Is NCT03326310 recruiting in Chicago, IL?

Yes, NCT03326310 is currently recruiting participants at its Chicago, IL location. This chronic myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the chronic myeloid leukemia clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Chronic Myeloid Leukemia Clinical Trial in Chicago, IL

About This Chronic Myeloid Leukemia Study in Chicago

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.

Sponsor: University of Chicago

Who Can Participate

Inclusion Criteria

All of the following criteria must be met:

Age greater than or equal to 18 years of age

Histologic confirmation of one of the following: a. MDS fulfilling all the criteria below: i. International Prognostic Scoring System (IPSS) intermediate-2 or high risk MDS; or Revised International Prognostic Scoring System (IPSS-R) intermediate, high, or very high risk MDS ii. - relapsed/refractory disease iii. Requiring therapy based on the presence of one or more cytopenias (Hb \<10 g/dL and/or red cell transfusion dependence, platelets- \<50,000/μL, or ANC \<1,000/ μL) or excess blasts (≥5% in the peripheral blood or bone marrow). b. MDS/MPN as defined by the WHO criteria, including CMML, atypical CML, and MDS/MPN-Unclassifiable fulfilling the criteria listed below i. relapsed/refractory disease ii. Requiring therapy based on the presence of one or more cytopenias (Hb \<10 g/dL and/or red cell transfusion dependence, platelets \<50,000/μL, or ANC \<1,000/ μL), excess blasts (≥5% in the peripheral blood or bone marrow), or palpable splenomegaly iii. or previously untreated subsets (e.g atypical CML, MDS/MPN unclassifiable) requiring therapy as defined above and in whom no approved therapies exist. c. Myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis fulfilling the criteria listed below: i. Intermediate-2 or high risk disease according to the Dynamic International Prognostic Scoring System (DIPSS) classification ii. refractory or intolerant to JAK inhibitor therapy, or deemed - ineligible for ruxolitinib therapy due to pre- existing cytopenias (thrombocytopenia \<50,000/uL, anemia hemoglobin \<9g/dL or red cell transfusion dependence).Requiring further therapy based on the presence of one or more cytopenias (Hb \<10 g/dL and/or red cell transfusion dependence, platelets \<50,000/μL, or ANC \<1,000/μL), excess blasts (≥5% in the peripheral blood or bone marrow), or palpable splenomegaly

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 Criteria

Patients are excluded if any one of the following is present:

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:

Uncontrolled hypertension (BP \>150/95 mmHg despite medical therapy)

Acute coronary syndrome within 6 months prior to starting treatment

Uncontrolled angina despite medical therapy

Symptomatic heart failure (NYHA class II-IV despite medical therapy)

Baseline LV EF \<50% measured by either echocardiography or MUGA scan

Severe valvular heart disease

Atrial fibrillation with ventricular rate \>100 bpm on EKG at rest.

Ophthalmologic conditions, including any of the following:

Current or past history of central serous retinopathy

Current or past history of retinal vein occlusion

Intraocular pressure (IOP) \>21 mmHg or uncontrolled glaucoma

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chicago?

Yes, this clinical trial (NCT03326310) has an active research site in Chicago, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Myeloid Leukemia Treatment Options in Chicago, IL

If you're searching for chronic myeloid leukemia treatment options in Chicago, IL, this clinical trial (NCT03326310) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chicago research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Chronic Myeloid Leukemia Clinical Trial in Chicago, IL

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