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

Myeloid Malignancies Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807659
• Other study ID #: Fra-Bu 1.0
• Status: Recruiting
• Phase: Phase 2
• Start date: March 16, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years old and = 65 years old when signing the Informed Consent Form (ICF);

2. KPS score > 60 or ECOG score 0-2;

3. The expected survival period > 3 months;

4. 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%.

5. Those who have no central nervous system involvement or serious functional damage to important organs of the body;

6. 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:

1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;

2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;

3. 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;

4. Combined with other malignant tumors and require treatment;

5. Pregnant or lactating females;

6. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;

7. Patients with active chronic hepatitis B or active hepatitis C;

8. History of prolonged QT syndrome;

9. Patients considered by other researchers to be unsuitable for this study

Related Conditions & MeSH terms

• Myeloid Malignancies
• Neoplasms

Intervention

Drug:
• fractionated busulfan-based conditioning regimen
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

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chendu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	Overall survival of this group of patients at the end of 2 year	2 years
Secondary	Non-relapse mortality (NRM)	Non-relapse mortality of this group of patients at the end of 6 months	6 months
Secondary	Relapse rate	Relapse rate of this group of patients at the end of 2 year	2 years
Secondary	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	Day +100
Secondary	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	2 years