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R289 for Myelodysplastic Syndrome

Phase 1 & 2
Recruiting
Research Sponsored by Rigel Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have definitive diagnosis of MDS with very low, low, or intermediate-1 risk (International Prognostic Scoring System (IPSS)-R ≤ 3.5) and ≤5% bone marrow myeloblasts
Must have adequate organ function, defined as: Hepatic function: aspartate amino transferase (AST) or alanine aminotransferase (ALT) ≤ 1.5 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN, Renal function defined as creatinine clearance > 60 mL/min (using Cockcroft-Gault), or blood creatine < 1.5 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights

Study Summary

This trialtests a drug to treat MDS and how it works with existing treatments to reduce disease symptoms.

Who is the study for?
This trial is for adults over 18 with lower-risk Myelodysplastic Syndromes (LR MDS) who haven't responded well to other treatments like TPOs, EPOs, luspatercept, and HMAs. They should have low bone marrow myeloblasts and issues like needing blood transfusions or having low platelet counts. Participants need good liver and kidney function and can't join if they've had recent MDS treatment or certain health problems.Check my eligibility
What is being tested?
The study tests R289 Na in patients with LR MDS to see its safety and effectiveness. It's a Phase 1b trial which means it's early in the testing process focusing on how people react to the drug at different doses.See study design
What are the potential side effects?
While specific side effects of R289 Na aren't listed here, similar drugs may cause fatigue, nausea, blood count changes, or organ inflammation. Side effects depend on individual reactions to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My MDS is classified as very low, low, or intermediate-1 risk with ≤5% bone marrow blasts.
Select...
My liver and kidney functions are within normal ranges.
Select...
I am 18 years old or older.
Select...
I need regular blood transfusions or have had a low platelet count in the last 8 weeks.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability
Secondary outcome measures
Characterize pharmacokinetics (PK)
Participants with red blood cell transfusion independence by Week 24
Other outcome measures
Characterize pharmacodynamic (PD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Dose Level 1: 250mg PO qd Dose Level 2: 500mg PO qd Dose Level 3: 750 mg PO qd and 1000 mg PO qd

Find a Location

Who is running the clinical trial?

Rigel PharmaceuticalsLead Sponsor
31 Previous Clinical Trials
3,814 Total Patients Enrolled

Media Library

R906289 Monosodium (R289 Na) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05308264 — Phase 1 & 2
Myelodysplastic Syndrome Research Study Groups: Experimental
Myelodysplastic Syndrome Clinical Trial 2023: R906289 Monosodium (R289 Na) Highlights & Side Effects. Trial Name: NCT05308264 — Phase 1 & 2
R906289 Monosodium (R289 Na) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05308264 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this trial recruiting?

"The trial sponsor, Rigel Pharmaceuticals, demands a total of 22 participants who meet the study's prerequisites. The clinical research will be held at multiple sites including Mount Sinai Medical Centre in Miami Beach and Ichan School of Medicine at Mount Sinai located in New york City."

Answered by AI

How many locations within this city are running the trial?

"Currently, this trial is recruiting patients from a number of medical centres such as Mount Sinai Medical Center in Miami Beach, Ichan School of Medicine at Mount Sinai in New york City, and Rutgers Cancer Institute of New jersey located in New Brunswick. Additionally, there are 4 other sites participating."

Answered by AI

Could you please confirm whether enrollment for this trial is still open?

"Affirmative, the research posted on clinicaltrials.gov is still recruiting participants for its medical trial. Initially uploaded to the website in September 12th 2022 and last updated October 26th 2022, this study requires 22 individuals from 4 distinct sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of R289 in Participants With Lower-risk Myelodysplastic Syndromes (LR MDS)
2022. "Study of R289 in Participants With Lower-risk Myelodysplastic Syndromes (LR MDS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05308264.
~13 spots leftby May 2025
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