Acute promyelocytic leukemia

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ORPHA:520OMIM:612376C92.4
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2FDA treatments33Active trials98Specialists8Treatment centers2Financial resources

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Acute promyelocytic leukemia (APL), also known as acute myeloid leukemia M3 or AML-M3, is a fast-moving type of blood cancer that affects the bone marrow — the spongy tissue inside your bones where blood cells are made. In APL, immature white blood cells called promyelocytes build up in the bone marrow and blood instead of developing into healthy, mature cells. This buildup crowds out normal blood cells, leading to serious problems with bleeding and infection. APL is caused by a specific chromosomal change in the leukemia cells: a swap of genetic material between chromosomes 15 and 17, written as t(15;17). This creates an abnormal gene called PML-RARA, which blocks blood cell development. The most dangerous feature of APL is a life-threatening bleeding disorder that can develop very quickly, making early diagnosis and treatment absolutely critical. The good news is that APL has become one of the most treatable forms of leukemia. With modern therapy using all-trans retinoic acid (ATRA) and arsenic trioxide (ATO), most patients achieve complete remission. Cure rates now exceed 80-90% in many patients, making APL a remarkable success story in cancer medicine. Early recognition and urgent treatment are key to the best outcomes.

Also known as:

Key symptoms:

Unusual or easy bruisingHeavy or prolonged bleeding from cuts or minor injuriesNosebleeds that are hard to stopBleeding gumsTiny red or purple spots on the skin (petechiae)Extreme tiredness and weaknessPale skinFrequent infections or feversShortness of breathSwollen lymph nodes (less common than in other leukemias)Bone or joint painHeadache or confusion (if bleeding occurs in the brain)

Clinical phenotype terms (36)— hover any for plain English
Disseminated intravascular coagulationHP:0005521Bone marrow hypercellularityHP:0031020Chronic infectionHP:0031035
Inheritance

Sporadic

Usually appears on its own, not inherited from a parent

Age of Onset

Adult

Begins in adulthood (age 18 or older)

Orphanet ↗OMIM ↗NORD ↗

FDA & Trial Timeline

10 events
Mar 2026Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML

The First Affiliated Hospital of Soochow University — PHASE3

TrialNOT YET RECRUITING
Mar 2026Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia

Quetzal Therapeutics — PHASE3

TrialRECRUITING
Jan 2026A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)

SDK Therapeutics, Inc. — PHASE3

TrialNOT YET RECRUITING
Dec 2025Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)

Stichting Hemato-Oncologie voor Volwassenen Nederland — PHASE3

TrialNOT YET RECRUITING
Nov 2025Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

Syndax Pharmaceuticals — PHASE3

TrialRECRUITING
Jul 2025Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia

Anhui Medical University — NA

TrialACTIVE NOT RECRUITING
Jun 2025A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Janssen Research & Development, LLC — PHASE3

TrialRECRUITING
Jun 2025Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

Gruppo Italiano Malattie EMatologiche dell'Adulto — PHASE2

TrialNOT YET RECRUITING
Jun 2025Early Use of Realgar-Indigo Naturalis Formula (RIF) Combined With All-trans Retinoic Acid (ATRA) for Treating Acute Promyelocytic Leukemia (APL).

First Affiliated Hospital Xi'an Jiaotong University — PHASE3

TrialRECRUITING
Mar 2025L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML

Moleculin Biotech, Inc. — PHASE2, PHASE3

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

2 available

Trisenox

Arsenic trioxide· Teva Branded Pharmaceutical Products R&D, Inc.■ Boxed WarningOrphan Drug
For induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is

For induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation of PML/RAR-alpha gene expression.

Vesanoid

Tretinoin· Hoffmann-La Roche, Inc.■ Boxed WarningOrphan Drug

Induction of remission in patients with acute promyelocytic leukemia who are refractory to or unable to tolerate anthracycline based cytotoxic chemotherapeutic regimens.

