Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-13

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will examine quality of life, experiences, and unmet needs among individuals diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent and among individuals with suspected myelodysplastic syndromes with unexplained anemia in Japan

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mean Platelet Volume and Its Relation to Risk Stratification of Myelodysplastic Syndromes

NCT05204953

Myelodysplastic Syndromes

COMPLETED

Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes

NCT03906695

Lower-risk Myelodysplastic

ACTIVE_NOT_RECRUITING PHASE1

Plasmatic L-AScorbic Acid in MYelodyplastic Syndroms and Controls

NCT02809222

Myelodysplastic Syndrome Secondary Acute Myeloid Leukemia

COMPLETED NA

A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-naïve Patients With Higher-risk Myelodysplastic Syndrome (MDS)

NCT05709093

Myelodysplastic Syndromes(MDS)

TERMINATED PHASE3

Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS

NCT03502668

Myelodysplastic Syndromes

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myelodysplastic Syndrome (MDS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

Low Risk Myelodysplastic Syndrome erythropoietin stimulating agent naïve and non-transfusion dependent

Health-related quality of life questionnaires

Intervention Type OTHER

Questionnaires include:

EORTC-QLQ C30 FACT-An PGI-S EQ-5D-5L

Qualitative interviews

Intervention Type OTHER

For participants that meet eligibility criteria

Cohort 2

Suspected Low Risk Myelodysplastic Syndrome with unexplained anemia

Health-related quality of life questionnaires

Intervention Type OTHER

Questionnaires include:

EORTC-QLQ C30 FACT-An PGI-S EQ-5D-5L

Qualitative interviews

Intervention Type OTHER

For participants that meet eligibility criteria

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Health-related quality of life questionnaires

Questionnaires include:

EORTC-QLQ C30 FACT-An PGI-S EQ-5D-5L

Intervention Type OTHER

Qualitative interviews

For participants that meet eligibility criteria

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Low Risk Myelodysplastic Syndromes (LR MDS) erythropoietin stimulating agent (ESA) naïve non-transfusion dependent (NTD) patrticipants: identified with confirmed via bone marrow aspirate and \< 5% blasts in bone marrow. Lower-risk is defined by International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R), as follows:

* Very low, low, or intermediate-risk (score ≤ 3.5) as assessed by IPSS-R
* Low or intermediate-1 (score ≤ 1) as assessed by IPSS
2. Unexplained anemia with suspected MDS: identified anemia with general anemia (iron/vitamin deficiency, bleeding, renal, etc.) excluded
3. Participants with hemoglobin in the most recent blood test \< 10.0 g/dl, or the average of hemoglobin \< 10.0g/dl in the most recent 2 blood tests conducted within 30 days prior to enrollment in this study
4. Participants who are ≥ 18 years of age at the time of signing the informed consent form.
5. Participants who are able and willing to provide informed consent.
6. Participants who are able to complete the protocol requirements.

1\. Participants with severity scores of "moderate" or greater on at least one Patient Global Impression-Severity (PGI-S) item.

Exclusion Criteria

Patients meeting the following criteria will be excluded:

1. Participants who have difficulty obtaining informed consent or execution of this study because of insufficient Japanese language proficiency.
2. Participants who are considered to have difficulty answering HRQoL questionnaires and/or responding to questions during cognitive interview
3. Participants who received red-blood cell transfusion (RBC-T) within 16 weeks prior to enrollment.

Note: RBC-T of 1 to 2 units within the 16 weeks prior to enrollment are allowed, provided those 1-2 RBC-T units are administered for an acute event/illness (i.e., surgical procedure, bleeding, infection) or presence of comorbidity (including cardiovascular, pulmonary, cerebrovascular), and not for the treatment of low hemoglobin (with or without symptoms) alone.
4. Participants who received prior drug treatment related to anemia; drugs include the following: erythropoiesis stimulating agent, erythroid maturation agent, hypomethylating agent, immunomodulatory drugs, immuno-suppressive agent.
5. Participants with myelodysplastic/myeloproliferative neoplasms (MDS/MPN) according to World Health Organization (WHO) 2016 classification (i.e., chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, breakpoint cluster region-Abelson 12, juvenile myelomonocytic leukemia, MDS/MPN unclassifiable).
6. Participants with secondary MDS (i.e., MDS that is known to have arisen as a result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).
7. Participants with a known history of diagnosis of acute myeloid leukemia.
8. Participants with major surgery within 8 weeks prior to enrollment. Patients must have completely recovered from any previous surgery prior to enrollment.
9. Participants with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venus thrombosis within 6 months prior to enrollment. Note: prior superficial thrombophlebitis is not an exclusion criterion.
10. Participants who have any condition or receive concomitant medication that confounds the ability to interpret data from the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No