Actively Recruiting
Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies
Led by University of Alabama at Birmingham · Updated on 2026-03-04
20
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the safety of adding Decitabine and Venetoclax to patients undergoing reduced intensity allogenic transplantation for treatment of hematologic malignances with Fludarabine and Melphalan.
CONDITIONS
Official Title
Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Have a related or unrelated peripheral blood stem cell donor meeting specified HLA matching and donation criteria
- Candidate for reduced intensity preparative regimen due to age 60 or older, HCT-CI score 4 or higher, or physician assessment of high myeloablative toxicity risk
- Cardiac ejection fraction over 40%
- Creatinine clearance greater than 50 mL/min
- Pulmonary function with DLCO and FEV1 at least 50%
- Liver function with total bilirubin less than 1.5 times upper normal limit (or up to 3 mg/dl if diagnosed with Gilbert's Disease) and ALT/AST less than 2.5 times upper normal limit
- Female subjects must use two effective contraception methods or abstain from heterosexual intercourse unless postmenopausal or surgically sterilized
- Male subjects or their partners must use effective barrier contraception or abstain from heterosexual intercourse
- Karnofsky performance status of 70 or higher
- Diagnosis of AML with active or adverse risk disease, MDS with high risk or blasts, or MDS/MPN with blasts and spleen size under 22 cm
- Willing and able to sign informed consent and follow study protocol
You will not qualify if you...
- Autologous stem cell transplant within the last 3 months
- Previous allogeneic stem cell transplant
- Uncontrolled angina, severe uncontrolled arrhythmias, or acute EKG abnormalities
- Known allergy to Decitabine, Venetoclax, or ATG
- Pregnant or breastfeeding
- HIV infection or positive HIV serology
- Current uncontrolled infections with progressing symptoms
- Non-hematologic cancer within the past 3 years except certain skin or cervical cancers; cancers in remission for less than 5 years must be approved
- Participation in another investigational drug study within last 28 days
- Documented liver cirrhosis confirmed by imaging or biopsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
O
Omer Jamy, MD
CONTACT
M
Margaret A Thomas, MPH
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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