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

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

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

Study Overview

• Status: Unknown
• Conditions: Experimental Tumor
• Intervention / Treatment: Drug: Chidamide

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

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jun Zhu, Dr.; Phone Number: 010-88140650; Email: dreaming2217@hotmai.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • BEIJING

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; chidamide	Drug: Chidamide; Chidamide 20mg orally BIW. Treatment cycles are repeated every 4 weeks.; Other Names: epidaza

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival（PFS）	Time from treatment until disease progression or death	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival（OS）	Time from treatment until death from any cause	up to 2 years
Treatment-related adverse events (AEs)	Physiological parameter	2 years

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Peking University International Hospital; Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms, Experimental
• Other Study ID Numbers: CSIIT-Q06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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