT03630731
First Posted
August 7, 2018
Last Updated
August 10, 2018
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03630731
Brief Title
Maintenance Treatment of Chidamide in Stage IV or Relapsed/Refractory Extranodal NK/T-cell Lymphoma
Official Title
Maintenance Treatment of Chidamide in Chemotherapy-responded Stage IV or Relapsed/Refractory Extranodal Natural Killer/T-cell Lymphoma, Nasal Type
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Extranodal natural killer/T-cell lymphoma, nasal type (NKTCL) is a highly aggressive peripheral T-cell lymphoma (PTCL). Patients with newly diagnosed stage IV and relapsed/refractory have poor prognosis. 5-year progression-free survival was reported only 55%. Chidamide is a selective histone deacetylase inhibitor which was approved by FDA in treating relapsed or refractory PTCL. In phase I and II studies of chidamide, patients with relapsed or refractory NKTCL achieved a higher overall remission. Patients who obtained complete or partial remission had much favourable duration of remission. Thus, the invesgator design this study to evaluate the role of maintenance treatment of chidamide for induction chemotherapy-responded newly-diagnosed advanced and relapsed/refractory NKTCL patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
chidamide
Intervention Description
For those who responded to induction chemotherapy, chidamide will be given OR orally 30mg biw for at least half a year
Primary Outcome Measure Information:
Title
PFS
Description
PFS was defined as the period from the date of treatment till the date of disease progression, relapse, or death from any cause.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
newly-diagnosed stage IV disease or relapsed or refractory disease；
age ≥ 18 years;
ECOG performance status 0-2;
at least one measurable lesion;
adequate hematological, hepatic, and renal functions; e.g., absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
life expectancy of more than 3 months.
Exclusion Criteria:
Patients with newly-diagnosed stage I-II disease;
pregnancy or lactation;
any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Dong
Phone
13811929322
Email
dongmei030224@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Dong
Organizational Affiliation
Cancer Hospital, Chinese ACademy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Dong
Phone
(86)13811929322
Email
dongmei030224@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Maintenance Treatment of Chidamide in Stage IV or Relapsed/Refractory Extranodal NK/T-cell Lymphoma
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