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

NCT ID: NCT04511351

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-01
• Study Completion Date: 2020-12-30

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.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT+GDP+Chidamide

IMRT followed by GDP chemotherapy with chidamide during radiation and chemotherapy phase

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

chidamide administration during radiation and chemotherapy phase in the study group

RT+GDP

IMRT followed by GDP chemotherapy without chidamide during radiation and chemotherapy phase

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Chidamide

chidamide administration during radiation and chemotherapy phase in the study group

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mei Dong

Director Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei Dong

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital, Chinese Academy of Medical Scienses

Locations

National Cancer Center, Cancer Hospital, Chinese Academy of Medical Scienses

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mei Dong

Role: CONTACT

dongmei030224@163.com

010-87787447

Facility Contacts

Mei Dong

Role: primary

dongmei030224@163.com

13811929322

Other Identifiers

CAMS lymphoma

Identifier Type: -

Identifier Source: org_study_id