OncoMatch/Clinical Trials/NCT03326310
Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
Is NCT03326310 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Azacitidine and Selumetinib for chronic myeloid leukemia.
Treatment: Azacitidine · Selumetinib — This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when combined with the standard dose of azacitidine. Treatment will begin within 28 days of screening procedures. Treatment will continue indefinitely, provided that the patient continues to derive benefit. A patient will be taken off study for reasons described in detail in section 3.12 including disease progression, unacceptable toxicity, inter-current illness, withdrawal of consent, or at the discretion of the investigator. Patients will be followed for 12 weeks after the last dose of study drug, until any study treatment related toxicities have stabilized, or until death. The total duration of the study is expected to be approximately 24 months.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: MEK inhibitor
No history of prior exposure to a MEK inhibitor
Cannot have received: anti-cancer therapy
Exception: hydroxyurea permitted if clinically indicated to keep WBC <30,000/uL; may be continued through first cycle
Receipt of any anti-cancer therapy within 14 days prior to study entry, with the exception of hydroxyurea
Lab requirements
Kidney function
serum creatinine ≤ 1.5 x ULN or creatinine clearance >30 mL/min (Cockroft-Gault equation)
Liver function
conjugated bilirubin ≤ 2 x ULN; AST and ALT ≤ 3 x ULN
Adequate renal function, defined as serum creatinine ≤ 1.5 x ULN or creatinine clearance >30 mL/min; Adequate liver function, defined as conjugated bilirubin ≤ 2 x ULN as well as aspartate transaminase (AST) and alanine aminotransaminase (ALT) ≤ 3 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Chicago · Chicago, Illinois
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