Chidamide Maintenance After Autologous Hematopoietic Stem Cell Transplantation for Relapsed, Refractory or High-risk Lymphoma

Experimental Tumor Clinical Trial

Official title:

Chidamide Maintenance Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Relapsed, Refractory or High-risk Lymphoma : a Prospective, Multi-centric, Single Arm, Open Label Phase II Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03611231
• Other study ID #: CSIIT-Q06
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2018
• Source: Peking University
• Contact: Yuqin Song, Dr.
• Phone: 0086 13683398726???
• Email: songyuqin622[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chidamide Maintenance Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Relapsed, Refractory or High-risk Lymphoma : a Prospective, Multi-centric, Single Arm, Open Label Phase II Clinical Trial

Description:

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as Maintenance Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Relapsed, Refractory or High-risk Lymphoma

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 43
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with B-NHL,NK/T-NHL and HL were confirmed by histopathology examination had received autologous hematopoietic stem cell transplantation (including secondary transplantation). Transplantation interval was 6-8 weeks before in the study. The first diagnostic risk classification or pre-transplant disease status of each type of lymphoma is as follows: 1)B-NHL: patients who are at high risk according to the corresponding international prognostic index in the first diagnosis(IPI>3 /aa IPI >2 /FLIPI>3); Patients must have received at least one first-line induction therapy but did not achieve CR or had relapse after CR; 2)NK/T-NHL: Including all patients, unlimited risk classification and pre-transplant disease status; 3)HL: Patients must have received at least one first-line induction therapy

2. Age 18-70 years, male or female;

3. ECOG performance status 0-1;

4. Organ function should fit the following : Renal function with serum creatinine < 160µmol/L; Liver function with Total bilirubin =2 times of normal maximum, ALT and AST=3 times of normal maximum. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) = 50% of expected corrected for hemoglobin. Adequate cardiac function with left ventricular ejection fraction = 50%. No symptomatic cardiac disease;

5. Blood routine test: absolute neutrophil count =1.5×109/L, platelet =75×109/L, Hb = 90g/L;

6. Life expectancy no less than 3 months;

7. Patients willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Patients relapsed after ASCT

2. Patients with HBsAg positive or HBcAb positive patients also detected HBV-DNA copy number positive;

3. Patients with active HCV infection;

4. Patients with active HIV infection;

5. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue disease, severe infectious diseases and others;

6. Patients with liver cirrhosis or evidence of liver fibrosis;

7. Patients with a QTc longer than 500 ms;

8. Patients with mental disorders or those do not have the ability to consent;

9. Patients with drug abuse, long term alcoholism that may impact the results of the trial;

10. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures;

11. Non-appropriate patients for the trial according to the judgment of the investigators;

Related Conditions & MeSH terms

• Experimental Tumor

Intervention

Drug:
• Chidamide
Chidamide 20mg orally BIW. Treatment cycles are repeated every 4 weeks.

Locations

Country	Name	City	State
China	Beijing	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University	Hebei Medical University Fourth Hospital, Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival(PFS)	Time from treatment until disease progression or death	up to 2 years
Secondary	overall survival(OS)	Time from treatment until death from any cause	up to 2 years
Secondary	Treatment-related adverse events (AEs)	Physiological parameter	2 years