St Louis, MONCT04742634Now EnrollingIRB Ready

Myelodysplastic Syndromes Clinical Trial in St Louis, MO

Access cutting-edge myelodysplastic syndromes treatment through this phase 1/2 clinical trial at a research site in St Louis. Study-provided care at no cost to qualified participants.

Sponsored by Washington University School of Medicine

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Expert Care in St Louis

Access myelodysplastic syndromes specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related myelodysplastic syndromes treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to St Louis

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit St Louis site if eligible
  4. 4Begin participation

About This Myelodysplastic Syndromes Study in St Louis

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.

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

are not met.
Not currently receiving any investigational agents.
Ability to understand and willingness to sign an IRB-approved written informed consent document (or that of legally authorized representative, if applicable). Eligibility Criteria for Step 2 Step 2A Inclusion Criteria (DEC-C Intervention Arm)
One or more somatically acquired variants that were present prior to transplant detected by the MyeloSeq-HD panel at Day 30 post-transplant, with a variant allele frequency of ≥ 0.2%
Within Days 42-100 post-transplant.
≤ 5 % bone marrow myeloblasts on the Day 30 post-transplant biopsy.
Absolute neutrophil count (ANC) ≥ 1.0 X 109/L and platelets ≥ 50 X 109/L.
Only patients with adequately controlled GVHD ≤ Grade 2 are eligible for the DEC-C intervention arm. Patients with active grade 3 or higher GVHD are ineligible for the DEC-C intervention arm.
ECOG performance status ≤ 2
Adequate renal and hepatic function as described below:
Total bilirubin ≤ 1.5 x IULN
AST(SGOT)/ALT(SGPT) ≤ 3.0 IULN
Creatinine clearance ≥ 30 mL/min using Cockcroft-Gault Formula below: CrCl = \[(140-age) x body weight in kg\]/(serum creatinine in mg/dL x 72) x 0.85 if female \*NOTE: If, in the opinion of the treating physician, bilirubin is elevated secondary to hemolysis or Gilbert's disease, the patient may be eligible after discussion with the Washington University PI
Decitabine has been shown to be teratogenic in animal studies and use of IV decitabine in the first trimester of pregnancy has been associated with major birth defects. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study. Step 2B Inclusion Criteria (Observation Arm)
EITHER ≤ 5 % bone marrow myeloblasts on the Day 30 post-transplant biopsy OR enrolled in the study with \> 5% bone marrow myeloblasts on the Day 30 post-transplant biopsy but not meeting eligibility criteria for the intervention arm.
Not receiving any investigational agents. Step 2A

Exclusion Criteria

Currently receiving any other investigational agents.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to DEC-C or other agents used in the study.
Concomitant administration of drugs metabolized by cytidine deaminase
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum/urine pregnancy test no more than 10 days prior of the start of the first cycle of DEC-C.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT04742634) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Myelodysplastic Syndromes Treatment Options in St Louis, MO

If you're searching for myelodysplastic syndromes treatment options in St Louis, MO, this clinical trial (NCT04742634) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced myelodysplastic syndromes specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all myelodysplastic syndromes clinical trials near you to find additional studies recruiting in your area.

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