Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-02 @ 10:36 AM
Study NCT ID:
NCT07094750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomization for the Identification of Best Treatment Intensity for Less Fit Adults With Acute Myeloid Leukemia and Myeloid Neoplasms
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Impact of Treatment Intensity on Survival, Quality of Life, and Resource Utilization in Medically Less Fit Adults With Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms: A Randomized Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial studies whether less fit adults with acute myeloid leukemia (AML) or myeloid neoplasms are willing to let a computer program decide (randomization) whether they receive lower- or higher-intensity chemotherapy. Historically, treatment decision-making for patients with AML or myeloid neoplasms has divided patients into two categories, with patients considered fit receiving intensive "curative" chemotherapy, and patients considered unfit, such as older patients with a higher risk of early death from therapy, receiving non-intensive "palliative" therapy or no therapy. With the introduction of new treatment agents, it has become difficult to determine the difference between intensive and non-intensive therapy, especially for patients considered unfit for whom treatment-related side effects remain a concern. Treatment intensity is best identified through randomized trials but often patients are unwilling to undergo randomization due to preset beliefs. However, with improved supportive care and the awareness that new treatment agents may have similar risks as intensive therapy, it may be possible that more patients are willing to be randomized. This may help identify the best treatment intensity for less fit adults with AML or myeloid neoplasms, which may improve outcomes.
Detailed Description:
OUTLINE:
This pilot umbrella trial will explore the feasibility of randomizing patients to higher or lower intensity treatment regimens.
The exact treatment regimens given will be at the discretion of the treating physician and will be provided either as standard of care or following enrollment on a subsequent treatment trial.
Patients and physicians indicate willingness to randomize, those willing are randomized to 1 of 2 arms, those unwilling choose arm III or IV.
ARM I: Patients receive standard of care (SOC) or investigational higher-intensity therapy on a subsequent treatment trial that is at least as intense as seven days of cytarabine in combination with three days of anthracycline (7+3 regimen) at the discretion of the treating physician on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive SOC or investigational lower-intensity therapy on a subsequent treatment trial that is less intense than five days of cytarabine in combination with two days of anthracycline (5+2 regimen) at the discretion of the treating physician on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive SOC or investigational higher-intensity therapy on a subsequent treatment trial that is at least as intense as 7+3 regimen according to physician/patient preference on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM IV: Patients receive SOC or investigational lower-intensity therapy on a subsequent treatment trial that is less intense than 5+2 regimen according to physician/patient preference on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
Additionally, all patients undergo blood sample collection and bone marrow assessments on study.
After completion of study treatment, patients are followed up periodically for up to 24 months.
This pilot umbrella trial will explore the feasibility of randomizing patients to higher or lower intensity treatment regimens.
The exact treatment regimens given will be at the discretion of the treating physician and will be provided either as standard of care or following enrollment on a subsequent treatment trial.
Patients and physicians indicate willingness to randomize, those willing are randomized to 1 of 2 arms, those unwilling choose arm III or IV.
ARM I: Patients receive standard of care (SOC) or investigational higher-intensity therapy on a subsequent treatment trial that is at least as intense as seven days of cytarabine in combination with three days of anthracycline (7+3 regimen) at the discretion of the treating physician on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive SOC or investigational lower-intensity therapy on a subsequent treatment trial that is less intense than five days of cytarabine in combination with two days of anthracycline (5+2 regimen) at the discretion of the treating physician on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM III: Patients receive SOC or investigational higher-intensity therapy on a subsequent treatment trial that is at least as intense as 7+3 regimen according to physician/patient preference on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM IV: Patients receive SOC or investigational lower-intensity therapy on a subsequent treatment trial that is less intense than 5+2 regimen according to physician/patient preference on study. Treatment continues in the absence of disease progression or unacceptable toxicity.
Additionally, all patients undergo blood sample collection and bone marrow assessments on study.
After completion of study treatment, patients are followed up periodically for up to 24 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-04530 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |