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Status unknownNCT04511351Updated Aug 13, 2020

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

An interventional study of Chidamide in Lymphoma, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by Chinese Academy of Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 years after the study started (first participant enrolled Aug 2014, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lymphoma
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 76 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    RT+GDP+Chidamide

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

    Drug: Chidamide

  • No intervention
    RT+GDP

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

Interventions

  • DrugChidamide

    chidamide administration during radiation and chemotherapy phase in the study group

06

What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

  1. Overall Survival

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

    Time frame: 2 years

  2. 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)

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • National Cancer Center, Cancer Hospital, Chinese Academy of Medical Scienses
    Beijing, Beijing 100021, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04511351
Lead sponsor
Chinese Academy of Medical Sciences
Responsible party
Mei Dong (Director Physician, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Aug 13, 2020
Start date
Aug 1, 2014
Primary completion
Dec 30, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Aug 13, 2020

Study contacts

Mei Dong
Contact
dongmei030224@163.com
010-87787447
Mei Dong
principal investigator · Cancer Hospital, Chinese Academy of Medical Scienses

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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