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

Inclusion Criteria

• Confirmed to have a diagnosis of APL, which is defined as: * Positive t(15:17) by fluorescence in situ hybridization (FISH) OR * Positive t(15:17) by conventional karyotype, OR * 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 by treating physician (provider) but no later than 3 calendar days after ATRA or APL directed therapy is initiated; consent can be obtained up until day 7 after initiating APL directed therapy
• Co-management can be started as soon as referral is made including weekends; the physician at the National Cancer Institute Community Oncology Research Program (NCORP) community facility should make every effort to call the APL expert at the first suspicion of APL

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.

Trial Phase Phase NA

Trial Type Prevention

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Anand P. Jillella

• Primary ID EA9131
• Secondary IDs NCI-2016-01123, ECOG-ACRIN-EA9131
• Clinicaltrials.gov ID NCT03253848