Key Highlights
- Investigational Treament
- Transfusion Reduction
- Adults with very low, low, or intermediate risk MDS
Designed for patients with transfusion-dependent anemia associated with MDS.
Clinical Trial #23586: Elritercept for Myelodysplastic Syndromes (MDS)
Refer eligible patients for a Phase 3 trial called RENEW for adults with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) who require regular red blood cell transfusions.
A Potential Treatment to Reduce Red Blood Cell Transfusions
The RENEW study is a randomized, double-blind, placebo-controlled trial comparing elritercept with placebo. Participants will be assigned to a study group to help researchers evaluate the treatment's effects and safety.
Early Clinical Results Show Promise
Results from Phase 2 study are encouraging.
Researchers reported that 41.3% of evaluable participants achieved at least 8 consecutive weeks without red blood cell transfusions during the first 24 weeks of elritercept treatment. The study included patients with different transfusion burdens, including some with high transfusion needs.
What does trial participation look like for patients?
- Submit referral request and send patient records to Moffitt
- Patients will be pre-screened for basic eligibility by the clinical research coordinator
- Initial appointment with Dr. Hansen
- Workup and clinical screening appointments
- Following enrollment in the trial, patient is scheduled to receive subcutaneous injections once every 4 weeks for 24 weeks
Not sure if your patient qualifies? Contact the Clinical Research Coordinator for rapid eligibility review: Mary.Mickelson@moffitt.org
Which Patients May Be Eligible?
Inclusion Criteria Summary:
- Age 18 or older
- Diagnosis of MDS: Very low-, low- or intermediate-risk disease according to the Revised International Prognostic Scoring System (IPSS-R), confirmed through a bone marrow evaluation
- Transfusion-dependent anemia: Red blood cell transfusion needs meeting the study's requirements during the 16 weeks before randomization
- Prior anemia treatment: Previously treated with an erythropoiesis-stimulating agent (ESA) without adequate benefit, unable to tolerate ESA treatment, or considered unlikely to respond to ESA treatment
- Bone marrow blast count: Less than 5% blasts on the screening bone marrow evaluation
- Functional status: Eastern Cooperative Oncology Group (ECOG) performance status of 0–2
- Ability to participate: Willing and able to comply with study procedures and follow-up requirements
- Contraception requirements: Participants who meet the study's reproductive criteria must agree to use highly effective contraception as required by the protocol
Exclusion Criteria Summary:
- MDS with a del(5q) abnormality or therapy-related MDS
- Another known cause of anemia, such as iron, vitamin B12 or folate deficiency, or hemolytic anemia
- History of acute myeloid leukemia (AML)
- Certain significant cardiovascular conditions or a recent stroke, deep vein thrombosis or pulmonary embolism
- Certain active infections or a history of HIV, hepatitis B or hepatitis C infection
- Prior treatment with elritercept, luspatercept or sotatercept
- Prior use of certain treatments for MDS, including hypomethylating agents, lenalidomide, imetelstat or immunosuppressive therapy
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Expenses Reimbursed
Travel, lodging and meals expenses are covered by the trial sponsor from the first visit/screening through the 2 year follow up period via reimbursement
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Follow-up Care
There are 2 years of active follow-up care. This is followed up by care visits every 6 months until 15 years post therapy.
Partner with Moffitt
A referral for a clinical trial means we will work together to give your patient the best chance at beating their cancer.
This trial shows promise for a treatment to reduce the burden of repeated blood transfusions. The potential for fewer treatment visits and less disruption to everyday life would bring significant relief for patients with MDS.
Rami Komrokji, MD
Principal Investigator
Have a patient you think would be a candidate for this clinical trial?
If you have questions for the Research Coordinator about the trial, please contact Mary.Mickelson@moffitt.org.
For questions about referring your patient or to learn more about Moffitt you can speak with a Physician Liaison: