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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 : November 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Tracking Information
First Submitted Date August 16, 2017
First Posted Date August 18, 2017
Last Update Posted Date November 21, 2018
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
 (submitted: August 16, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03253848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 16, 2017)
  • Compliance with treatment guidelines [ Time Frame: Up to 1 year ]
    Will be assessed as binary outcome and the successful compliance rate will be described with 95% confidence interval. A regression model will be developed to evaluate the factors associated with outcome. Data items such as age, risk status, comorbidity will be collected and evaluated.
  • Length of hospital stay [ Time Frame: Up to 1 year ]
    Will be associated with toxicity measures. Will be dichotomized as ?mild? versus (vs.) ?severe? and the length of hospital stay will be compared using the two-sample t-test.
  • Mortality rate [ Time Frame: At 1 month ]
    Will be compared between patients with long time or short time from diagnosis to treatment using the Fisher?s exact test. Will also be compared between lead institutions and outlying centers.
  • Overall survival [ Time Frame: At 1 month ]
    Will be compared between the lead institutions and outlying centers and two-sided p-values will be reported.
  • Overall survival (OS) [ Time Frame: At 1 year ]
    Will be described using the method of Kaplan-Meier. The median OS and one-year OS rate will be estimated and 95% confidence interval (CI) will be provided.
  • Severity and duration of coagulopathy, bleeding, infections, and differentiation syndrome [ Time Frame: Up to 1 year ]
    Will be measured based on the Common Terminology Criteria for Adverse Events version 4.0. Analysis of the safety data will be mostly descriptive. The proportion of patients with the worst degree toxicity of grade 3 or higher will be assessed and presented with 95% CI.
  • Time from diagnosis and initiation of treatment [ Time Frame: Up to 1 year ]
    Will be assessed and dichotomized as ?short? vs. ?long? using the median value.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
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
  • Acute Promyelocytic Leukemia With PML-RARA
  • t(15;17)
Intervention
  • Other: Best Practice
    Discussion between doctors and APL expert
    Other Names:
    • standard of care
    • standard therapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Procedure: Supportive Care
    Receive simplified guidelines and support
    Other Names:
    • Supportive Therapy
    • Symptom Management
    • Therapy, Supportive
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:
  • Other: Best Practice
  • Other: Laboratory Biomarker Analysis
  • Procedure: Supportive Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 16, 2017)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries 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 )
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
Principal Investigator: Anand Jillella ECOG-ACRIN Cancer Research Group
PRS Account Eastern Cooperative Oncology Group
Verification Date November 2018