Experimental combo aims to outsmart resistant blood cancer
NCT ID NCT06923488
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests whether adding leflunomide to the standard drug decitabine is safe and effective for people with myelodysplastic syndromes (MDS) that have returned or not responded to prior treatment. About 26 adults will receive the combination in cycles. The main goal is to find the best dose with manageable side effects, while also checking if the cancer goes into remission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- leflunomide and decitabine
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with myelodysplastic syndromes that have stopped responding to standard therapy.
- What could go wrong
- This is an early-phase trial with only 26 participants, so results may not apply to everyone. The combination may cause side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient has pathologically confirmed diagnosis of MDS * Patient has currently measurable disease meeting the following criteria: * Bone marrow biopsy with more than 5% blasts, AND * Absolute neutrophil count (ANC) less than 1,000/mcL, and/or platelet count less than 100,000/mcL and/or hemoglobin levels less than 10g/dL * Patient has received one prior treatment with a DNA methyltransferase inhibitor (DNMTi), also commonly called hypomethylating agent (HMA). Patients whose MDS has IDH1/IDH2 mutations should have received at least one available IDH1/IDH2 inhibitor * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Patient has the following required baseline laboratory data (eligibility can be based on local lab results): * Total serum bilirubin level less than or equal to 2 times ULN * Estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2 * Patients who have undergone alloHSCT are eligible if they are more than 28 days post stem cell infusion, have no evidence of GVHD \> Grade 1, and are more than a week off all immunosuppressive therapy * If a female of childbearing potential, the patient has a negative serum or urine pregnancy test result within 7 days prior to the first dose of treatment. Women of non-childbearing potential are those who are postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy * If female of childbearing potential or a male patient, patient agrees to use an effective contraceptive method from the time of informed consent, during the course of the study, and for 3 months following the last dose of treatment * Patient understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution Exclusion Criteria: * Patients receiving any other investigational agents, or concurrent chemotherapy or immunotherapy * Patients with progression to acute myeloid leukemia * Patients with other malignancies requiring systemic chemotherapy, immunotherapy or targeted therapy in the last four weeks * Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms) * Patients with active or latent tuberculosis * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that per Principal Investigator's judgment would limit compliance with study requirements * Females who are pregnant or breast feeding * Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West Virginia University Cancer Institute
RECRUITINGMorgantown, West Virginia, 26506, United States
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