Active, not yet recruiting
A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)
NCT No.: NCT03253848
Study Type: OBSERVATIONAL
Phase:
Region: California - Northern
Acronym: ECOG EA9131
Official Title
A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)
Purpose
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.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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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
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Exclusion Criteria
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Please contact the study team for exclusion criteria.
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Keywords and/or Specific Medical Conditions
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Leukemia, Promyelocytic, Acute
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Neoplasms by Histologic Type
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Sponsors
- Eastern Cooperative Oncology Group
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