- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04511351
Radiotherapy Combined With GDP With or Without Chidamide in Stage I/II Extranodal Nasal NK/T-cell Lymphoma
August 12, 2020 updated by: Mei Dong, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Radiotherapy Combined With GDP (Gemcitabine, Cisplatin, Dexamethasone) Chemotherapy With or Without Chidamide in High-risk Early-stage Extranodal Nasal NK/T-cell Lymphoma
Currently, combined chemotherapy (CT) and radiation (RT) is recognized as the standard treatment for high-risk early-stage NKTCL.
However, treatment failure occured in nearly 30% of patients receiving CRT and systemic failure are the most common failure form.
Chidamide is a HADC inhibitor, which presents satisfactory efficacy in NKTCL especially in terms of improving durable remission time.
In our previous study, IMRT followed by GDP was demonstrated effective in early-stage NKTCL.
Therefore, we designed a prospective phase II clinical trial of IMRT followed by GDP with or without chidamide in patients with high-risk early-stage NKTCL.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mei Dong
- Phone Number: 010-87787447
- Email: dongmei030224@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- National Cancer Center, Cancer Hospital, Chinese Academy of Medical Scienses
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
- no prior radiotherapy or chemotherapy;
- age ≥ 18 years;
- ECOG performance status 0-2;
- Ann Arbor stages I and II;
- tumors primarily occurring in the upper aerodigestive tract;
- at least one unfavorable prognostic factor (age > 60 years, B symptoms, elevated LDH, ECOG score 2, regional node involvement, and PTI);
- 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 advanced stage disease;
- pregnancy or lactation;
- any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RT+GDP+Chidamide
IMRT followed by GDP chemotherapy with chidamide during radiation and chemotherapy phase
|
chidamide administration during radiation and chemotherapy phase in the study group
|
No Intervention: RT+GDP
IMRT followed by GDP chemotherapy without chidamide during radiation and chemotherapy phase
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 2 years
|
Defined as the time from the date of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 2 years
|
Defined as the time from the date of study treatment until death from any cause
|
2 years
|
Treatment response
Time Frame: 2 years
|
Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014)
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mei Dong, Cancer Hospital, Chinese Academy of Medical Scienses
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2014
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
August 10, 2020
First Submitted That Met QC Criteria
August 12, 2020
First Posted (Actual)
August 13, 2020
Study Record Updates
Last Update Posted (Actual)
August 13, 2020
Last Update Submitted That Met QC Criteria
August 12, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMS lymphoma
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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