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

NCT ID: NCT03611231

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-12-30

Brief 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

Detailed 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

Conditions

Experimental Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

chidamide

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

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

Interventions

Chidamide

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

Intervention Type: DRUG

Other Intervention Names

epidaza

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: collaborator

Peking University International Hospital

OTHER

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yuqin Song, Dr.

Role: CONTACT

songyuqin622@163.com

0086 13683398726‬‬‬

Jun Zhu, Dr.

Role: CONTACT

dreaming2217@hotmai.com

010-88140650

Facility Contacts

Yuqin Song, Dr.

Role: primary

songyuqin622@163.com

0086 ‭13683398726

Other Identifiers

CSIIT-Q06

Identifier Type: -

Identifier Source: org_study_id