Is NCT06707493 recruiting in Kansas City, KS?

Yes, NCT06707493 is currently recruiting participants at its Kansas City, KS location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Kansas City?

To join this clinical trial in Kansas City, 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 Kansas City 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.

Acute Myeloid Leukemia Clinical Trial in Kansas City, KS

Who Can Participate

Inclusion Criteria

Pathologically confirmed diagnosis of IDH1(R132)-mutant acute myeloid leukemia (AML). IDH1 mutations could have been detected by any mutational technique at any prior point including at diagnosis or remission.

Between the ages of 18 and 75 years

Will undergo allogeneic hematopoietic stem cell transplantation (HSCT) for their malignancy. Conditioning may be either conventional myeloablative (MAC) or reduced intensity conditioning (RIC). There will be no restrictions on type of graft source.

ECOG performance status ≤ 2

Participants must have normal organ and marrow function as defined below:

Absolute neutrophil count ≥ 1000/µL without growth factor support (e.g. GCSF) in the previous 7 days.

Platelet count ≥ 50,000/µL without transfusional support in the previous 7 days.

AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 3x institutional upper limit of normal (ULN)

Direct bilirubin \< 2.0 mg/dL

Calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)

LVEF must be equal to or greater than 40%, as measured by MUGA scan or echocardiogram

Female patients of childbearing potential must have a negative pregnancy test

The effects of ivosidenib on the developing human fetus are unknown. For this reason female participants of child-bearing potential and male participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 90 days after the last dose of treatment

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

Exclusion Criteria

Prior allogeneic hematopoietic stem cell transplants.

Morphologically relapsed or refractory disease, as assessed by bone marrow aspirate and biopsy performed within 42 days prior to study entry

History of other malignancy(ies) unless

the participant has been disease-free for at least 5 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or

the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin

Known diagnosis of active hepatitis B or hepatitis C

Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \< 40%, as measured by MUGA scan or echocardiogram)

Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome

QTc interval (i.e., Friderica's correction \[QTcF\]) ≥ 450 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening

Uncontrolled intercurrent illness that would limit compliance with study requirements. Post-transplantation Pre-Treatment Criteria Treatment may begin at any time between day 45 and day 90 following stem cell transplantation. However, at time of treatment start, it must be ensured that:

The patient has continued willingness and interest in participating in the study.

There is no systemic infection requiring IV antibiotic therapy within 7 days preceding the first dose of study drug, or other severe infection

Chimerism studies reveal that ≥ 70% of blood or bone marrow cells, or of the CD33 expressing fraction, are of donor origin,

There is no acute graft versus host disease (GVHD), requiring an equivalent dose of ≥ 0.5mg/kg/day of prednisone within one week of starting ivosidenib / placebo, or have escalation of systemic immunosuppression in terms of increase of corticosteroids or addition of new agent/modality within two weeks of starting ivosidenib / placebo.

For prophylaxis for GVHD, agents that are permitted for administration on study:

Cyclosporine

Cyclophosphamide

Mycophenolate Mofetil

Methotrexate

Ruxolitinib

Vedolizumab

As standards of care may change, any other prophylactic agents used should be discussed with the PI.

Investigational agents, defined as not approved for any indication, are forbidden unless the participant comes off study.

Agents used to treat GVHD that are permitted for administration on study:

Any agent used in prophylaxis may be continued (see list above)

Ruxolitinib

Belumosidil

Fecal microbiota transplantation

Alpha1-Antitrypsin

Extracorporal photopheresis (ECP)

As standards of care may change, any other treatment agents used should be discussed with the PI.

Investigational agents, defined as not approved for any indication, are forbidden unless the participant comes off study.

There is no evidence of relapsed/recurrent/residual disease.

Prior to the start of ivosidenib / placebo administration, the participant must have adequate hematological function, defined as:

ANC ≥ 1000/µL

Platelets ≥ 50,000/µL and adequate organ function defined as

Direct bilirubin level \< 2.0 mg/dL

AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 3x institutional upper limit of normal (ULN)

No presence of congestive heart failure, defined by New York Heart Association (NHYA) criteria as class 3 or 4

Calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)

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 Kansas City?

Yes, this clinical trial (NCT06707493) has an active research site in Kansas City, KS 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 Treatment Options in Kansas City, KS

If you're searching for acute myeloid leukemia treatment options in Kansas City, KS, this clinical trial (NCT06707493) 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 Kansas City research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced acute 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 acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Kansas City, KS

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