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

NCT04511351 | Unknown

• 1 other identifier: CAMS lymphoma
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival

  2 years

• Treatment response

  2 years

Study Arms (2)

RT+GDP+Chidamide

EXPERIMENTAL

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

Drug: Chidamide

RT+GDP

NO INTERVENTION

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

Interventions

Chidamide DRUG

chidamide administration during radiation and chemotherapy phase in the study group

RT+GDP+Chidamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with advanced stage disease;
• pregnancy or lactation;
• any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mei Dong

  Cancer Hospital, Chinese Academy of Medical Scienses

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Dong

CONTACT

010-87787447; dongmei030224@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Physician

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 13, 2020
• Study Start: August 1, 2014
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

CN (1)