Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

NCT04778397 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: GS-US-546-58572020-003949-11jRCT2071220076
• Study Type: interventional
• Target: 258
• Locations: 14 countries
• Sites: 154

Brief Summary

The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy

  OS was measured from the date of randomization to the date of death from any cause. Deaths which were not observed during the study were censored at their last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis.

  Up to 2.1 years

Secondary Outcomes (11)

• Overall Survival in All Participants

  Up to 2.1 years

• Event-Free Survival (EFS) in All Participants

  Up to 2.1 years

• Rate of Complete Remission (CR) in All Participants

  Up to 2.1 years

• Rate of CR Without Minimal Residual Disease (CR MRD-) in All Participants

  Up to 2.1 years

• Rate of CR and CR With Partial Hematologic Recovery (CR+CRh) in All Participants

  Up to 2.1 years

Study Arms (3)

Magrolimab + Azacitidine

EXPERIMENTAL

Participants will receive an escalating dose of magrolimab and a fixed dose of azacitidine.

Drug: Magrolimab; Drug: Azacitidine

Control Arm: Venetoclax + Azacitidine

ACTIVE COMPARATOR

Participants who are appropriate for non-intensive therapy will receive an escalating dose of venetoclax and a fixed dose of azacitidine.

Drug: Venetoclax; Drug: Azacitidine

Control Arm: 7+3 Chemotherapy

ACTIVE COMPARATOR

Participants who are appropriate for intensive therapy will receive 7+3 chemotherapy: 7 day treatment with cytarabine and 3 day treatment with daunorubicin or idarubicin during induction and high-dose cytarabine and steroidal eye drops during consolidation.

Drug: Cytarabine; Drug: Daunorubicin; Drug: Idarubicin; Drug: Steroidal Eye Drops

Interventions

Magrolimab DRUG

Administered intravenously (IV).

Also known as: GS-4721

Magrolimab + Azacitidine

Venetoclax DRUG

Administered orally at a dose of 100 milligrams (mg) on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle (Cycle=28 days).

Control Arm: Venetoclax + Azacitidine

Azacitidine DRUG

Administered either subcutaneously (SC) or IV, 75 milligrams per square meter (mg/m\^2) on Days 1-7 or Days 1-5, 8 and 9 during every cycle (Cycle=28 days).

Control Arm: Venetoclax + Azacitidine; Magrolimab + Azacitidine

Cytarabine DRUG

Induction: administered continuous infusion, 100 or 200 mg/m\^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle (Cycle=Up to 42 Days). Consolidation: administered IV, 1500 or 3000 mg/m\^2 on Days 1, 3, and 5 once every 12 hours for up to 4 cycles.

Control Arm: 7+3 Chemotherapy

Daunorubicin DRUG

Administered IV peripherally (IVP), 60 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).

Control Arm: 7+3 Chemotherapy

Idarubicin DRUG

Administered IV, 12 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).

Control Arm: 7+3 Chemotherapy

Steroidal Eye Drops DRUG

Administered per institutional standard during consolidation.

Control Arm: 7+3 Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with confirmation of acute myeloid leukemia (AML) by World Health Organization criteria, previously untreated for AML, and who have presence of at least 1 TP53 gene mutation that is not benign or likely benign based on evaluation by either central laboratory or an approved local laboratory (after central review of the bone marrow TP53 mitigation next-generation sequencing test results) (individuals with biallelic 17p deletions, loss of both 17p alleles, are eligible based on locally evaluated cytogenetics/karyotype/fluorescence in situ hybridization (FISH) report).
• Individuals with white blood cell (WBC) count ≤ 20×10\^3/microliter (μL) prior to randomization. If the individual's WBC is \> 20×10\^3/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20×10\^3/μL prior to the first dose of study treatment and prior to each magrolimab dose the first 4 weeks (if the individual is randomized to the experimental arm) Note: Individuals can be treated with hydroxyurea and/or leukapheresis throughout the study or prior to randomization to reduce the WBC to ≤ 20×10\^3/μL to enable eligibility for study drug dosing.
• The hemoglobin must be ≥ 9 grams per deciliter (g/dL) prior to initial dose of study treatment.
• Notes: Transfusions are allowed to meet hemoglobin eligibility.
• Individual has provided informed consent.
• Individual is willing and able to comply with clinic visits and procedure outlined in the study protocol.
• Individuals must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, except for individuals less than 75 years of age and appropriate for non-intensive treatment. For these individuals, the ECOG performance status score may be 0 to 3.
• Individuals must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 milliliters per minute calculated by the Cockcroft Gault formula.
• Adequate cardiac function as demonstrated by:
• Lack of symptomatic congestive heart failure and clinically significant cardiac arrhythmias and ischemic heart disease.
• Left ventricular ejection fraction (LVEF) \> 50% for individuals appropriate for intensive therapy.
• Adequate liver function as demonstrated by:
• Aspartate aminotransferase ≤ 3.0 × upper limit of normal (ULN).
• Alanine aminotransferase ≤ 3.0 × ULN.
• Total bilirubin ≤ 1.5 × ULN, or primary unconjugated bilirubin ≤ 3.0 × ULN if individual has a documented history of Gilbert's syndrome or genetic equivalent.

