Clinical trial · Interventional
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)
NCT03253848CI-TRIAL-00120946active not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Promyelocytic Leukemia With PML-RARA | Acute Promyelocytic Leukemia with t(15;17)(q24.1;q21.2); PML-RARA | CURATED_BROADER | 0.80 |
| t(15;17) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Simplified Patient Care Strategy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Simplified Patient Care Strategy plus APL Expert Support
- description
- Patients receive standard of care treatment for APL. Treating physicians regularly discuss with an APL expert to identify and mange treatment.
- interventionNames
- Other: Simplified Patient Care Strategy
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- One-month Mortality Rate
- timeFrame
- Assessed at one month
- description
- Proportion of patients died within one month from the first date of induction therapy.
Secondary outcomes (5)
- measure
- Survival Rate at One Year
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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
References
Publications (1)
- DERIVEDJillella AP, Lee SJ, Altman JK, Luger SM, Tallman MS, Foran JM, Bradshaw D, Law LY, Bryan LJ, Abou Zahr A, Begna KH, Perl AE, Vadakara JJL, Qamar R, Bergan RC, Fisch MJ, Carlos RC, Wagner LI, Kota VK, Litzow MR. Academic Community Partnership in Acute Promyelocytic Leukemia and Early Mortality: The ECOG-ACRIN EA9131 Trial. JAMA Oncol. 2025 Feb 27;11(4):400-7. doi: 10.1001/jamaoncol.2024.7033. Online ahead of print. PMID 40014329