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Trial Title:
Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome
NCT ID:
NCT05674539
Condition:
Acute Myeloid Leukemia, Adult
Myelodysplastic Syndrome(MDS)
Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Vidarabine
Fludarabine
Fludarabine phosphate
Melphalan
Busulfan
Conditions: Keywords:
hematopoietic stem cell transplantation (HSCT)
reduced intensity conditioning (RIC)
Acute Myeloid Leukemia(AML)
Myelodysplastic Syndrome(MDS)
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants will be randomized to one of two reduced intensity conditioning (RIC)
regimens (fludarabine plus busulfan and fludarabine plus melphalan)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fludarabine and Busulfan
Description:
Fludarabine with total dose of 150 mg/m^2 in combination with Busulfan with total dose of
6.4 mg/kg
Arm group label:
fludarabine and busulfan
Other name:
Fludara and Busulfex
Intervention type:
Drug
Intervention name:
Fludarabine and Melphalan
Description:
Fludarabine with total dose of 150 mg/m^2 in combination with Melphalan with total dose
of 140 mg/m^2
Arm group label:
fludarabine and melphalan
Other name:
Busulfex and Fludara
Summary:
The goal of this clinical trial is to compare outcomes of two reduced intensity
conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in
allogeneic hematopoietic stem cell transplantation (HSCT) for acute myeloid leukemia
(AML) or myelodysplastic syndrome (MDS) patients. The main questions it aims to answer
are:
- The safety of two reduced intensity conditioning (RIC) regimens (fludarabine plus
busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell
transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years.
- The efficacy of two reduced intensity conditioning (RIC) regimens (fludarabine plus
busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell
transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years.
Participants will be randomized to one of two reduced intensity conditioning (RIC)
regimens (fludarabine plus busulfan and fludarabine plus melphalan)
Detailed description:
Patients are randomized to one of two reduced intensity conditioning (RIC) regimens: the
combination of fludarabine (30 mg/m^2/day, days -6 to days -2, the total dase is 150
mg/m^2) and busulfan (3.2 mg/kg/day, days -3 to days -2, the total dose is 6.4 mg/kg)
(Flu/Bu) or fludarabine (30 mg/m^2/day, days -6 to days -2, the total dose is 150 mg/m^2)
and melphalan (70 mg/m^2/day, days -3 to days -2, the total dose is 140 mg/m^2)
(Flu/Mel). A total of 200 patients (100 to each arm) will be recruited in this study over
a period of two years. Patients will be followed for up to 18 months from allogeneic
hematopoietic stem cell transplantation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age equal or more than 18 years old.
- Patients diagnosed with AML or MDS.
- Patients who have related or unrelated bone marrow or peripheral blood donors and
plan to undergo hematopoietic stem cell transplantation.
- Hct-specific complication index score (HCT-CI) more than or equal to 3 or the age of
Patients ≥55 years.
- Sign the informed consent, promise to abide by the research procedures, and
cooperate with the implementation of the whole process of the research.
Exclusion Criteria:
- Patients with central nervous system involvement.
- Patients with HIV seropositive.
- Patients with other serious diseases and a life expectancy of less than six months
- Patients with severe mental or psychological disorders.
- Patients without written informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wuhan Union Hospital, Tongji Medical college, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Linghui Xia, Professor
Phone:
00-86-18627733999
Email:
linghuixia@hust.edu.cn
Contact backup:
Last name:
Wei Shi, Professor
Phone:
00-86-13207131315
Email:
496020121@qq.com
Investigator:
Last name:
Linghui Xia, Professor
Email:
Principal Investigator
Investigator:
Last name:
Wei Shi, Professor
Email:
Principal Investigator
Investigator:
Last name:
Miaomiao Zhao, Doctor
Email:
Sub-Investigator
Start date:
December 28, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05674539
