A Phase 2a Study of HT-6184 in Subjects With IPSS-R Very Low, Low or Intermediate Risk MDS and An… (NCT07052006) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2a Study of HT-6184 in Subjects With IPSS-R Very Low, Low or Intermediate Risk MDS and Anemia
India37 participantsStarted 2023-12-09
Plain-language summary
This research is being conducted to asses if HT-6184 is effective in the treatment of Very Low, Low, or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia.
The study includes a 28-day Screening Period followed by a 16- or 32-week Treatment Period.
Participants will be monitored at each cycle for drug tolerance, safety, and hematological response. A response assessment will occur after 16 weeks of study treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 18 years of age.
. Signed Informed Consent Form (ICF).
. Adequate organ function.
. A documented diagnosis of MDS or non-proliferative Myelodysplastic/myeloproliferative neoplasm (MDS/MPN).
. Less than 10% bone marrow myeloblasts.
. Refractory or intolerant of, or ineligible for treatment with an erythroid stimulating agent (ESA).
. Prior ESA treatment must have been discontinued ≥ 2 weeks prior to date of study treatment.
. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.