You may not qualify if:

• Positive serum pregnancy test.
• Breastfeeding female.
• Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
• Prior treatment with any of the following:
• Cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα)-targeting agents
• Antileukemic therapy for the treatment of AML (excluding hydroxyurea), hypomethylating agent (HMA), low dose cytarabine and/or venetoclax.
• Individuals who are appropriate for intensive treatment but who have been previously treated with maximum cumulative doses of idarubicin and/or other anthracyclines and anthracenediones will be excluded.
• Individuals receiving any live vaccine within 4 weeks prior to initiation of study treatments.
• For individuals appropriate for intensive therapy, individuals treated with trastuzumab within 7 months prior to initiation of study treatments.
• Current participation in another interventional clinical study.
• Known inherited or acquired bleeding disorders.
• Individuals appropriate for non-intensive therapy, who have received treatment with strong and/or moderate cytochrome P450 enzyme 3A (CYP3A) inducers within 7 days prior to the initiation of study treatments.
• Individuals appropriate for non-intensive therapy who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days prior to the initiation of study treatment.
• Individuals appropriate for non-intensive therapy who have malabsorption syndrome or other conditions that preclude enteral route of administration.
• Clinical suspicion of active CNS involvement with AML.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (156)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, 91010, United States

Location

USC/ Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UC Irvine Health

Orange, California, 92868, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Memorial Cancer Institute

Pembroke Pines, Florida, 33028, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital/Main Lab

Chicago, Illinois, 60611, United States

Location

The University of Chicago Medical Centre

Chicago, Illinois, 60637, United States

Location

University of Kansas Hospital

Fairway, Kansas, 66205, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Tulane Medical center

New Orleans, Louisiana, 70112, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic Cancer Center Outpatient Pharmacy

Rochester, Minnesota, 55905, United States

Location

MidAmerica Division, Inc., c/o Research Medical Center

Kansas City, Missouri, 64132, United States

Location

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, 10032, United States

Location

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke Blood Cancer Center

Durham, North Carolina, 27705, United States

Location

The Ohio State University Wexner Medical Center/ James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Health Sciences Center - OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization

Philadelphia, Pennsylvania, 19107, United States

Location

St. Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

Prisma Health Cancer Institute

Greenville, South Carolina, 29615, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute ,The University of Utah

Salt Lake City, Utah, 84112, United States

Location

Froedtert Hospital / Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Calvary Master Newcastle

Waratah, New South Wales, 2298, Australia

Location

Westmead Hospital / Department of Haematology and Bone Marrow Transplantation

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Andrew Love Cancer Centre, University Hospital Geelong

Geelong, Victoria, 3220, Australia

Location

The Alfred

Melbourne, Victoria, 3004, Australia

Location

St Vincents Hospital Melbourne

Melbourne, Victoria, 3122, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Univ. -Klinik für Hämatologie und Internistische Onkologie, Kepler Universitätskilkun GmbHMed

Linz, 4021, Austria

Location

Uniklinikum Salzburg, Universitatsklinik f. Innere Medizin III der PMU

Salzburg, 5020, Austria

Location

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Grand Hôpital De Charleroi - Notre Dame

Charleroi, 6000, Belgium

Location

Universitaire Ziekenhuis Antwerpen

Edegem, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

AZ Delta vzw

Roeselare, 8800, Belgium

Location

Tom Baker Cancer Center

Calgary, T2N 4N2, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, B3H 1V7, Canada

Location

CIUSSS de L'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont

Montreal, H1T 2M4, Canada

Location

McGill University Health Centre

Montreal, H4A 3J1, Canada

Location

Sunnybrook Research Institute

Toronto, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, M5G 2M9, Canada

Location

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Odense University Hospital

Odense C, 5000, Denmark

Location

CHU d'Angers

Angers, 49933, France

Location

CHU de Caen

Caen, 14033, France

Location

CHRU Lille - Hospital Claude Huriez

Lille, 59037, France

Location

CHU Limoges

Limoges, 87042, France

Location

Central Hospital Lyon Sud

Lyon, 69495, France

Location

Institut Paoli Calmettes

Marseille, 13009, France

Location

CHU de Nantes, Hotel Dieu

Nantes, 44093, France

Location

CHU Nice - Hopital Archet 1

Nice, 6200, France

Location

Gustave Roussy

Paris, 94805, France

Location

Hopital Haut-Leveque

Pessac, 33604, France

Location

IUCT Oncopole

Toulouse, 31059, France

Location

Hopitaux de Brabois

Vandœuvre-lès-Nancy, France

Location

Uniklinik RWTH Aachen, Medizinische Klunuk IV - Klinik fur Hamatologie, Onkologie, Hamastaseologie und Srammzelltransplantation

