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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 )

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.

Condition or disease Intervention/treatment
Acute Promyelocytic Leukemia With PML-RARA t(15;17) Other: Best Practice Other: Laboratory Biomarker Analysis Procedure: Supportive Care

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
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : August 18, 2022
Estimated Study Completion Date : August 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Group/Cohort Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with confirmed APL 18 years and over.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253848


  Show 113 Study Locations
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anand Jillella ECOG-ACRIN Cancer Research Group

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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT03253848     History of Changes
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 )
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid