Clinical trial · Observational
Impact of a Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL) by Maintaining a Database
Assessing the Impact of a Simplified Patient Care Strategy to Decrease Early Deaths In Acute Promyelocytic Leukemia (APL) By Maintaining A Database
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Previous principal investigators left institution
Summary
Brief summary (as posted)
Acute promyelocytic leukemia (APL) is a very rare type of leukemia. Because it is so rare, many doctors do not have experience treating it. APL has been shown to be curable most of the time. Unfortunately, some patients die early after they become sick with APL, sometimes even before starting treatment. The early period is from the time of diagnosis through the first treatments for the disease. This is approximately 30 days. Early deaths are often due to complications caused by of the effects of leukemia and the treatments of it. These complications may not be noticed quickly by doctors who don't have much experience with managing APL. The purpose of this study is to collect information about the diagnosis and management of APL patients by review of their medical records. This information will be stored in a central database at Emory University. This data will be analyzed to discover the impact of increased physician knowledge of recommended management of APL. The goal is to reduce the events of early death of APL patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Promyelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Mortality in the first month after diagnosis
- timeFrame
- 1 month after diagnosis
Secondary outcomes (8)
- measure
- Overall survival 18 months after accrual is completed
- timeFrame
- 18 months after accrual completion
- measure
- Severity and duration of coagulopathy
- timeFrame
- 5 years from start of trial
- description
- Assessment of the severity and duration of coagulopathy, including presence or absence of clinically evident bleeding or bruising, and laboratory data including prothrombin time, activated partial thromboplastin time, international normalized ratio (INR), D-dimer, and fibrinogen
- measure
- Mortality with the severity and duration of coagulopathy
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of APL * Positive t (15:17) by fluorescence in situ hybridization (FISH) * Promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha by polymerase chain reaction (PCR) Exclusion Criteria: * Only patients who refuse to provide consent will be excluded from the study
References
Publications (1)
- DERIVEDJillella AP, Arellano ML, Gaddh M, Langston AA, Heffner LT, Winton EF, McLemore ML, Zhang C, Caprara CR, Simon KS, Bolds SL, DeBragga S, Karkhanis P, Krishnamurthy SH, Tongol J, El Geneidy MM, Pati A, Gerber JM, Grunwald MR, Cortes J, Bashey A, Stuart RK, Kota VK. Comanagement Strategy Between Academic Institutions and Community Practices to Reduce Induction Mortality in Acute Promyelocytic Leukemia. JCO Oncol Pract. 2021 Apr;17(4):e497-e505. doi: 10.1200/OP.20.00395. Epub 2020 Oct 30. PMID 33125295