Simplified Patient Care Strategy in Decreasing Early Death in Patients with Acute Promyelocytic Leukemia
Hematopoietic Malignancies
Leukemia
Unknown Primary
18 Years and older, Male and Female
IRB00067432 (primary)
WINSHIP2488-13
EA9131
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.
Eligibility
- 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
Treatment Sites in Georgia
**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.