Simplified Patient Care Strategy in Decreasing Early Death in Patients With Acute Promyelocytic Leukemia
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ClinicalTrials.gov Identifier: NCT03253848 |
Recruitment Status :
Recruiting
First Posted : August 18, 2017
Last Update Posted : March 9, 2021
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Tracking Information | ||||
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First Submitted Date | August 16, 2017 | |||
First Posted Date | August 18, 2017 | |||
Last Update Posted Date | March 9, 2021 | |||
Actual Study Start Date | August 16, 2017 | |||
Estimated Primary Completion Date | August 18, 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Mortality rate [ Time Frame: At 1 month ] Will be estimated by dividing total number of deaths within one month of study entry by total number of cases with at least one-month follow up data. 95% repeated confidence interval will be provided.
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Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Simplified Patient Care Strategy in Decreasing Early Death in Patients With Acute Promyelocytic Leukemia | |||
Official Title | A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL) | |||
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 leukemia guidelines along with support from acute promyelocytic leukemia experts may decrease deaths and improve survival. | |||
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-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. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients with confirmed APL 18 years and over. | |||
Condition |
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Intervention |
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Study Groups/Cohorts | Observational (simplified guidelines and support)
Patients receive standard of care treatment for APL. Patients? doctors regularly discuss with an APL expert to identify and mange treatment.
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Recruiting | |||
Estimated Enrollment |
200 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | August 18, 2025 | |||
Estimated Primary Completion Date | August 18, 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | ||||
Listed Location Countries | Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT03253848 | |||
Other Study ID Numbers | EA9131 NCI-2016-01123 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) EA9131 ( Other Identifier: ECOG-ACRIN Cancer Research Group ) ECOG-ACRIN-EA9131 ( Other Identifier: DCP ) EA9131 ( Other Identifier: CTEP ) UG1CA189828 ( U.S. NIH Grant/Contract ) U10CA037403 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ) | |||
Study Sponsor | ECOG-ACRIN Cancer Research Group | |||
Collaborators | National Cancer Institute (NCI) | |||
Investigators |
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PRS Account | Eastern Cooperative Oncology Group | |||
Verification Date | May 2020 |