RECRUITING

Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes

Conditions

Myelodysplastic Syndromes relapsed or refractory

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this interventional clinical trial is to evaluate the safety and tolerability of leflunomide in combination with decitabine as treatment for patients with relapsed or refractory myelodysplastic syndromes (R/R MDS). The main question this study aims to answer are to evaluate and estimate the maximum tolerated doses and/or biologically active doses of the combination of leflunomide-decitabine in participants. Decitabine will be administered at a dose of 20 mg/m2 by continuous intravenous infusion over one hour repeated daily for 5 days with repeating cycle every 4 weeks. Leflunomide is administered orally at 10 to 20 mg once daily (without a loading dose) for 14 to 21 days, as part of a 28-day treatment cycle in adult subjects with R/R MDS. After 12 cycles (study duration) responding patients can continue progression with the assigned doses.

Official Title

Phase I/II Study of Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory (R/R) Myelodysplastic Syndromes (MDS)

Quick Facts

Study Start:2025-08

Study Completion:2028-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06923488

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Konstantinos Sdrimas, MD

CONTACT

304-598-4520

Konstantinos.sdrimas1@hsc.wvu.edu

Principal Investigator

Konstantinos Sdrimas, MD

PRINCIPAL_INVESTIGATOR

West Virginia University

Study Locations (Sites)

West Virginia University Cancer Institute

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: West Virginia University

Konstantinos Sdrimas, MD, PRINCIPAL_INVESTIGATOR, West Virginia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2028-10

Study Record Updates

Study Start Date2025-08

Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

relapsed or refractory

Additional Relevant MeSH Terms

Myelodysplastic Syndromes