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


Active: No
Cancer Type: Hematopoietic Malignancies
Leukemia
Unknown Primary
NCT ID: NCT02309333
Trial Phases: Protocol IDs: IRB00067432 (primary)
WINSHIP2488-13
EA9131
Eligibility: 18 Years and older, Male and Female Study Type: Prevention
Study Sponsor: ECOG-ACRIN Cancer Research Group
NCI Full Details: http://clinicaltrials.gov/show/NCT03253848

Summary

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.