Clinical Trials

20 recruitingView all trials with filters →
Phase 311 trials
A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy
Phase 3
Active
PI: B.J. Wouters (Erasmus MC / HOVON) · Sites: Adelaide; Adelaide +179 more · Age: 1899 yrs
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Phase 3
Actively Recruiting
PI: Seth Karol, MD (St. Jude Children's Research Hospital) · Sites: Phoenix, Arizona; Little Rock, Arkansas +87 more · Age: 021 yrs
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
Phase 3
Actively Recruiting
PI: Todd M Cooper (Children's Oncology Group) · Sites: Birmingham, Alabama; Mobile, Alabama +203 more · Age: 021 yrs
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Phase 3
Actively Recruiting
PI: Global Clinical Leader (Daiichi Sankyo) · Sites: Goodyear, Arizona; Phoenix, Arizona +290 more · Age: 1870 yrs
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
Phase 3
Active
PI: Matthew A Kutny (Children's Oncology Group) · Sites: Birmingham, Alabama; Mobile, Alabama +172 more · Age: 021 yrs
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
Phase 3
Active
PI: M. Raaijmakers, Prof. Dr. (Erasmus MC / HOVON) · Sites: Adelaide; Adelaide +191 more · Age: 1899 yrs
Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML
Phase 3
Actively Recruiting
· Sites: Alessandria; Ancona +46 more · Age: 1860 yrs
Early Use of Realgar-Indigo Naturalis Formula (RIF) Combined With All-trans Retinoic Acid (ATRA) for Treating Acute Promyelocytic Leukemia (APL).
Phase 3
Actively Recruiting
· Sites: Xi'an, Shaanxi · Age: 1880 yrs
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Phase 3
Actively Recruiting
· Sites: Duarte, California; The Bronx, New York · Age: 1871 yrs
Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia
Phase 3
Active
PI: Avinash Desai, MD (Actinium Pharmaceuticals) · Sites: Gilbert, Arizona; New Haven, Connecticut +22 more · Age: 5599 yrs
A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
Phase 3
Actively Recruiting
PI: Jianxiang Wang, M.D. (Hematology Hospital of the Chinese Academy of Medi) · Sites: Tianjin, Tianjin Municipality; Hangzhou, Zhejiang +4 more · Age: 1899 yrs
Phase 23 trials
Evaluation of 3 Different Doses of IV Busulfan
Phase 2
Active
PI: Didier BLAISE, MD PhD (Institut Paoli-Calmettes) · Sites: Marseille · Age: 1865 yrs
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Phase 2
Actively Recruiting
PI: Fanco Locatelli, Prof (Dept. of Pediatric Hematology Oncology - Bambino G) · Sites: Brussels; Prague +29 more · Age: 018 yrs
Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML
Phase 2
Actively Recruiting
PI: Jianyu Weng (Guangdong Provincial People Hosptial) · Sites: Dongguan, Guangdong; Foshan, Guangdong +11 more · Age: 1899 yrs
Other4 trials
RWE of 1st Line Treatment With ATO/ATRA for Adult APL
Actively Recruiting
PI: María José Mela Osorio, Dr. (Grupo Argentino de Tratamiento de la Leucemia Agud) · Sites: La Plata, Buenos Aires; Paraná, Entre Ríos Province +4 more · Age: 1899 yrs
Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia
Active
PI: Wendy Stock, MD (University of Chicago) · Sites: San Diego, California; San Francisco, California +49 more
French Registry of First-line Treatment of Acute Promyelocytic Leukemia
Active
PI: Pierre FENAUX, MD (French APL Cooperative Group) · Sites: Aix-en-Provence; Amiens +25 more · Age: 070 yrs
Biological, Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 Ligand and IL6 of Patients Treated With Non-intensive Chemotherapy
Actively Recruiting
· Sites: Nantes, Loire-Atlantique · Age: 1899 yrs

