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NCT07046078 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07046078 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 20 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07046078, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 bloo
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Cytarabine
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-09-26 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07046078
The ClinicalTrials.gov registry entry for NCT07046078 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07046078 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT07046078 about?
NCT07046078 is a clinical study titled "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". 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 irradia...
What is the current status of trial NCT07046078?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-09-26. Estimated completion is 2029-06-30.
What conditions does trial NCT07046078 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Acute Leukemia of Ambiguous Lineage.
What interventions are being tested in trial NCT07046078?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Cytarabine (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT07046078?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07046078 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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