Radiotherapy Combined With GDP With or Without Chidamide in Stage I/II Extranodal Nasal NK/T-cell Lymphoma

Lymphoma Clinical Trial

Official title:

Radiotherapy Combined With GDP (Gemcitabine, Cisplatin, Dexamethasone) Chemotherapy With or Without Chidamide in High-risk Early-stage Extranodal Nasal NK/T-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04511351
• Other study ID #: CAMS lymphoma
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2020
• Source: Chinese Academy of Medical Sciences
• Contact: Mei Dong
• Phone: 010-87787447
• Email: dongmei030224[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell

Intervention

Drug:
• Chidamide
chidamide administration during radiation and chemotherapy phase in the study group

Locations

Country	Name	City	State
China	National Cancer Center, Cancer Hospital, Chinese Academy of Medical Scienses	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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	Overall Survival	Defined as the time from the date of study treatment until death from any cause	2 years
Secondary	Treatment response	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