This clinical trial studies how well simplified patient care strategy works in decreasing early death in patients with acute promyelocytic leukemia. Implementing simplified acute promyelocytic leukemia guidelines along with support from acute promyelocytic leukemia experts may decrease deaths and improve survival.
PRIMARY OBJECTIVES: I. To evaluate if the proposed patient care strategy, that includes use of simplified guidelines along with acute promyelocytic leukemia (APL) expert support, decreases the one-month induction mortality rate from 30% to under 15%. SECONDARY OBJECTIVES: I. To assess the overall survival 1 year after accrual is completed. II. To assess incidence and severity of differentiation syndrome. III. To correlate outcomes with time to initiation of all-trans retinoic acid (ATRA) from diagnosis or suspicion of diagnosis. IV. To compare outcomes between academic and community centers separately. V. To evaluate factors associated with outcome. OUTLINE: Patients receive standard of care treatment for APL. Patients and doctors regularly discuss with an APL expert to identify and mange treatment. After diagnosis, patients are followed up for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
202
Treatment per Acute Promyelocytic Leukemia (APL) Treatment Guidelines plus discussion between doctors and APL expert
Correlative studies
One-month Mortality Rate
Proportion of patients died within one month from the first date of induction therapy.
Time frame: Assessed at one month
Survival Rate at One Year
Overall survival is defined as the time from the first date of induction therapy to death or date last known alive. Proportion of patients alive at one year was estimated using the method of Kaplan and Meier.
Time frame: Assessed at one year
One-month Survival Rate by Lead Academic Sites and Community Sites
Proportion of patients who are alive at one month since the first date of induction therapy by lead academic sites and community sites
Time frame: Assessed at one month
Differentiation Syndrome Rate
The proportion of patients with differentiation syndrome (measured based on the CTC version 4.0) will be evaluated.
Time frame: Assessed up to 1 year
Association Between One-month Mortality Rate and Time From Diagnosis to Initiation of All-trans Retinoic Acid (ATRA)
The time from diagnosis and initiation of ATRA will be assessed and dichotomized as "short' vs. "long" using the median value. One-month mortality rate will be compared in these two groups (short vs. long) using the Fisher's exact test.
Time frame: Assessed at one month
Association Between One-month Survival and Baseline Factors
The associations between one-month survival and baseline factors will be evaluated.
Time frame: Assessed at baseline and one month
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