Actively Recruiting
Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
Led by Remedy Plan, Inc. · Updated on 2026-03-25
24
Participants Needed
2
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main goals of this study are to learn if RPT1G is safe and tolerable and to determine the best dose and schedule of RPT1G for patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).
CONDITIONS
Official Title
Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status 642
- Histological confirmation of relapsed and/or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) as per defined criteria
- Prior appropriate standard of care therapy received or declined, as judged by the investigator
- Adequate liver function with AST and ALT 642.5 x upper limit of normal, and total bilirubin <2 x upper limit of normal (adjusted for Gilbert's syndrome if applicable)
- Adequate renal function with creatinine clearance >50 mL/min calculated by Cockcroft-Gault equation
You will not qualify if you...
- No evidence of blood or marrow involvement
- Diagnosis of acute promyelocytic leukemia
- Symptomatic central nervous system involvement by AML
- Clinical signs or symptoms of leukostasis requiring urgent therapy
- Active infections
- Radiotherapy within 14 days prior to first RPT1G dose
- Ongoing complications from prior therapy
- Prior or concurrent malignancy
- Any condition, therapy, or comorbidity that makes participation not in the patient's best interest
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eunice Vukosavljevic, CP, Director of Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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