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NCT06928662 · ClinicalTrials.gov registry record · Phase 1

Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse

A Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by Fred Hutchinson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
36
Enrollment target
1
Study location

NCT06928662 is a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 36 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06928662, a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

This phase I/II trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (relapse). Cancers eligible for this trial are acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The FLAG-Ida regimen consists of the following drugs: fludarabine, cytarabine, filgrastim, and idarubicin. These are chemotherapy drugs that 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. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils, a type of white blood cell. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is radiation therapy to the entire body. Giving chemotherapy and TBI before a donor peripheral blood stem cell (PBSC) transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. Giving decitabine in combination with FLAG-Ida and TBI before donor PBSC transplant may work better than FLAG-Ida and TBI alone in treating adult patients with myeloid malignancies at high risk of relapse.

Interventions

  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • DRUG Decitabine
  • PROCEDURE Chest Radiography
  • DRUG Cytarabine

Study Locations (1)

Washington

  • Fred Hutch/University of Washington Cancer Consortium - Seattle

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2025-09-23
Est. Completion 2028-11-29
Phase Phase 1

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT06928662

The ClinicalTrials.gov registry entry for NCT06928662 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 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 (69% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Bone Marrow Aspiration is the first listed.

NCT06928662 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT06928662 about?

NCT06928662 is a clinical study titled "Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse". This phase I/II trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming ce...

What is the current status of trial NCT06928662?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-09-23. Estimated completion is 2028-11-29.

What conditions does trial NCT06928662 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Mixed Phenotype Acute Leukemia, Recurrent Myelodysplastic Syndrome.

What interventions are being tested in trial NCT06928662?

The interventions under investigation include: Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Decitabine (DRUG), Chest Radiography (PROCEDURE), Cytarabine (DRUG).

Who is sponsoring clinical trial NCT06928662?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06928662 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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