Status:
ACTIVE_NOT_RECRUITING
Simplified Patient Care Strategy in Decreasing Early Death in Patients With Acute Promyelocytic Leukemia
Lead Sponsor:
ECOG-ACRIN Cancer Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Acute Promyelocytic Leukemia With PML-RARA
t(15;17)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 leukemi...
Detailed Description
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-mo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT03253848
Start Date
September 26 2017
End Date
December 31 2025
Last Update
November 24 2025
Active Locations (294)
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1
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
2
Kaiser Permanente-Anaheim
Anaheim, California, United States, 92806
3
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
4
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States, 91706