Specialists

Showing 25 of 98View all specialists →
EP
Eduardo M Rego, MD PhD
Specialist
PI on 1 active trial
HM
Harry Gill, MD
FRESNO, CA
Specialist
PI on 1 active trial
GU
Geoffrey L Uy
SAINT LOUIS, MO
Specialist
PI on 1 active trial
JP
John F. DiPersio, MD, PhD
SAINT LOUIS, MO
Specialist
PI on 1 active trial
BW
Brigitte C Widemann
BETHESDA, MD
Specialist
PI on 1 active trial12 Acute promyelocytic leukemia publications
LD
Lowenberg Bob, Dr
Specialist
PI on 1 active trial
VD
Vellenga Edo, Dr
Specialist
PI on 1 active trial
XP
Xue-Qun Luo, professor
Specialist
PI on 1 active trial
FR
Farhad Ravandi-Kashani
HOUSTON, TX
Specialist
PI on 7 active trials2 Acute promyelocytic leukemia publications
MF
Maryam Fouladi
COLUMBUS, OH
Specialist
PI on 7 active trials2 Acute promyelocytic leukemia publications
CD
Colleen Delaney
OLD GREENWICH, CT
Specialist
PI on 3 active trials
DM
Dan Douer, MD
NEW YORK, NY
Specialist
PI on 3 active trials
TH
Terzah Horton
HOUSTON, TX
Specialist
PI on 2 active trials
ES
Eisai Medical Services
Specialist
PI on 3 active trials
MM
Mignon Loh, MD
SAN FRANCISCO, CA
Specialist
PI on 2 active trials

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Financial Resources

2 resources
Trisenox(Arsenic trioxide)Teva Branded Pharmaceutical Products R&D, Inc.
Vesanoid(Tretinoin)Hoffmann-La Roche, Inc.

Travel Grants

No travel grants are currently matched to Acute promyelocytic leukemia.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Acute promyelocytic leukemia

1 articles
NewsCLIN HEMATOL INTJan 1, 2026
Leukemia cutis and all-trans retinoic acid-induced myocarditis in acute promyelocytic leukemia
Published in Clin Hematol Int. Rahbari KJ et al.
See all news about Acute promyelocytic leukemia

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.What is my risk category (low, intermediate, or high risk), and how does that affect my treatment plan?,Will I need chemotherapy in addition to ATRA and arsenic trioxide?,How will you monitor whether my treatment is working, and what does a PCR test result mean for me?,What are the signs of the dangerous bleeding disorder (DIC), and what should I do if I notice them?,What are the short-term and long-term side effects of arsenic trioxide and ATRA that I should watch for?,What is my expected chance of cure, and what happens if the leukemia comes back?,Are there any clinical trials I should consider, especially if I am high-risk or if treatment doesn't work?

Common questions about Acute promyelocytic leukemia

What is Acute promyelocytic leukemia?

Acute promyelocytic leukemia (APL), also known as acute myeloid leukemia M3 or AML-M3, is a fast-moving type of blood cancer that affects the bone marrow — the spongy tissue inside your bones where blood cells are made. In APL, immature white blood cells called promyelocytes build up in the bone marrow and blood instead of developing into healthy, mature cells. This buildup crowds out normal blood cells, leading to serious problems with bleeding and infection. APL is caused by a specific chromosomal change in the leukemia cells: a swap of genetic material between chromosomes 15 and 17, writte

How is Acute promyelocytic leukemia inherited?

Acute promyelocytic leukemia follows a sporadic inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Acute promyelocytic leukemia typically begin?

Typical onset of Acute promyelocytic leukemia is adult. Age of onset can vary across affected individuals.

Are there clinical trials for Acute promyelocytic leukemia?

Yes — 20 recruiting clinical trials are currently listed for Acute promyelocytic leukemia on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Acute promyelocytic leukemia?

25 specialists and care centers treating Acute promyelocytic leukemia are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.

What treatment and support options exist for Acute promyelocytic leukemia?

2 patient support programs are currently tracked on UniteRare for Acute promyelocytic leukemia. See the treatments and support programs sections for copay assistance, eligibility, and contact details.