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
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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