Leukemia, Acute Promyelocytic (EA9131) Observational

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

Objective

Overview

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.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

• Confirmed to have a diagnosis of APL, which is defined as:

  • Positive t(15:17) by fluorescence in situ hybridization (FISH) or conventional karyotype
  • 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 but no later than 5 calendar days after ATRA therapy is initiated; consent can be obtained up till day 7 or earlier
• Co-management can be started as soon as referral is made including weekends; the physician at the outlying facility should make every effort to call the APL expert at the first suspicion of APL

Study Type: Observational

Learn More

ClinicalTrials.Gov

IRB Protocol Number

EA9131

Principal Investigator(s)

Asim Pati, M.D

Clinical Trial Categories

• Oncology
• Hematologic Cancer

Sponsor(s)

ECOG-ACRIN Cancer Research Group

Contact

Wanda Burdette, RN at 864-560-6810
or wburdette@gibbscc.org

How to Participate

Wanda Burdette, RN

864-560-6810

wburdette@gibbscc.org