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

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03630731
• Other study ID #: MCCRENT
• Status: Recruiting
• Phase: Phase 2
• Start date: August 2018
• Est. completion date: March 2020

Study information

• Verified date: August 2018
• Source: Chinese Academy of Medical Sciences
• Contact: Mei Dong
• Phone: 13811929322
• Email: dongmei030224[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell
• Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Intervention

Drug:
• chidamide
For those who responded to induction chemotherapy, chidamide will be given OR orally 30mg biw for at least half a year

Locations

Country	Name	City	State
China	Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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