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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
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

First Posted
August 10, 2020
Last Updated
August 12, 2020
Sponsor
Chinese Academy of Medical Sciences
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
No
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
Email
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
Email
dongmei030224@163.com

12. IPD Sharing Statement

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

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