Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

{ "Selumetinib and Azacitidine for High-Risk Chronic Blood Cancers", "This study is testing a combination of two drugs, selumetinib and azacitidine, for people with high-risk chronic myeloid leukemia or myelofibrosis. Researchers want to find the safest and most effective dose of selumetinib when given with standard azacitidine. You would receive azacitidine as an injection for 7 days, followed by selumetinib pills for 14 days, in repeating cycles. The main goal is to track any side effects you might experience over up to 24 months. You may be eligible if you are 18 or older and have a confirmed diagnosis of certain high-risk blood cancers.", "design": "This is a Phase 1, open-label study involving about 18 participants. It is designed to find the maximum tolerated dose of selumetinib when combined with azacitidine.", "commitments": "You would receive azacitidine injections for 7 days and selumetinib pills for 14 days, with treatment continuing as long as you benefit. Treatment will begin within 28 days of screening.", "compensation": "Not stated in the trial record.", "follow_up": "You will be followed for 12 weeks after your last dose of study drug, or until any side effects have stabilized, or until death.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

Recruiting

PHASE1Ages 18+InterventionalTreatment

University of Chicago

~18 participants

Updated 2025-12-29 on ClinicalTrials.gov

What's tested:AzacitidineSelumetinib

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of patients with adverse events

Measured over Up to 24 months.

Conditions

Chronic Myeloid Leukemia

Myelofibroses

Where it's being run

1 sites across 1 states

Illinois1

Study leadership

Olatoyosi Odenike, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Cancer Clinical Trials Office

[email protected]

1-855-702-8222

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age greater than or equal to 18 years of age

Histologic confirmation of one of the following:

No history of prior exposure to a MEK inhibitor

ECOG performance status of ≤ 2

Adequate renal function, defined as serum creatinine ≤ 1.5 x ULN or creatinine clearance \>30 mL/min based on the Cockroft-Gault equation: (140 - Age) x (weight in kg) x (0.85 if female) / 72 x serum creatinine

Adequate liver function, defined as conjugated bilirubin ≤ 2 x ULN as well as aspartate transaminase (AST) and alanine aminotransaminase (ALT) ≤ 3 x ULN

Patients must be at least 2 weeks from major surgery, radiation therapy, participation in other investigational trials and must have recovered from clinically significant toxicities of these prior treatments

Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment

Female and male patients must use an effective contraceptive method during the study and for at least 6 months thereafter

Ability to understand and willingness to sign a written informed consent document

Exclusion

Receipt of any anti-cancer therapy within 14 days prior to study entry, with the exception of hydroxyurea. If clinically indicated in order to keep WBC \<30,000/uL, hydroxyurea may be continued through the first cycle.

Concurrent active malignancy, with the exception of early stage basal cell or squamous cell skin cancer

Active cardiac conditions, including any of the following:

Ophthalmologic conditions, including any of the following:

Any uncontrolled concurrent illness that, in the judgment of the investigators or treating physician, may put the patient at undo risk including but not limited to active infection, symptomatic cardiac or pulmonary disease, ventricular arrhythmia, or psychiatric illness.

Pregnant or lactating patients

What this trial measures

Number of patients with adverse eventsUp to 24 months.
To determine the maximum tolerated dose (MTD) of selumetinib when combined with azacitidine and measure any toxicities that may arise.

Trialytics