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

Primary Purpose

Lymphoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Chidamide

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RT+GDP+Chidamide

RT+GDP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival

Defined as the time from the date of study treatment until death from any cause

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)

Full Information

NCT ID

NCT04511351

First Posted

August 10, 2020

Last Updated

August 12, 2020

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04511351

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2014 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RT+GDP+Chidamide

Arm Type

Experimental

Arm Description

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

Arm Title

RT+GDP

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Chidamide

Intervention Description

chidamide administration during radiation and chemotherapy phase in the study group

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Defined as the time from the date of study treatment until death from any cause

Time Frame

2 years

Title

Treatment response

Description

Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mei Dong

Phone

010-87787447

dongmei030224@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mei Dong

Organizational Affiliation

Cancer Hospital, Chinese Academy of Medical Scienses

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mei Dong

Phone

13811929322

dongmei030224@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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