Aurora, CONCT06429449Now EnrollingIRB Ready

Leukemia Clinical Trial in Aurora, CO

Access cutting-edge leukemia treatment through this clinical trial at a research site in Aurora. Study-provided care at no cost to qualified participants.

Sponsored by University of Colorado, Denver

Quick Self-Assessment

See if you qualify for this Aurora location

Preparing your pre-screening questions…

Expert Care in Aurora

Access leukemia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related leukemia treatment provided free

Apply for This Aurora Location

Check if you qualify for this leukemia clinical trial in Aurora, CO

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Aurora

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Aurora site if eligible
  4. 4Begin participation

About This Leukemia Study in Aurora

This is an open label, phase 1 study for AML subjects with relapsed or refractory disease or subjects in morphologic remission with MRD+ after first line therapy with venetoclax+HMA. A preliminary dose-finding cohort will be followed by 3 expansion cohorts.

Sponsor: University of Colorado, Denver

Who Can Participate

Inclusion Criteria

Subject must have confirmation of non-APL AML by WHO criteria and have been treated with first-line venetoclax/HMA (azacitidine or decitabine).
Subject must have relapsed disease per IWG criteria or disease refractory to first line venetoclax/HMA defined by less than a PR response after ≥ 1 complete cycle of venetoclax/HMA.
Subject must have either measurable residual disease (MRD+), as measured by FDA-approved flow cytometric test performed by Hematologics (cohort 3 and 4) or relapsed/refractory disease (cohort 1 and 2).
Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 2.
Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min, calculated using the formula CKD-EPI Creatinine Equation
Subject must have adequate heart function as measured by left ventricular ejection fraction (LVEF) \>50%, assessed by multigated acquisition (MUGA) or echocardiogram (ECHO) within 1 month prior to study day 1
Subject must have adequate liver function as demonstrated by:
aspartate aminotransferase (AST) ≤ 3.0 × ULN\
alanine aminotransferase (ALT) ≤ 3.0 × ULN\
bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome\
Unless considered due to leukemic organ involvement
Non-sterile male subjects must use contraceptive methods with partner(s) at least prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. No contraception is required if male subjects are surgically sterile (vasectomy with medical assessment confirming surgical success) or if the male subject has a female partner who is postmenopausal or permanently sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Female subjects must be either:
Postmenopausal; defined as Age \> 60 years with no menses for 12 or more months without an alternative medical cause; OR
Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); OR
If subject is of childbearing potential, use of contraception is required while on study treatment and for 6 months after the last dose.
Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed procedures.

Exclusion Criteria

Subject has known active CNS involvement from AML.
Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure \> class 2, unstable angina, or myocardial infarction.
Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g. sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment.
Subject has a history of other malignancies prior to study entry, with the exception of:
Adequately treated in situ carcinoma of the breast or cervix uteri
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
Prostate cancer not requiring therapy beyond hormonal therapy
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
Subject has a white blood cell count \> 25 × 109/L. Note: hydroxyurea or apheresis are permitted to meet this criterion (cohort 3 only).
Pregnant or breast-feeding females.
Known or suspected hypersensitivity to azacitidine or mannitol.
Any prior exposure to an anthracycline or anthracenedione

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 Aurora?

Yes, this clinical trial (NCT06429449) has an active research site in Aurora, CO 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.

Leukemia Treatment Options in Aurora, CO

If you're searching for leukemia treatment options in Aurora, CO, this clinical trial (NCT06429449) 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 Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced 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 leukemia clinical trials near you to find additional studies recruiting in your area.

More Leukemia Trials in Aurora, CO

See all leukemia clinical trials recruiting in Aurora — not just this study.

Browse Leukemia Trials in Aurora →

Browse More Trials by Condition

Leukemia TrialsB-Cell Acute Lymphoblastic Leukemia TrialsChronic Lymphocytic Leukemia TrialsAcute Myeloid Leukemia TrialsMyelodysplastic Syndromes TrialsHeart Attack TrialsPediatric Cancer TrialsMyocardial Infarction TrialsAll Conditions →

Ready to Join in Aurora?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Aurora, CO