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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

StatusRecruiting
PhasePhase 2
Started2025-09-26
View on ClinicalTrials.gov ↗

Amendment history

2026-07-17
minor
Study Status v7
Re-verified, no change to tracked fields
2026-01-28
minor
Study Status, Study Description, Arms and Interventions, Eligibility v6
Eligibility criteria+293 characters
[...] c therapy (e.g., presenting with leukopenia or pancytopenia), defined as a clinical scenario in which delay of systemic leukemia-directed treatment would be unsafe. Supportive cytoreduction with hydroxyurea for transient disease control is allowed, and does not constitute immediate anti-neoplastic treatment PARTICIPANTS: Interest in pursuing allogeneic HCT PARTICIPAN [...] any other approved or investigational anti-leukemia agent(s) at the time of initiation of study treatment PARTICIPANTS: Concomitant illness associated with a likely [...]
Study description+6 characters
[...] undergo TBI QD on days -1 and 0 or twice daily (BID) on day -1 or 0. Patients then undergo allogeneic HCT with unmodified per [...]
2025-12-16
minor
Study Status v5
Re-verified, no change to tracked fields
2025-09-26
minor
Study Status v4
Start dateestimated 2025-10-01→confirmed 2025-09-26
2025-09-08
minor
Study Status v3
Start date2025-09-01→2025-10-01
Show 2 earlier versions
2025-07-30
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2025-07→2025-09-01
Study sitesdetails revised at 1 of 1 site
2025-06-30
minor
Study Status, Eligibility v1
Start date2025-07-01→2025-07
Eligibility criteria+158 characters
[...] potential (WOCBP) must have a negative serum pregnancy test during screening (within 722 hoursweeks of treatment initiation, per Fred Hutch Cancer Center [FHCC] standard of care [SOC]), where WOCBP are defined as all female participants between 18-55 years of age, unless postmenopausal or with hysterectomy PARTICIPANTS: HIV-infected patients on effective anti-retro [...] safety or efficacy assessment of the investigational regimen, as determined by the investigator, are eligible for this trial DONORS: Patients must have an H [...]
2025-06-23
minor
Original filing
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.
Trial Details
NCT Number NCT07046078
Lead Sponsor Fred Hutchinson Cancer Center
Conditions Acute Leukemia of Ambiguous Lineage, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome
Enrollment 20 participants
Start Date 2025-09-26
Primary Completion 2027-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-20