Radiotherapy Combined With GDP (Gemcitabine, Cisplatin, Dexamethasone) Chemotherapy With or Without Chidamide in High-risk Early-stage Extranodal Nasal NK/T-cell Lymphoma
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Progression-free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
RT+GDP+Chidamide
IMRT followed by GDP chemotherapy with chidamide during radiation and chemotherapy phase
Intervention: Chidamide (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall Survival(2 years)
- Treatment response(2 years)
Investigators
Mei Dong
Director Physician
Chinese Academy of Medical Sciences