FLAG-Ida Chemotherapy and Transplant for High-Risk Myeloid Cancers in Older Adults
This study is testing a treatment plan for adults aged 60 and older with newly diagnosed, high-risk acute myeloid leukemia (AML) or other serious myeloid cancers. The treatment involves combination chemotherapy called FLAG-Ida (fludarabine, high-dose cytarabine, G-CSF, and idarubicin), followed immediately by reduced-intensity total body radiation therapy (TBI) and a donor hematopoietic cell transplant (HCT). Researchers want to see how safe and effective this approach is, especially since current treatments for older adults with these conditions often don't work well. The study aims to enroll 20 participants and will measure how many start the FLAG-Ida treatment within 42 days of joining.
- Study design
- This is an interventional study, meaning you will receive a specific treatment. It plans to enroll 20 participants.
- What's involved
- You would receive chemotherapy (FLAG-Ida), total body radiation, and a donor transplant. You will also have blood and bone marrow samples collected, and heart scans (MUGA or ECHO) at various times.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you will have follow-up visits at 28, 56, and 80 days, at 3 and 6 months, and at 1 and 2 years.
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NCT07046078
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
Recruiting
PHASE2Ages 18+InterventionalTreatmentFred Hutchinson Cancer CenterInvestigator-initiated
~20 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Allogeneic Hematopoietic Stem Cell TransplantationBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyCytarabineEchocardiography Test
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants starting study treatment with FLAG-Ida within 42 days of the date of informed consent
Measured over Up to 42 days after informed consent
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Filippo Milano, MD, PhD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
PARTICIPANTS: Age ≥ 60 years. Adults age \< 60 years are eligible if they are felt to be unsuitable candidates for myeloablative conditioning as per physician assessment
PARTICIPANTS: Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of potential study participants
PARTICIPANTS: Newly diagnosed, untreated high-risk myeloid or mixed myeloid/lymphoid neoplasm:
Adverse-risk AML (using 2022 International Consensus Classification for disease categorization and 2022 European LeukemiaNet \[ELN\] criteria for molecular/cytogenetic risk assignment)
Acute leukemia of ambiguous lineage (using 2022 International Consensus Classification for disease categorization)
High-risk myelodysplastic neoplasm (MDS) (Molecular International Prognostic System \[IPSS-M\] moderate high, high, or very high, OR ≥ 10% blasts in blood or marrow)
High-risk chronic myelomonocytic leukemia (CMML) (clinical/molecular CMML-specific prognostic scoring system \[CPSS-Mol\] intermediate-2 or high, OR ≥ 10% blasts in blood or marrow)
Prior treatment of MDS or CMML with lower-intensity therapy (e.g., growth factors, erythropoiesis-stimulating agents, and lenalidomide) is permissible, but patients may not have received prior hypomethylating agents
PARTICIPANTS: Disease not requiring immediate anti-neoplastic 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
PARTICIPANTS: Available caregiver
PARTICIPANTS: Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) performance status 0-2
PARTICIPANTS: Bilirubin ≤ 2.5 x institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by myeloid neoplasm, Gilbert's syndrome, or hemolysis
PARTICIPANTS: Serum creatinine ≤ 1.5 mg/dL
PARTICIPANTS: Prior autologous HCT is permissible if \> 6 months after planned HCT on this study
PARTICIPANTS: Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception 7 days before initiation of study treatment and for at least 12 months after HCT. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during screening (within 2 weeks 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-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
PARTICIPANTS: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load
PARTICIPANTS: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen, as determined by the investigator, are eligible for this trial
DONORS: Patients must have an HLA-matched related donor, an HLA-matched or mismatched unrelated donor, or an HLA- haploidentical donor who meets standard Fred Hutchinson Cancer Center (FHCC) and/or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) donation as follows:
HLA-matched related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing
HLA-matched unrelated donor:
10/10 matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing
Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
HLA-mismatched unrelated donor:
HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ
Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing
HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and/or DQB1 antigen/allele mismatch
Donor/recipient HLA mismatching at loci for which the patient is homozygous is not allowed (isolated rejection vector)
HLA-haploidentical donor:
Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5/10 HLA loci
Donor age ≥ 12 years
Donor weight ≥ 40 kg
Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival
Donor must meet the selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines
In case of more than one available haploidentical donor, preference should be given to younger age
Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Use of donors requiring desensitization treatment of the patient are not permissible
Exclusion
PARTICIPANTS: Active central nervous system (CNS) disease
PARTICIPANTS: Decompensated congestive heart failure and/or uncontrolled arrhythmia and/or significant medical history of cardiac disease precluding allogeneic HCT
PARTICIPANTS: Significant medical history of pulmonary disease and/or symptoms suggestive of pulmonary disease precluding allogeneic HCT
PARTICIPANTS: Treatment with any other approved or investigational anti-leukemia agent(s) at the time of initiation of study treatment
PARTICIPANTS: Concomitant illness associated with a likely survival of \< 1 year
PARTICIPANTS: Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with antimicrobials and/or controlled or stable. Patients with fever thought to be secondary to myeloid malignancy are eligible
PARTICIPANTS: Known hypersensitivity or contraindication to receiving any of the study drugs used in this trial, including post-transplant cyclophosphamide (PTCy)
PARTICIPANTS: Pregnancy or lactation
PARTICIPANTS: Psychiatric illness/social situations that would limit compliance with study requirements
What this trial measures
- Proportion of participants starting study treatment with FLAG-Ida within 42 days of the date of informed consentUp to 42 days after informed consent
Will evaluate the proportion of participants starting study treatment with FLAG-Ida within 42 days of the date of informed consent.