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

NCT03611231 | Unknown Phase 2

• 1 other identifier: CSIIT-Q06
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Experimental Tumor

Outcome Measures

Primary Outcomes (1)

• progression-free survival（PFS）

  Time from treatment until disease progression or death

  up to 2 years

Secondary Outcomes (2)

• overall survival（OS）

  up to 2 years

• Treatment-related adverse events (AEs)

  2 years

Study Arms (1)

Experimental

EXPERIMENTAL

chidamide

Drug: Chidamide

Interventions

Chidamide DRUG

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

Also known as: epidaza

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age 18-70 years, male or female;
• ECOG performance status 0-1;
• 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;
• Blood routine test: absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
• Life expectancy no less than 3 months;
• Patients willing to sign the Informed Consent Form.

You may not qualify if:

• Patients relapsed after ASCT
• Patients with HBsAg positive or HBcAb positive patients also detected HBV-DNA copy number positive;
• Patients with active HCV infection;
• Patients with active HIV infection;
• Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue disease, severe infectious diseases and others;
• Patients with liver cirrhosis or evidence of liver fibrosis;
• Patients with a QTc longer than 500 ms;
• Patients with mental disorders or those do not have the ability to consent;
• Patients with drug abuse, long term alcoholism that may impact the results of the trial;
• Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures;
• Non-appropriate patients for the trial according to the judgment of the investigators;

Sponsors & Collaborators

• Peking University: lead
• Hebei Medical University Fourth Hospital: collaborator
• Peking University International Hospital: collaborator

Study Sites (1)

Beijing

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Neoplasms, Experimental

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Neoplasms

Central Study Contacts

Yuqin Song, Dr.

CONTACT

0086 13683398726‬‬‬; songyuqin622@163.com

Jun Zhu, Dr.

CONTACT

010-88140650; dreaming2217@hotmai.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: August 2, 2018
• Study Start: September 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2022
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)