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Trial Title:
Fractionated Busulfan Conditioning Regimen for Allo-HSCT in Non-remission Myeloid Malignancies
NCT ID:
NCT05807659
Condition:
Myeloid Malignancies
Conditions: Official terms:
Neoplasms
Busulfan
Conditions: Keywords:
myeloid malignancies
allo-HSCT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
fractionated busulfan-based conditioning regimen
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
Arm group label:
fractionated busulfan
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chendu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Ji, MD
Phone:
86-28-85422370
Email:
jijie@wchscu.cn
Start date:
March 16, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05807659
