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NCT03226418 · ClinicalTrials.gov registry record · Phase 2
Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia
A Phase 2 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT03226418 is a Phase 2 study that has completed, run by University of Nebraska. The registered enrollment target is 75 participants.
The verdict
NCT03226418, a Phase 2 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
Acute myeloid leukemia (AML) is among the most common hematologic malignancies in adults and accounts for approximately 10,000 deaths in the United States every year. AML is commonly diagnosed in sixth or seventh decades of life. The management of AML is complex in older patients because of associated comorbidities, intolerance to high-dose chemotherapy and high-risk tumor biology. In real world practice, over one-third of patients aged 60 years and older do not receive initial chemotherapy for AML, consequently, only 10-20% of patients are alive at 3-5 years. Longer-term survival has not improved significantly in last few decades. Poor survival of older patients with AML may be improved with refined risk-stratification and therapy selection strategies, integration of principles of geriatric medicine, and use of effective but low intensity and novel therapies. This study will examine the impact of clinicogenetic risk-stratified management on outcomes of acute myeloid leukemia in older participants (≥ 60 years) with newly diagnosed acute myeloid leukemia who receive clinicogenetic risk-stratified therapy allocation. Participants will receive standard of care intensive or low-intensity induction based on cytogenetic and geriatric assessment-based risk stratification. Participants will be evaluated for disease status, survival, quality of life and neurocognitive status for 90 days and then followed for a total of 2 years for survival data.
Interventions
- DRUG Decitabine
- OTHER Laboratory Biomarker Analysis
- DRUG Cytarabine
- DRUG Idarubicin
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2017-07-07 |
| Est. Completion | 2024-10-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03226418
The ClinicalTrials.gov registry entry for NCT03226418 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Decitabine is the first listed.
NCT03226418 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03226418 about?
NCT03226418 is a clinical study titled "Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia". Acute myeloid leukemia (AML) is among the most common hematologic malignancies in adults and accounts for approximately 10,000 deaths in the United States every year. AML is commonly diagnosed in sixth or seventh decades of life. The management of AML is complex in older patients because of associat...
What is the current status of trial NCT03226418?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2017-07-07. Estimated completion is 2024-10-01.
What interventions are being tested in trial NCT03226418?
The interventions under investigation include: Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Cytarabine (DRUG), Idarubicin (DRUG), Liposome-encapsulated Daunorubicin-Cytarabine (DRUG).
Who is sponsoring clinical trial NCT03226418?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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