Trial · 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
NCT07046078, Phase 2, Recruiting, Fred Hutchinson Cancer Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT07046078. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07046078
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT07046078
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
- Acute Leukemia of Ambiguous Lineage, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome
- Interventions
Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Cytarabine, Echocardiography Test, Fludarabine, Idarubicin, Multigated Acquisition Scan, Peripheral Blood Stem Cell, Questionnaire Administration, Recombinant Granulocyte Colony-Stimulating Factor, Total-Body Irradiation
- First posted
- 2025-07-01
- Last updated
- 2026-07-20
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants starting study treatment with FLAG-Ida within 42 days of the date of informed consent | Up 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. |
| Secondary | Number of patients transplanted | Up to 2 years | Will evaluate the number of patients transplanted. |
| Secondary | Time from day of consent to day of allogeneic hematopoietic cell transplant (HCT) | From day of consent to day of allogeneic hematopoietic cell transplant (HCT) | Will evaluate time from day of consent to day of allogeneic HCT. |
| Secondary | Reasons for failure to undergo allogeneic transplantation (allo-HCT) | Up to 2 years following Screening enrollment | Identified reasons for failure to undergo allogeneic transplantation (e.g., lack of suitable donor, complications of disease) will be systematically categorized and quantitatively reported. |
| Secondary | Incidence of adverse events | From start of conditioning (Day -9) to study-defined neutrophil engraftment, or adversely, to graft failure | Will evaluate the number of participants with non-hematologic adverse events ≥ grade 3. Will use the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for toxicity and adverse event reporting. |
| Secondary | Neutrophil count recovery | Day 0 to study-defined neutrophil engraftment, or adversely, to graft failure. | Will evaluate the time to neutrophil count recovery. The day of neutrophil recovery will be the 1st day of 2 consecutive days of absolute neutrophil count at or above 500/µL. |
| Secondary | Platelet count recovery | Day 0 to study-defined platelet engraftment | Will evaluate the time to platelet count recovery. Platelet engraftment will be defined as the first of 7 days of a platelet count \> 20,000/µl without subsequent transfusions for 7 days. |
| Secondary | Incidence of severe adverse events | From start of conditioning (Day -9) to study-defined neutrophil engraftment, or adversely, to graft failure | Will evaluate the number of participants with any severe adverse event. Will use the NCI CTCAE version 5.0 for toxicity and adverse event reporting. |
| Secondary | Non-relapse mortality (NRM) | Up to day 100 after HCT | Will evaluate the number of participants experiencing NRM by day +100 after HCT. |
| Secondary | Rate of CD3 chimerism | At day 80 (+/- 7 days) | Will evaluate the rate of peripheral blood CD3 chimerism at day 80 (±7 days). Mixed or full donor chimerism will be evidence of donor engraftment. Full chimerism: \> 95% donor CD3+ T cells. Mixed chimerism: the detection of peripheral blood donor T cells (CD3+) and granulocytes (CD33+) as a proportion of the total peripheral blood T cell and granulocyte population, respectively. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07046078
GET https://conductscience.org/api/trials/v1/NCT07046078/registered