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

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? doctors regularly discuss with
an APL expert to identify and mange treatment.

After diagnosis, patients are followed up for 1 year.

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