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NCT Number: NCT03253848

Simplified Patient Care Strategy in Decreasing Early Death in Patients With Acute Promyelocytic Leukemia

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Promyelocytic Leukemia With PML-RARA Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Neoplasms Neoplasms by Histologic Type t(15;17)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advance Oncology Center, Aguadilla, Puerto Rico

Loading trial locations.

About this study

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 and doctors regularly discuss with an APL expert to identify and mange treatment.

After diagnosis, patients are followed up for 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simplified Patient Care Strategy

Other

Treatment per Acute Promyelocytic Leukemia (APL) Treatment Guidelines plus discussion between doctors and APL expert

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. One-month Mortality Rate

    Time frame: Assessed at one month

    Proportion of patients died within one month from the first date of induction therapy.

Secondary outcomes

  1. Survival Rate at One Year

    Time frame: Assessed at one year

    Overall survival is defined as the time from the first date of induction therapy to death or date last known alive. Proportion of patients alive at one year was estimated using the method of Kaplan and Meier.

  2. One-month Survival Rate by Lead Academic Sites and Community Sites

    Time frame: Assessed at one month

    Proportion of patients who are alive at one month since the first date of induction therapy by lead academic sites and community sites

  3. Differentiation Syndrome Rate

    Time frame: Assessed up to 1 year

    The proportion of patients with differentiation syndrome (measured based on the CTC version 4.0) will be evaluated.

  4. Association Between One-month Mortality Rate and Time From Diagnosis to Initiation of All-trans Retinoic Acid (ATRA)

    Time frame: Assessed at one month

    The time from diagnosis and initiation of ATRA will be assessed and dichotomized as "short' vs. "long" using the median value. One-month mortality rate will be compared in these two groups (short vs. long) using the Fisher's exact test.

  5. Association Between One-month Survival and Baseline Factors

    Time frame: Assessed at baseline and one month

    The associations between one-month survival and baseline factors will be evaluated.

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)

Important dates

Study start
2017
Primary completion
2023
Study completion
2027
First posted
Aug 18, 2017
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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