Actively Recruiting
A Single-arm, Prospective Study of a Cladribine-Bridged Lisaftolax and Busulfan Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed/Refractory Myelodysplastic Syndromes and Acute Myeloid Leukemia in Elderly Patients
Led by The First Affiliated Hospital of Soochow University ยท Updated on 2026-04-15
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a conditioning treatment regimen for elderly patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). This study focuses on the Clad-LABu regimen, which combines cladribine bridged lisaftolax and busulfan, aiming to improve transplant outcomes and reduce toxicity in allogeneic hematopoietic stem cell transplantation (HSCT). The trial is motivated by the poor prognosis and rising incidence of AML in older adults and the need for better tolerability and efficacy in this population. Participants will receive the Clad-LABu conditioning regimen before undergoing allogeneic HSCT. The regimen includes intravenous cladribine and cytarabine, oral lomustine and lisaftoclax, subcutaneous or intravenous azacitidine or decitabine, and intravenous busulfan administered over specific days before transplantation. This single-arm, prospective study involves 30 patients who will be treated and monitored for their response to this conditioning approach. During the study, patients will be closely observed for survival rates without relapse and overall survival within one year post-transplant. Researchers will also track neutrophil and platelet recovery, transplant-related mortality, incidence and severity of graft-versus-host disease, and relapse rates within the first year. Assessments include clinical evaluations and laboratory tests to monitor organ function and treatment effects, with ongoing safety and efficacy monitoring throughout the study period.
CONDITIONS
Brief Title
A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Diagnosed with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) according to 2022 WHO criteria
- Suitable cardiac, liver, and kidney function within specified laboratory limits
- Availability of a suitable allogeneic donor
- Expected survival of at least 1 month
- Karnofsky Performance Status (KPS) of 60% or higher and ECOG performance status of 2 or less
- Ability to understand the study and provide informed consent
You will not qualify if you...
- History of serious allergic reactions to study drugs
- History of immunodeficiency or organ transplantation
- Recent severe cardiovascular events within 6 months
- Recent major surgery within 4 weeks prior to enrollment
- Active infections requiring systemic treatment, including HIV and hepatitis B or C
- Active central nervous system leukemia infiltration
- Pregnant or breastfeeding
- Participation in another clinical study
- Other conditions judged by the investigator to make the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Approximately 14 days
Participants receive the Clad-LABU conditioning regimen followed by allogeneic hematopoietic stem cell transplantation.
1 treatment period with multiple infusions and oral medications from day -14 to day -3
Duration - Up to 1 year following transplantation
Participants are monitored for efficacy outcomes and adverse events including survival, engraftment, transplant-related mortality, and graft-versus-host disease.
Regular follow-up visits during the year after transplantation
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
X
Xiaojin Wu
D
Depei Wu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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