RecruitingPhase 2NCT07046078

Combination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hematopoietic Cell Transplant for the Treatment of Adults Age 60 and Older With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia or Other High-Grade Myeloid Cancer

Pilot Study of FLAG-Ida Followed Immediately by Reduced-Intensity Allogeneic HCT for Adults Age 60 and Older With Newly Diagnosed Adverse-Risk AML or Other High-Grade Myeloid Neoplasm


Sponsor

Fred Hutchinson Cancer Center

Enrollment

20 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests the safety, side effects, and how well combination chemotherapy with fludarabine, high-dose cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin (FLAG-Ida) followed immediately by reduced-intensity total body radiation therapy, called total body irradiation (TBI), and donor hematopoietic cell transplant (HCT) works in treating adults age 60 and older with newly diagnosed adverse-risk acute myeloid leukemia (AML) or other high-grade myeloid cancer. Despite advances in supportive care and the approval of more than 10 new drugs since 2017, the outcomes of older adults with adverse-risk acute myeloid leukemia and other high-grade myeloid cancers remains poor. Most patients are expected to die from their cancer or the consequences of treatment-related side effects. Donor HCT is a very important part of any curative-cancer treatment for these patients. However, while accepted as standard care for decades, this treatment exposes patients to long periods of drug-induced low blood cell counts and the problems associated with low blood counts, like infections and bleeding, which are associated with significant risk of chronic side effects and death. This study will use a different approach to the upfront curative-cancer treatment of older adults with an adverse-risk AML or other high-grade myeloid cancer. This study will use intense chemotherapy followed a few days later by lower-dose TBI and donor HCT. Chemotherapy drugs, such as idarubicin, fludarabine, high-dose cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. G-CSF helps the bone marrow make more white blood cells in patients with low white blood cell count due to cancer treatment. This approach allows effective treatment of cancer cells and overall reduction of the period of low blood cells counts. This decreases the risk for problems associated with low blood counts, such as infection and chronic side effects. Decreasing these are important for older adults who undergo HCT. This treatment strategy may improve treatment outcomes by allowing more patients to successfully undergo donor HCT and reduce the risk of low blood cell counts and the problems associated with low blood counts. Giving chemotherapy followed immediately by reduced-intensity TBI and donor HCT may be safe, tolerable and/or effective in treating adults age 60 and older with newly diagnosed adverse-risk AML or other high-grade myeloid cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an intensive treatment approach for older adults with newly diagnosed high-risk blood cancers — including aggressive forms of AML (acute myeloid leukemia) and high-risk MDS (a pre-leukemia condition). The treatment combines intensive chemotherapy (FLAG-Ida) followed quickly by a stem cell transplant from a donor using lower-intensity conditioning radiation, aiming to cure or control the cancer while managing treatment-related risks in older patients. **You may be eligible if...** - You are 60 or older (or younger if deemed unsuitable for standard intense transplant conditioning) - You have a newly diagnosed high-risk blood cancer (adverse-risk AML, high-risk MDS, high-risk CMML, or acute leukemia of ambiguous lineage) - You want to pursue a donor stem cell transplant - You have a Karnofsky score of 70 or higher (able to care for yourself) - You have normal enough kidney and liver function **You may NOT be eligible if...** - You have already received hypomethylating agent therapy for your blood cancer - You have had a prior stem cell transplant less than 6 months ago - Your disease requires immediate emergency treatment - You do not have an available caregiver - You are pregnant or not willing to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HCT

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow biopsy and/or aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and/or aspiration

DRUGCytarabine

Given IV

PROCEDUREEchocardiography Test

Undergo ECHO

DRUGFludarabine

Given IV

DRUGIdarubicin

Given IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

BIOLOGICALPeripheral Blood Stem Cell

Given IV

OTHERQuestionnaire Administration

Ancillary studies

BIOLOGICALRecombinant Granulocyte Colony-Stimulating Factor

Given SC

RADIATIONTotal-Body Irradiation

Undergo TBI


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT07046078


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