Simplified Patient Care Strategy in Decreasing Early Death in Patients With Acute Promyelocytic Leukemia

Not Applicable

Active, not recruiting

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Confirmed to have a diagnosis of APL, which is defined as:
- Positive t(15:17) by fluorescence in situ hybridization (FISH) or conventional karyotype
- Positive promyelocytic leukemia/retinoic acid receptor PML/RAR alpha by polymerase chain reaction (PCR)
Patients must accept treatment and supportive care guidelines
Referrals must be made as early as possible but no later than 5 calendar days after ATRA therapy is initiated; consent can be obtained up till day 7 or earlier
Co-management can be started as soon as referral is made including weekends; the physician at the outlying facility should make every effort to call the APL expert at the first suspicion of APL

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
One-month Mortality Rate	Assessed at one month	Proportion of patients died within one month from the first date of induction therapy.

Secondary Outcome Measures

Name	Time	Method
Survival Rate at One Year	Assessed 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.
Association Between One-month Survival and Baseline Factors	Assessed at baseline and one month	The associations between one-month survival and baseline factors will be evaluated.
One-month Survival Rate by Lead Academic Sites and Community Sites	Assessed at one month	Proportion of patients who are alive at one month since the first date of induction therapy by lead academic sites and community sites
Differentiation Syndrome Rate	Assessed up to 1 year	The proportion of patients with differentiation syndrome (measured based on the CTC version 4.0) will be evaluated.
Association Between One-month Mortality Rate and Time From Diagnosis to Initiation of All-trans Retinoic Acid (ATRA)	Assessed at one month	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.

Locations (294): Fairbanks Memorial Hospital
🇺🇸
Fairbanks, Alaska, United States
Kaiser Permanente-Anaheim
🇺🇸
Anaheim, California, United States
Kaiser Permanente-Deer Valley Medical Center
🇺🇸
Antioch, California, United States
Kaiser Permanente-Baldwin Park
🇺🇸
Baldwin Park, California, United States
Kaiser Permanente-Bellflower
🇺🇸
Bellflower, California, United States
Kaiser Permanente-Fontana
🇺🇸
Fontana, California, United States
Kaiser Permanente-Fremont
🇺🇸
Fremont, California, United States
Fresno Cancer Center
🇺🇸
Fresno, California, United States
Kaiser Permanente-Fresno
🇺🇸
Fresno, California, United States
Kaiser Permanente - Harbor City
🇺🇸
Harbor City, California, United States
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Fairbanks Memorial Hospital
🇺🇸Fairbanks, Alaska, United States