RECRUITING

A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome

Conditions

Myelodysplastic Syndromes Momelotinib Low-risk Myelodysplastic Syndrome MIDAS

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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 clinical trial is to determine if momelotinib is safe and effective for people with low-risk myelodysplastic syndromes (LR-MDS). The trial will also examine how the body processes the drug. The study is comprised of two parts: Part 1: Participants will receive different doses of momelotinib to find the best dose by evaluating effectiveness in improving red blood cell transfusion requirements and safety. Part 2: Participants will receive dose selected from Part 1 to assess its impact on improving red blood cell transfusion requirements and safety in LR-MDS.

Official Title

A Phase 2, Randomized, Open-label, Study of Momelotinib in Participants With Anemia Due to Low-risk Myelodysplastic Syndrome

Quick Facts

Study Start:2025-06-05

Study Completion:2029-03-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06847867

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
* Documented diagnosis of MDS according to the World Health Organization classifications with an Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease, with an overall risk score ≤3.5. * Received prior treatment with Erythropoiesis-stimulating agent (ESA) OR luspatercept for LR-MDS-related anemia that is relapsed/refractory to therapy. Participants intolerant to prior ESA or luspatercept will fulfill this inclusion criterion provided the definition below is met. * Red blood cell transfusion dependence, defined as requiring an average of ≥4 units of Packed red blood cells (pRBC) transfused over an 8-week period during the 16 weeks preceding randomization. Documentation of a participant's transfusion policy during this 16-week period is required. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is capable of giving signed informed consent. * Eastern Cooperative Oncology Group performance status ≤2. * Adequate organ function.	1. Janus kinase (JAK)1/2 inhibitors; ACTRIIb IMiDs (iif ≤1 week of treatment received; provided last dose was ≥8 weeks from randomization 2. ACTRIIb receptor ligand trap other than luspatercept 3. Hypomethylating agents or other disease modifying agents (i.e., IMiDs) and immunosuppressive therapy for MDS 4. ESA within 4 weeks, or 8 weeks for long-acting ESA. 5. Growth factors (i.e., G-CSF, GM-CSF) within 4 weeks. 6. Luspatercept within 8 weeks. 7. Investigational agents within 4 weeks or 5 half-lives, whichever is longer. 8. Corticosteroids for treatment of the underlying disease within 28 days. Supportive care use of steroids for non-MDS indications may be used provided participant is on a stable dose equivalent to ≤10 mg prednisone per day. 9. Other active anti-MDS therapy not otherwise listed within 28 days or 5 half-lives whichever is longer. 10. Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of momelotinib. 11. Has received a live vaccine within 30 days. • Prior allogeneic or autologous stem cell transplant. • Has had any major surgery within 28 days prior to randomization. • Ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, except if the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study. * MDS associated with del 5q cytogenetic abnormality. * Secondary MDS (i.e., MDS that is known to have arisen as the result of chemical injury, treatment with chemotherapy, and/or radiation for other diseases). * Known history of diagnosis of acute myeloid leukemia. * Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia. * Diagnosis of invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, except as noted below: 1. History of an invasive malignancy for which the participant was definitively treated, and in which the participant has been disease free for at least 2 years, and which, in the opinion of the principal investigator and medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted disease under study. 2. Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, and/or in situ breast cancer may be enrolled. 3. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumor, nodes, metastasis \[TNM\] clinical staging system). * Uncontrolled intercurrent illness including, but not limited to: 1. Unstable angina pectoris. 2. Symptomatic congestive heart failure. 3. Uncontrolled cardiac arrhythmia. • QTc interval \>480 milliseconds (msec) (corrected using Fridericia formula). * Is unable to swallow and/or retain oral medications. * Known contraindication or hypersensitivity to momelotinib and its metabolites, or any of their excipients.

Inclusion Criteria

Exclusion Criteria

* Documented diagnosis of MDS according to the World Health Organization classifications with an Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease, with an overall risk score ≤3.5.
* Received prior treatment with Erythropoiesis-stimulating agent (ESA) OR luspatercept for LR-MDS-related anemia that is relapsed/refractory to therapy. Participants intolerant to prior ESA or luspatercept will fulfill this inclusion criterion provided the definition below is met.
* Red blood cell transfusion dependence, defined as requiring an average of ≥4 units of Packed red blood cells (pRBC) transfused over an 8-week period during the 16 weeks preceding randomization. Documentation of a participant's transfusion policy during this 16-week period is required.
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
* Is capable of giving signed informed consent.
* Eastern Cooperative Oncology Group performance status ≤2.
* Adequate organ function.

1. Janus kinase (JAK)1/2 inhibitors; ACTRIIb IMiDs (iif ≤1 week of treatment received; provided last dose was ≥8 weeks from randomization
2. ACTRIIb receptor ligand trap other than luspatercept
3. Hypomethylating agents or other disease modifying agents (i.e., IMiDs) and immunosuppressive therapy for MDS
4. ESA within 4 weeks, or 8 weeks for long-acting ESA.
5. Growth factors (i.e., G-CSF, GM-CSF) within 4 weeks.
6. Luspatercept within 8 weeks.
7. Investigational agents within 4 weeks or 5 half-lives, whichever is longer.
8. Corticosteroids for treatment of the underlying disease within 28 days. Supportive care use of steroids for non-MDS indications may be used provided participant is on a stable dose equivalent to ≤10 mg prednisone per day.
9. Other active anti-MDS therapy not otherwise listed within 28 days or 5 half-lives whichever is longer.
10. Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of momelotinib.
11. Has received a live vaccine within 30 days. • Prior allogeneic or autologous stem cell transplant. • Has had any major surgery within 28 days prior to randomization. • Ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, except if the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.
* MDS associated with del 5q cytogenetic abnormality.
* Secondary MDS (i.e., MDS that is known to have arisen as the result of chemical injury, treatment with chemotherapy, and/or radiation for other diseases).
* Known history of diagnosis of acute myeloid leukemia.
* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia.
* Diagnosis of invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, except as noted below:
1. History of an invasive malignancy for which the participant was definitively treated, and in which the participant has been disease free for at least 2 years, and which, in the opinion of the principal investigator and medical monitor, is not expected to affect the evaluation of the effects of the study intervention on the currently targeted disease under study.
2. Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, and/or in situ breast cancer may be enrolled.
3. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumor, nodes, metastasis \[TNM\] clinical staging system).
* Uncontrolled intercurrent illness including, but not limited to:
1. Unstable angina pectoris.
2. Symptomatic congestive heart failure.
3. Uncontrolled cardiac arrhythmia. • QTc interval \>480 milliseconds (msec) (corrected using Fridericia formula).
* Is unable to swallow and/or retain oral medications.
* Known contraindication or hypersensitivity to momelotinib and its metabolites, or any of their excipients.

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center

CONTACT

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

Study Locations (Sites)

GSK Investigational Site

Canton, Ohio, 44718

United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

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 Date2025-06-05

Study Completion Date2029-03-06

Study Record Updates

Study Start Date2025-06-05

Study Completion Date2029-03-06

Terms related to this study

Keywords Provided by Researchers

Momelotinib
Low-risk Myelodysplastic Syndrome
MIDAS

Additional Relevant MeSH Terms

Myelodysplastic Syndromes