Actively Recruiting
Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant
Led by Washington University School of Medicine · Updated on 2026-03-23
209
Participants Needed
1
Research Sites
602 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
T
Taiho Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators hypothesize that early measurable residual disease (MRD)-guided pre-emptive therapy with decitabine + cedazaridine (DEC-C) will decrease the risk of progression in post-transplant myelodysplastic syndromes (MDS) patients with persistent mutations (molecular MRD). To detect molecular MRD, the investigators will perform ultra-deep, error-corrected panel-based sequencing (MyeloSeq-HD) at Day 30 in post-transplant MDS patients. The investigators will treat patients with detectable molecular MRD with DEC-C to determine if pre-emptive, MRD-guided therapy with DEC-C decreases relapse rates and improves progression-free survival.
CONDITIONS
Official Title
Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myelodysplastic syndromes (MDS) based on WHO 2016 classification
- Received an allogeneic hematopoietic cell transplant
- Age between 18 and 75 years
- Completed gene panel testing prior to transplant with at least one somatic mutation detected
- Willing to comply with treatment assignment based on MRD test results
- Not currently receiving investigational agents
- Ability to understand and sign informed consent
- For DEC-C intervention arm: detectable somatic variants at Day 30 post-transplant with variant allele frequency 0.2%, Days 42-100 post-transplant, bone marrow myeloblasts = 5%, ANC 1.0 x 10^9/L, platelets 50 x 10^9/L
- Controlled GVHD = Grade 2
- ECOG performance status = 2
- Adequate liver and kidney function (bilirubin 1.5 x IULN, AST/ALT 3.0 x IULN, creatinine clearance 30 mL/min)
- Women and men must agree to use contraception during and for 6 months after study participation
- For observation arm: bone marrow myeloblasts = 5% or not eligible for intervention arm
You will not qualify if you...
- Currently receiving other investigational agents
- History of allergic reactions to compounds similar to DEC-C or study agents
- Taking drugs metabolized by cytidine deaminase concurrently
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, or arrhythmia
- Pregnant or breastfeeding
- Women of childbearing potential must have negative pregnancy test within 10 days before starting DEC-C
- Active GVHD grade 3 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
M
Meagan Jacoby, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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