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

NCT05807659 | Unknown Phase 2

• 1 other identifier: Fra-Bu 1.0
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloid Malignancies

Keywords

myeloid malignancies; allo-HSCT

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival of this group of patients at the end of 2 year

  2 years

Secondary Outcomes (4)

• Non-relapse mortality (NRM)

  6 months

• Relapse rate

  2 years

• Cumulative incidence of acute graft versus host disease (aGVHD)

  Day +100

• Cumulative incidence of chronic graft versus host disease (cGVHD)

  2 years

Study Arms (1)

fractionated busulfan

EXPERIMENTAL

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

Drug: fractionated busulfan-based conditioning regimen

Interventions

fractionated busulfan-based conditioning regimen DRUG

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

fractionated busulfan

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

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: Clinical Professor

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: March 16, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the publication of results of this trial

Locations

CN (1)