Actively Recruiting
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics
Led by medac GmbH · Updated on 2025-12-02
36
Participants Needed
4
Research Sites
147 weeks
Total Duration
On this page
Sponsors
M
medac GmbH
Lead Sponsor
S
Synteract, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aim is to assess, if treosulfan pharmacokinetics are influenced by declined renal function and by race/ethnicity of patients. The study also aims to determine an appropriate safe dose of treosulfan, when patient's renal function is impaired. The participants of this study are undergoing allogenic hematopoietic stem cell transplantation for treatment of acute myeloid leukemia or myelodysplastic syndrome.
CONDITIONS
Official Title
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years with acute myeloid leukemia or myelodysplastic syndrome eligible for treosulfan-based conditioning before allogeneic hematopoietic stem cell transplantation
- Have an available matched or haploidentical donor with specified HLA matching criteria
- Karnofsky Index of at least 60 percent
- Creatinine clearance of 30 mL/min or higher
- Willing to use effective birth control during treatment and for at least 6 months after if of childbearing potential
- Negative pregnancy test if female of childbearing potential
- Provided written informed consent
You will not qualify if you...
- Severe renal impairment (creatinine clearance below 30 mL/min), dialysis, or history of kidney transplant
- Severe lung impairment or need for oxygen supplementation
- Moderate or severe liver impairment or chronic liver disease
- Known coronary artery disease, heart problems including arrhythmias and heart failure (NYHA Class II or higher)
- Prolonged QTc interval (above specified limits for men and women)
- Active cancer involvement in the central nervous system
- HIV positive or active uncontrolled infections including fungal, viral liver infections, or COVID-19
- More than one prior allogeneic hematopoietic stem cell transplantation
- Pleural effusion or ascites over 1.0 liters
- Pregnant or breastfeeding
- Uncontrolled or severe other medical conditions
- Known allergy to treosulfan, fludarabine, or related substances, or DNA repair disorders
- Participation in other experimental drug trials within 4 weeks before baseline visit (except COVID-19 vaccine trials)
- Non-cooperative behavior or lack of compliance
- Psychiatric conditions impairing informed consent
AI-Screening
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Trial Site Locations
Total: 4 locations
1
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Withdrawn
3
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
4
VCU Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
C
Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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