Aurora, CONCT07007312Now EnrollingIRB Ready

Acute Myeloid Leukemia (AML) Clinical Trial in Aurora, CO

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

Sponsored by Kura Oncology, Inc.

Quick Self-Assessment

See if you qualify for this Aurora location

Preparing your pre-screening questions…

Expert Care in Aurora

Access acute myeloid leukemia (aml) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related acute myeloid leukemia (aml) treatment provided free

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Check if you qualify for this acute myeloid leukemia (aml) clinical trial in Aurora, CO

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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 Acute Myeloid Leukemia (AML) Study in Aurora

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells. This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance. The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".

Sponsor: Kura Oncology, Inc.

Who Can Participate

Inclusion Criteria

The following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted:
Age ≥18 years at time of signing the informed consent form.
Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Adequate liver and kidney function according to protocol requirements.
A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male with a female partner of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention.
NONINTENSIVE THERAPY STUDY ONLY (VEN+AZA):
Documented NPM1-m.
Patients considered ineligible for Intensive Therapy defined by the following:
i. Age ≥75, OR
ii. Age \<75 with an ECOG performance status of 2 or cardiac, renal, or hepatic impairment per protocol criteria.
INTENSIVE THERAPY STUDY ONLY (7+3):
Documented NPM1-m or KMT2A-r (KMT2A-r patients with a partial tandem duplication are not eligible).
Documented FLT3 wild-type or ITD ratio \<0.05 OR ineligible to receive FLT3-targeted therapy (medically ineligible or mutation in which FLT3 inhibition is not SOC). Lack of access to an FLT3 inhibitor is not considered "ineligible" for FLT3-targeted therapy.
Ejection fraction of ≥50%.
Fit for Intensive Therapy per Investigator opinion. Key

Exclusion Criteria

Prior therapy for AML (except hydroxyurea or leukapheresis for WBC control).
Diagnosis of acute promyelocytic leukemia (APL), blast phase chronic myeloid leukemia, or isolated myeloid sarcoma.
Known history of BCR-ABL mutation.
History of other active concurrent malignancies prior to study entry except:
Basal cell skin cancer or localized squamous cell cancer of the skin
Previous malignancy confined and locally resected (or treated with other modalities) with curative intent
Prostate or breast cancer receiving adjuvant hormonal therapy.
Active central nervous system (CNS) involvement by AML.
Clinical signs/symptoms of leukostasis or white blood cells (WBC) \>25×10\^9/L prior to start of ziftomenib/placebo. Note: Hydroxyurea and/or leukapheresis are permitted to meet this criterion.
Known uncontrolled HIV infection or known active hepatitis B virus, hepatitis C virus infection, or other uncontrolled infection.
Uncontrolled intercurrent illness including but not limited to, cardiac illness as defined in the protocol.
Women who are pregnant or lactating.

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 (NCT07007312) 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.

Acute Myeloid Leukemia (AML) Treatment Options in Aurora, CO

If you're searching for acute myeloid leukemia (aml) treatment options in Aurora, CO, this clinical trial (NCT07007312) 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 acute myeloid leukemia (aml) 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 acute myeloid leukemia (aml) clinical trials near you to find additional studies recruiting in your area.

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