Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGChidamide
chidamide administration during radiation and chemotherapy phase in the study group
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas; 2. no prior radiotherapy or chemotherapy; 3. age ≥ 18 years; 4. ECOG performance status 0-2; 5. Ann Arbor stages I and II; 6. tumors primarily occurring in the upper aerodigestive tract; 7. at least one unfavorable prognostic factor (age \> 60 years, B symptoms, elevated LDH, ECOG score 2, regional node involvement, and PTI); 8. at least one measurable lesion; 9. 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; 10. life expectancy of more than 3 months.
Exclusion criteria
1. Patients with advanced stage disease; 2. pregnancy or lactation; 3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment response | 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) |
| Overall Survival | 2 years | Defined as the time from the date of study treatment until death from any cause |
Countries
China
Contacts
Primary ContactMei Dong
Outcome results
None listed