Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT03253848

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

A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
202 (actual)
Sponsor
ECOG-ACRIN Cancer Research Group · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSimplified Patient Care StrategyTreatment per Acute Promyelocytic Leukemia (APL) Treatment Guidelines plus discussion between doctors and APL expert
OTHERLaboratory Biomarker AnalysisCorrelative studies

Timeline

Start date
2017-09-26
Primary completion
2023-04-27
Completion
2027-12-31
First posted
2017-08-18
Last updated
2026-04-02
Results posted
2025-04-11

Locations

294 sites across 2 countries: United States, Puerto Rico

Source: ClinicalTrials.gov record NCT03253848. Inclusion in this directory is not an endorsement.