Chidamide Plus PTCy/Cyclosporine to Prevent GVHD After Myeloablative Conditioning, Matched PBSCT

NCT03336632 | Unknown Phase 2

• 1 other identifier: HX-GVHD-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to explore the efficacy and safety of introduction of chidamide in PTCy based GVHD prophylaxis in patients undergoing allogeneic PBSCT.

Conditions

Leukemia, Acute; MDS

Keywords

PBSCT; myeloablative conditioning; HDACi; chidamide

Outcome Measures

Primary Outcomes (1)

• aGVHD

  accumulated incidence of aGVHD

  100 day after infusion of PBSCs

Secondary Outcomes (4)

• GRFS

  3 years after recruitment

• DFS

  3 years after recruitment

• OS

  3 years after recruitment

• cGVHD

  2 yeas after infusion of PBSCs

Study Arms (1)

Chidamide

EXPERIMENTAL

Chidamide, tablets, 5 mg/tablet, 20 mg orally twice weekly from D-7\~+14 Cyclophosphamide: 50 mg/Kg intravenously D+3, +4 Cyclosporine A: intravenously then orally 3 mg/Kg D+5\~D+100

Drug: Chidamide; Drug: Cyclophosphamide; Drug: cyclosporine A

Interventions

Chidamide DRUG

20 mg orally, twice weekly from D-7 to D+14

Also known as: HBI-8000

Chidamide

Cyclophosphamide DRUG

50 mg/Kg intravenously D+3, +4

Chidamide

cyclosporine A DRUG

3 mg/Kg intravenously then orally from D+5 to D+100 if no acute graft-versus-host disease

Also known as: cyclosporine

Chidamide

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 16 years or older, and ≤ 65 years at time of enrollment
• Signed informed consent
• Hematologic disorder requiring allogeneic hematopoietic cell transplantation
• Left ventricular ejection fraction (LVEF) ≥ 45% by multiple uptake gated acquisition (MUGA) scan or echocardiogram
• Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and diffusing lung capacity oxygenation (DLCO) adjusted ≥ 50% of predicted values on pulmonary function tests
• Transaminases (AST, ALT) \< 3 times upper limit of normal (ULN) values
• Creatinine clearance calculated ≥ 50 mL/min
• Karnofsky Performance Status Score ≥ 60%.
• Human leukocyte antigen (HLA) matched 8/ (A, B, C, DRB1) related or unrelated donor

You may not qualify if:

• Active infection not controlled with appropriate antimicrobial therapy HIV, hepatitis B (HBcAb positive but HBsAg negative with undetectable viral load are eligible), or hepatitis C infection
• Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) ≥4
• Anti-thymocyte globulin (ATG) as part of the conditioning regimen
• Pregnancy
• Histone deacetylase (HDAC), DAC, HSP90 inhibitors or valproic acid for the treatment of cancer within 30 days
• Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first chidamide treatment
• Impaired cardiac function or clinically significant cardiac diseases, including any one of the following: Any history of ventricular fibrillation or torsade de pointes; Bradycardia defined as heart rate (HR)\< 45 bpm (Patients with pacemakers are eligible if HR ≥ 45 bpm); Screening electrocardiogram (ECG) with a QTcF \> 480 msec; Right bundle branch block + left anterior hemiblock (bifascicular block); Patients with myocardial infarction or unstable angina ≤ 12 months prior to starting study drug; Other clinically significant heart disease (e.g., New York Heart Association (NYHA) class III or IV , uncontrolled hypertension) as per discretion of principal investigator and/or treating physician; Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug with the exception of drugs listed on Appendix B of study documents that are required for hematopoietic cell transplantation (HCT) patients.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (2)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

MeSH Terms

Conditions

Leukemia

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; HBI-8000; Cyclophosphamide; Cyclosporine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ting Liu, MD

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Jie Ji, MD

CONTACT

86-28-85422373; jieji@scu.edu.cn

Ting Liu, MD PHD

CONTACT

86-28-85422370; liuting@scu.edu.cn

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: MD

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: January 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: March 30, 2021
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)