OncoMatch/Clinical Trials/NCT04077307
A Study in Leukemia Patients With Karonudib
Is NCT04077307 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Karonudib for leukemia.
Treatment: Karonudib — The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of hematological malignancies. Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard of care treatments
The patient has received standard of care treatments and has refractory or relapsed or progressive disease with no suitable standard of care options available.
Lab requirements
Blood counts
Platelet count ≥10 x 10^9/L (can be supported by platelet transfusion)
Kidney function
The calculated GFR is at least 30 ml/min using Cockcroft-Gault method
Liver function
Total bilirubin < 3 x ULN (does not apply to patients with Gilberts Syndrome); AST and ALT ≤ 5 x ULN
Cardiac function
Normal left ventricular ejection fraction (LVEF) based on institutional ranges
Adequate hepatic and renal function defined as: Total bilirubin < 3 x ULN (does not apply to patients with Gilberts Syndrome); AST and ALT ≤ 5 x ULN; The calculated GFR is at least 30 ml/min using Cockcroft-Gault method. Platelet count ≥10 x 10^9/L. (Can be supported by platelet transfusion). Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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