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

ECOG-ACRIN Cancer Research Group

Status: Active, not recruiting

Conditions: Acute Promyelocytic Leukemia With PML-RARA; t(15;17)

Treatments: Other: Laboratory Biomarker Analysis; Other: Simplified Patient Care Strategy

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT03253848

NCI-2016-01123 (Registry Identifier)

EA9131 (Other Identifier)

U10CA037403 (U.S. NIH Grant/Contract)

UG1CA189828 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

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

After diagnosis, patients are followed up for 1 year.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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202 participants in 1 patient group

Simplified Patient Care Strategy plus APL Expert Support

Experimental group

Description:

Patients receive standard of care treatment for APL. Treating physicians regularly discuss with an APL expert to identify and mange treatment.

Treatment:

Other: Simplified Patient Care Strategy

Other: Laboratory Biomarker Analysis