This research 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.
Additional locations may be listed on ClinicalTrials.gov for NCT03253848.
See trial information on ClinicalTrials.gov for a list of participating sites.
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 PhaseNo phase specified
Trial Typeprevention
Lead OrganizationECOG-ACRIN Cancer Research Group
Principal InvestigatorAnand P. Jillella
