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Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission Myeloid Malignancies

Primary Purpose

Myeloid Malignancies

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fractionated busulfan-based conditioning regimen
Sponsored by
Sichuan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloid Malignancies focused on measuring myeloid malignancies, allo-HSCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF); KPS score > 60 or ECOG score 0-2; The expected survival period > 3 months; Those who did not achieve complete remission after 2 or more chemotherapy regimens. The proportion of blasts on bone marrow smears before transplantation was ≥5%. Those who have no central nervous system involvement or serious functional damage to important organs of the body; Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures; Exclusion Criteria: Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.; Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective; Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study; Combined with other malignant tumors and require treatment; Pregnant or lactating females; Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome; Patients with active chronic hepatitis B or active hepatitis C; History of prolonged QT syndrome; Patients considered by other researchers to be unsuitable for this study

Sites / Locations

  • West China Hospital, Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fractionated busulfan

Arm Description

fractionated busulfan-based ChiFAB conditioning regimen: busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6~-3, fludarabine 35mg/m2 d-6~-2 cytarabine 1g/m2,d-6~-2 chidamide 30mg d-13,-10,-6,-3

Outcomes

Primary Outcome Measures

Overall survival (OS)
Overall survival of this group of patients at the end of 2 year

Secondary Outcome Measures

Non-relapse mortality (NRM)
Non-relapse mortality of this group of patients at the end of 6 months
Relapse rate
Relapse rate of this group of patients at the end of 2 year
Cumulative incidence of acute graft versus host disease (aGVHD)
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Cumulative incidence of chronic graft versus host disease (cGVHD)
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year

Full Information

First Posted
March 29, 2023
Last Updated
March 29, 2023
Sponsor
Sichuan University
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1. Study Identification

Unique Protocol Identification Number
NCT05807659
Brief Title
Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission Myeloid Malignancies
Official Title
Fractionated Busulfan Combined With Chidamide/Fludarabine/Cytarabine (ChiFAB) With Allogeneic Hematopoietic Stem-Cell Transplantation in Non-remission Myeloid Malignancies: a Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this single-arm phase II study is to test in patients with non-remission myeloid malignancies undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer are: The safety and efficacy of fractionated busulfan Combined With Chidamide/Fludarabine/Cytarabine(ChiFAB) conditioning regimen in increasing the overall survival rate in patients with non-remission myeloid malignancies after allo-HSCT. The efficacy of fractionated busulfan conditioning regimen in reducing the recurrence rate in patients with non-remission myeloid malignancies after allo-HSCT. Participants will receive fractionated busulfan-based ChiFAB conditioning regimen (busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6~-3, fludarabine 35mg/m2 d-6~-2, cytarabine 1g/m2,d-6~-2, chidamide 30mg d-13,-10,-6,-3) before allo-HSCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloid Malignancies
Keywords
myeloid malignancies, allo-HSCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fractionated busulfan
Arm Type
Experimental
Arm Description
fractionated busulfan-based ChiFAB conditioning regimen: busulfan 3.2mg/kg d-13, -12, 1.6mg/kg d-6~-3, fludarabine 35mg/m2 d-6~-2 cytarabine 1g/m2,d-6~-2 chidamide 30mg d-13,-10,-6,-3
Intervention Type
Drug
Intervention Name(s)
fractionated busulfan-based conditioning regimen
Intervention Description
Drug: Chidamide 30 mg oral twice weekly for 2 weeks Drug: Fludarabine 35 mg/m2 intravenously daily for 5 days in the 2nd week Drug: Cytarabine 1 g/m2 intravenously for 5 days in the 2nd week Drug: Busulfan 3.2 mg/kg intravenously daily for 2 days in the 1st week, 1.6 mg/kg intravenously daily for 4 days in the 2nd week Procedure/Surgery: allogeneic hematopoietic stem cell transplantation
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival of this group of patients at the end of 2 year
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Non-relapse mortality (NRM)
Description
Non-relapse mortality of this group of patients at the end of 6 months
Time Frame
6 months
Title
Relapse rate
Description
Relapse rate of this group of patients at the end of 2 year
Time Frame
2 years
Title
Cumulative incidence of acute graft versus host disease (aGVHD)
Description
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Time Frame
Day +100
Title
Cumulative incidence of chronic graft versus host disease (cGVHD)
Description
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF); KPS score > 60 or ECOG score 0-2; The expected survival period > 3 months; Those who did not achieve complete remission after 2 or more chemotherapy regimens. The proportion of blasts on bone marrow smears before transplantation was ≥5%. Those who have no central nervous system involvement or serious functional damage to important organs of the body; Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures; Exclusion Criteria: Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.; Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective; Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study; Combined with other malignant tumors and require treatment; Pregnant or lactating females; Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome; Patients with active chronic hepatitis B or active hepatitis C; History of prolonged QT syndrome; Patients considered by other researchers to be unsuitable for this study
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Ji, MD
Phone
86-28-85422370
Email
jijie@wchscu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Release after the publication of results of this trial
IPD Sharing Time Frame
after the publication of results of this trial

Learn more about this trial

Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission Myeloid Malignancies

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