Actively Recruiting
Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)
Led by Rigel Pharmaceuticals · Updated on 2025-10-21
86
Participants Needed
15
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1b Study of R289 in Patients with Lower-risk Myelodysplastic Syndromes (LR MDS)
CONDITIONS
Official Title
Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older at the time of signing the informed consent
- Definitive diagnosis of MDS with very low, low, or intermediate-1 risk (IPSS-R 6 3.5) and 6 5% bone marrow myeloblasts
- Relapsed, refractory/resistant, intolerant, or inadequate response to prior therapies like EPOs, luspatercept, or hypomethylating agents; patients with del (5q) must have failed lenalidomide
- DOSE ESCALATION PHASE: symptomatic anemia with hemoglobin < 9.0 g/dL and no RBC transfusion within 16 weeks of registration or RBC transfusion dependent receiving 6 2 units PRBCs within 8 weeks in the previous 16 weeks for hemoglobin < 9.0 g/dL
- DOSE EXPANSION PHASE: relapsed, refractory to or ineligible for ESAs with prior approved therapies for LR-MDS and RBC transfusion dependent
- EXPLORATORY PHASE 1b COHORT: transfusion-dependent LR-MDS refractory or intolerant to, or ineligible for ESAs; no prior therapy for MDS; no del 5q cytogenetic abnormality; RBC transfusion dependent
- Documented marrow iron stores or transferrin saturation > 20% or serum ferritin > 100 ng/100 mL
- ECOG performance status 0 to 2 at screening
- Adequate organ function: AST and ALT 6 1.5 times upper limit of normal, total bilirubin 6 1.5 times upper limit of normal; creatinine clearance > 60 mL/min or blood creatinine < 1.5 mg/dL
You will not qualify if you...
- Prior MDS treatment ended less than 4 weeks before study treatment
- Anemia caused by iron, B12 or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding
- MDS secondary to radiotherapy, chemotherapy, or immunotherapy for other diseases
- Diagnosis of chronic myelomonocytic leukemia
- History of uncontrolled seizures
- Uncontrolled bacterial or viral infections including HIV, hepatitis B or C
- History of other malignancies that could affect study compliance or results, except certain treated cancers in remission for 2 or more years
- History or active significant disorders affecting heart, lungs, gastrointestinal, kidney, liver, nervous system, psychiatric, musculoskeletal, genitourinary, skin, or other systems that could affect study or drug metabolism
- Prior autologous or allogeneic stem cell transplantation
- Significant prolongation of QT/QTc interval or risk factors for Torsades de Pointes
- Receiving concurrent chemotherapy, radiotherapy, or immunotherapy within 2 weeks of study treatment or unresolved toxicity from prior treatment
- Use of medications that prolong QT/QTc interval or are strong CYP3A or CYP2B6 inhibitors or inducers during study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
3
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Not Yet Recruiting
4
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
5
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Withdrawn
6
WashU Medicine
St Louis, Missouri, United States, 63110
Not Yet Recruiting
7
Oncology Clinical Research Referral Office
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 09083
Withdrawn
9
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
10
Duke Cancer Institute
Durham, North Carolina, United States, 27705
Not Yet Recruiting
11
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
13
University of Texas, Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
14
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Intermountain Healthcare
Salt Lake City, Utah, United States, 84009
Actively Recruiting
Research Team
S
Strait Hicklin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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