Secondary Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase II Study of the Impact of Clinicogenetic Risk-Stratified Management on Outcomes of Acute Myeloid Leukemia in Older Patients
Verified date | September 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial of the impact of clinicogenetic risk-stratified management on outcomes of acute myeloid leukemia in older patients is to determine the rate of complete remission and mortality at 90 days in the entire cohort of older patients (≥60 years) with newly diagnosed acute myeloid leukemia, who receive clinicogenetic risk-stratified therapy allocation. Subjects will receive standard of care intensive or low-intensity induction based on cytogenetic and geriatric assessment-based risk stratification. Subjects 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.
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | October 7, 2024 |
Est. primary completion date | October 7, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion criteria: 1. A new diagnosis of de novo, secondary or treatment-related AML, other AML equivalent such as myeloid sarcoma, myelodysplastic syndrome in transformation to AML, or high-grade treatment-related myeloid neoplasm 2. Patients aged =60 years 3. Karnofsky Performance Status =60% 4. Subjects must be able and willingly give signed informed consent Exclusion criteria: 1. Acute promyelocytic leukemia (APL). Patients with brief exposure to all-trans retinoic acid (ATRA), arsenic trioxide (ATO) or similar product for suspected APL, who later turn out not to have APL, are eligible for the study. 2. Relapsed or refractory AML, who require salvage therapy 3. Prior exposure to decitabine or azacitidine will be an exclusion criterion for the use of decitabine or azacitidine alone. 4. Patients, who require urgent initiation of chemotherapy (other than debulking agent such as hydroxyurea or cyclophosphamide) due to leukemia-related emergencies such as leukostasis, or disseminated intravascular coagulopathy. Patients will not be excluded solely based on prior use of debulking agent. Prior or current use of leukapheresis will be allowed. 5. Uncontrolled serious infection at the time of enrollment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, patients do not have signs of infection progression. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection 6. Uncontrolled clinically significant arrhythmia, myocardial ischemia or congestive heart failure within the past 2 weeks, that is considered by the treating physician as a contraindication for initiation of chemotherapy. 7. Ejection fraction <45% will be an exclusion criteria for intensive chemotherapy. Such patients may receive low intensity therapy. 8. Clinically significant kidney (e.g. GFR =45ml/minute or Creatinine of =2 mg/dl) or liver dysfunction (e.g. AST/ALT and/or bilirubin =2 times ULN) at the time of enrollment that may prevent from safely using chemotherapy. Such patients may be allowed to receive low-intensity chemotherapy. Patients with elevated bilirubin secondary to Gilbert syndrome will not be excluded. 9. Any other condition that may not allow safe use of chemotherapy based on the clinical judgment of the treating oncologist. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of complete remission and mortality in the entire cohort of older patients | All analyses will be performed based on intent-to-treat principle. The method of inversion will be used to generate an interval estimate for the proportion of 90-day mortality. | At 90 days | |
Secondary | Rate of complete remission and mortality in subsets of older patients who receive intensive and low-intensity chemotherapy | All analyses will be performed based on intent-to-treat principle. The method of inversion will be used to generate an interval estimate for the proportion of 90-day mortality. | At 90 days | |
Secondary | Baseline functional status measure by geriatric assessment | Will assess the impact of baseline functional status on the rate of complete remission and mortality. | At 90 days | |
Secondary | Baseline functional status | Will evaluate the influence of baseline functional status on the quality of life and neurocognitive status. The association between categories of functional status and quality of life will be explored using analysis of variance (ANOVA); if assumptions of ANOVA fail, Kruskal Wallis will be used. The association between functional status (fit or vulnerable) and neurocognitive status (< 25 or 26 or higher) will be explored using a chi-square test. A generalized linear mixed model will be utilized to evaluate changes in quality of life over time. The proportion (and associated 95% confidence interval) of patients with definitely or probably modifiable impairments will be presented. | Up to 90 days | |
Secondary | Functional status | The association between functional status and grade 3/4 toxicities will be explored using ANOVA; if assumptions of ANOVA fail, Kruskal Wallis will be used. | Up to 90 days | |
Secondary | Symptom burden | Will determine the symptom burden at diagnosis and 10, 30 and 90 days following initiation of chemotherapy. | Up to 90 days following initiation of chemotherapy | |
Secondary | Mortality | Mortality at 90 days will be calculated as the time from date of diagnosis to date of death due to any cause by 90 days from diagnosis. | From the time of diagnosis to death, assessed up to 90 days | |
Secondary | Quality of life as measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0 | Composite scores, as determined by EORTC QLQ-C30 version 3.0, will be utilized to determine quality of life status. A generalized linear mixed model will be utilized to evaluate changes in quality of life over time. | Up to 4 years | |
Secondary | Neurocognitive status as measured by the Montreal Cognitive Assessment (MoCA) | Composite scores, as determined by MOCA test, will be utilized to determine neurocognitive status. | Up to 4 years |
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