Maintenance Treatment of Chidamide in Stage IV or Relapsed/Refractory Extranodal NK/T-cell Lymphoma

Maintenance Treatment of Chidamide in Chemotherapy-responded Stage IV or Relapsed/Refractory Extranodal Natural Killer/T-cell Lymphoma, Nasal Type

Extranodal natural killer/T-cell lymphoma, nasal type (NKTCL) is a highly aggressive peripheral T-cell lymphoma (PTCL). Patients with newly diagnosed stage IV and relapsed/refractory have poor prognosis. 5-year progression-free survival was reported only 55%. Chidamide is a selective histone deacetylase inhibitor which was approved by FDA in treating relapsed or refractory PTCL. In phase I and II studies of chidamide, patients with relapsed or refractory NKTCL achieved a higher overall remission. Patients who obtained complete or partial remission had much favourable duration of remission. Thus, the invesgator design this study to evaluate the role of maintenance treatment of chidamide for induction chemotherapy-responded newly-diagnosed advanced and relapsed/refractory NKTCL patients.

Study Overview

• Status: Unknown
• Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
• Intervention / Treatment: Drug: chidamide

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;
2. newly-diagnosed stage IV disease or relapsed or refractory disease；
3. age ≥ 18 years;
4. ECOG performance status 0-2;
5. at least one measurable lesion;
6. 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;
7. life expectancy of more than 3 months.

Exclusion Criteria:

1. Patients with newly-diagnosed stage I-II disease;
2. pregnancy or lactation;
3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	PFS was defined as the period from the date of treatment till the date of disease progression, relapse, or death from any cause.	1 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Mei Dong, Cancer Hospital, Chinese Academy of Medical Science

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2018
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (ACTUAL): August 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: MCCRENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No