AzTrials
AzTrials

Acute Promyelocytic Leukemia With PML-RARANCT03253848

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

A study testing Simplified Patient Care Strategy and Laboratory Biomarker Analysis in people with Acute Promyelocytic Leukemia With PML-RARA and t(15;17), run by ECOG-ACRIN Cancer Research Group at 294 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Simplified Patient Care Strategy and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
294 sitesin 2 countries
Study dates
26 Sep 2017to 31 Dec 2027
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

294 sites in 2 countries.

294 sites in 2 countries

United States282 sites

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • McFarland Clinic PC-Boone

    Boone, Iowa, 50036

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Northwestern University

    Chicago, Illinois, 60611

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Aurora Saint Luke's South Shore

    Cudahy, Wisconsin, 53110

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Dekalb Medical Center

    Decatur, Georgia, 30033

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Cancer Center of Colorado at Sloan's Lake

    Denver, Colorado, 80204

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Main Line Health Center-Exton

    Exton, Pennsylvania, 19341

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • McFarland Clinic PC-Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Fresno Cancer Center

    Fresno, California, 93720

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Rocky Mountain Cancer Centers-Greenwood Village

    Greenwood Village, Colorado, 80111

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Essentia Health - Jamestown Clinic

    Jamestown, North Dakota, 58401

  • McFarland Clinic PC-Jefferson

    Jefferson, Iowa, 50129

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Good Samaritan Medical Center

    Lafayette, Colorado, 80026

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Kansas Institute of Medicine Cancer and Blood Center

    Lenexa, Kansas, 66219

  • Minimally Invasive Surgery Hospital

    Lenexa, Kansas, 66219

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente-Cadillac

    Los Angeles, California, 90034

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • McFarland Clinic PC-Marshalltown

    Marshalltown, Iowa, 50158

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Kaiser Permanente Oakland-Broadway

    Oakland, California, 94611

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Essentia Health - Park Rapids

    Park Rapids, Minnesota, 56470

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Jefferson Healthcare

    Port Townsend, Washington, 98368

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Kaiser Permanente-Rancho Cordova Cancer Center

    Rancho Cordova, California, 95670

  • Kaiser Permanente-Redwood City

    Redwood City, California, 94063

  • Lakeview Medical Center-Marshfield Clinic

    Rice Lake, Wisconsin, 54868

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Kaiser Permanente-Richmond

    Richmond, California, 94801

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • Riverton Hospital

    Riverton, Utah, 84065

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • The Permanente Medical Group-Roseville Radiation Oncology

    Roseville, California, 95678

  • Kaiser Permanente Downtown Commons

    Sacramento, California, 95814

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • South Sacramento Cancer Center

    Sacramento, California, 95823

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Kaiser Permanente-San Diego Mission

    San Diego, California, 92108

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Low Country Cancer Care Associates PC

    Savannah, Georgia, 31405

  • Summit Cancer Care-Candler

    Savannah, Georgia, 31405

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Kaiser Permanente Cancer Treatment Center

    South San Francisco, California, 94080

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown

    Spokane, Washington, 99204

  • MultiCare Deaconess Cancer and Blood Specialty Center - North

    Spokane, Washington, 99218

  • MultiCare Deaconess Cancer and Blood Specialty Center - Valley

    Spokane Valley, Washington, 99216

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Marshfield Clinic Stevens Point Center

    Stevens Point, Wisconsin, 54482

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Kaiser Permanente-Stockton

    Stockton, California, 95210

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Aurora Medical Center in Summit

    Summit, Wisconsin, 53066

  • Missouri Baptist Outpatient Center-Sunset Hills

    Sunset Hills, Missouri, 63127

  • Southwest Illinois Health Services LLP

    Swansea, Illinois, 62226

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington, 98405

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • Sanford Thief River Falls Medical Center

    Thief River Falls, Minnesota, 56701

  • National Jewish Health-Northern Hematology Oncology

    Thornton, Colorado, 80260

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241

  • MGC Hematology Oncology-Union

    Union, South Carolina, 29379

  • Kaiser Permanente Medical Center-Vacaville

    Vacaville, California, 95688

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596

  • Aurora Cancer Care-Milwaukee West

    Wauwatosa, Wisconsin, 53226

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • SCL Health Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Kaiser Permanente-Woodland Hills

    Woodland Hills, California, 91367

  • Sanford Cancer Center Worthington

    Worthington, Minnesota, 56187

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

Other trials in United States

Puerto Rico12 sites

  • Advance Oncology Center

    Aguadilla, 00603

  • Doctor's Cancer Center-Arecibo

    Arecibo, 00614

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060

  • Hematologia Oncologia San Pablo

    Bayamón, 00961

  • HIMA San Pablo Oncologic Hospital

    Caguas, 00726

  • Doctors Cancer Center

    Manati, 00674

  • Instituto Oncologia Moderna Ponce

    Ponce, 00716

  • San Juan Community Oncology Group

    San Juan, 00917

  • Primary Care Physician Group

    San Juan, 00920

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

  • San Juan City Hospital

    San Juan, 00936

  • Centro de Hematologia y Oncologia del Sur

    Santa Isabel, 00757

Other trials in Puerto Rico

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Simplified Patient Care Strategy, Laboratory Biomarker Analysis
Medical subject headings
Leukemia, Promyelocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simplified Patient Care StrategyOther

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

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT03253848
Study groupRoleWhat they receive
Simplified Patient Care Strategy plus APL Expert SupportExperimentalPatients receive standard of care treatment for APL. Treating physicians regularly discuss with an APL expert to identify and mange treatment.
Receives: Other: Simplified Patient Care Strategy; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. One-month Mortality Rate

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

    Measured: Assessed at one month

Secondary outcomes (5)

  1. Survival Rate 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.

    Measured: Assessed at one year

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

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

    Measured: Assessed at one month

  3. Differentiation Syndrome Rate

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

    Measured: Assessed up to 1 year

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

    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.

    Measured: Assessed at one month

  5. Association Between One-month Survival and Baseline Factors

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

    Measured: Assessed at baseline and one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2017
  2. Study start26 Sep 2017
  3. Primary completion27 Apr 2023
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03253848
Sponsor's protocol ID
EA9131
Other IDs
NCI-2016-01123, EA9131, EA9131, UG1CA189828, U10CA037403
Status last verified
Jul 2026
First submitted
16 Aug 2017
Last updated
6 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Publications

  • Jillella AP, Lee SJ, Altman JK, Luger SM, Tallman MS, Foran JM, Bradshaw D, Law LY, Bryan LJ, Abou Zahr A, Begna KH, Perl AE, Vadakara JJL, Qamar R, Bergan RC, Fisch MJ, Carlos RC, Wagner LI, Kota VK, Litzow MR. Academic Community Partnership in Acute Promyelocytic Leukemia and Early Mortality: The ECOG-ACRIN EA9131 Trial. JAMA Oncol. 2025 Feb 27;11(4):400-7. doi: 10.1001/jamaoncol.2024.7033. Online ahead of print.

    PubMed 40014329

Questions about this trial

What is this clinical trial studying?

A study testing Simplified Patient Care Strategy and Laboratory Biomarker Analysis in people with Acute Promyelocytic Leukemia With PML-RARA and t(15;17), run by ECOG-ACRIN Cancer Research Group at 294 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 294 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

One-month Mortality Rate (time frame: Assessed at one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03253848, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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