Actively Recruiting
Molecular Genetics Guide the Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation
Led by Ruijin Hospital · Updated on 2025-05-18
126
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, multicenter, open-label umbrella clinical study planned to enroll 126 subjects with acute myeloid leukemia/myelodysplastic syndromes undergoing allogeneic hematopoietic stem cell transplantation. Subjects eligible for enrollment were grouped based on the results of the initial myeloid genomic second-generation sequencing, and were given different regimens of maintenance therapy, with the aim of evaluating the efficacy and safety of the maintenance regimen.
CONDITIONS
Official Title
Molecular Genetics Guide the Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 75 years
- Diagnosis confirmed by initial myeloid gene second-generation sequencing
- Classified into one of four genetic subgroups for treatment assignment
- First allogeneic hematopoietic stem cell transplantation done within 30-60 days
- Complete donor chimerism confirmed by STR-PCR
- Complete remission and negative bone marrow flow MRD before maintenance therapy
- No active infection or acute graft-versus-host disease requiring systemic treatment
- Adequate organ function and laboratory values within 7 days before treatment start including liver enzymes, bilirubin, blood counts, kidney function, coagulation, and heart function
- Negative pregnancy test for women of childbearing potential within 7 days before first dose
- Agreement to use effective contraception during study and 180 days after last dose
- Voluntary informed consent and ability to comply with study requirements
You will not qualify if you...
- Change from negative to positive bone marrow or peripheral blood MRD
- Presence of acute or chronic graft-versus-host disease or active infection requiring systemic immunosuppressive therapy
- Clinically significant active cardiovascular disease such as uncontrolled arrhythmias, hypertension, congestive heart failure, NYHA class 3 or 4 heart disease, or recent myocardial infarction within 6 months
- Serious medical conditions limiting participation like uncontrolled diabetes or active autoimmune disease
- Known HIV infection or uncontrolled chronic hepatitis B or C infection
- Neurological or psychiatric disorders
- Inability to understand or comply with the study protocol or provide informed consent
- Investigator judgment that participation is not appropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
X
Xiaoxia Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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