Aachen, 52074, Germany

Location

Dept. of Hematology, Oncology and Tumor Immunology, Charite- University Medicine Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Department of Hematology and Oncology, Braunschweig Community Hospital

Braunschweig, 38114, Germany

Location

Universitatsklinikum Koln

Cologne, 50937, Germany

Location

Universitatsklinikum Carl Gustav Carus Dresden an der Technische Universitat Dresden, Medizinische Klinik und Poliklinik 1, Bereich Hamatologie

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf -Klinik für Hämatologie, Onkologie und Klinische Immunologie

Düsseldorf, 40225, Germany

Location

Dept. of Medicine II, University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitatsklinikum Heidelberg, Innere Medizin V, Hamatologie, Onkologie und Rheumatologie

Heidelberg, 69120, Germany

Location

Universitatsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Klinikum Ludwigshafen Medizinische Klinik A

Ludwigshafen, 67063, Germany

Location

LMU - Klinikum der Universitat Munchen, Medizinische Klinik und Poliklinik III, Campus Grosshadern

München, 81377, Germany

Location

Klinikum rechts der Isar der Technischen Universitat Munchen, Klinik und Poliklinik fur Innere Medizin III

München, 81675, Germany

Location

Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Innere Medizin III

Ulm, 89081, Germany

Location

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Azienda Ospedaliero Universitaria delle Marche

Ancona, I-60126, Italy

Location

AOU Consorziale Policlinico Bari

Bari, 70124, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malphigi U.O Ematologia

Bologna, 40138, Italy

Location

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRS - Oncologia Medica

Meldola, 40174, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli U.O.S.C. di Ematologia con Trapianto di Midollo Osseo

Napoli, 80131, Italy

Location

SC Ematologia, Azienda Ospedaliera di Perugia - Santa Maria della Misericordia

Perugia, 06129, Italy

Location

AORM - AO Riuniti Marche Norde - Pesaro Presidio "San Salvatore" - Muraglia

Pesaro, 61122, Italy

Location

Fondazione PTV Policinico Tor Vergata

Roma, 00133, Italy

Location

SCDU Ematologia e Terrapie cellulari AO O Ordine Mauriziano Torino

Torino, 10122, Italy

Location

ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Hyogo Prefectural Amagasaki General Medical Center

Amagasaki, 660-8550, Japan

Location

Chiba Aoba Municipal Hospital

Chiba, 260-0852, Japan

Location

University of Yamanashi Hospital

Chūō, 409-3898, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Aiiku Hospital

Hokkaido, 064-0804, Japan

Location

Tokai University School of Medicine

Isehara, 259-1193, Japan

Location

Kanazawa University Hospital

Kanazawa, 920-8641, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

Location

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu-shi, 807-8555, Japan

Location

Kobe City Medical Center General Hospital

Kobe, 650-0047, Japan

Location

Gunmaken Saiseikai Maebashi Hospital

Maebashi, 371-0821, Japan

Location

Ehime Prefectural Center Hospital

Matsuyama, 790-0024, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

Nagoya, 453-8511, Japan

Location

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, 466-8650, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

Location

Kindai University Hospital

Sayama, 589-8511, Japan

Location

National University Corporation Tohoku University Tohoku University Hospital

Sendai, 980-8574, Japan

Location

NTT Medical Center Tokyo

Shinagawa-Ku, 141-8625, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

University of Fukui Hospital

Yoshida-gun, 910-1193, Japan

Location

Hospital General Universitario de Alicante

Alicante, 3010, Spain

Location

Hospital del la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Institut Catala d'Oncologia

Barcelona, 08907, Spain

Location

Complejo Asistencial Universitario de Burgos/H.U. de Burgos

Burgos, 09006, Spain

Location

Complejo Hospitalario San Pedro de Alcantara

Cáceres, 10001, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

MD Anderson Cancer Center Madrid

Madrid, 28033, Spain

Location

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Clinica Universidad de Navarra - Pamplona (Main Site)

Pamplona, 31008, Spain

Location

Complejo Asistencial Universitario de Salamanca - Hsopital Clinico

Salamanca, 37007, Spain

Location

Hospital U. Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari I Politècnic La Fe

Valencia, 46026, Spain

Location

Universitetssjukhus, Hematologimottagnungen

Lund, 221 85, Sweden

Location

Universitatsspital Basel - Klinik fur Hamatrologie, Bereich Innere Medizin

Basel, 4031, Switzerland

Location

Inselspital, Universitatsspital Bern - Universitatsklinik fur Medizinisch Onkologie

Bern, CH 3010, Switzerland

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

Location

United Lincolnshire Hospitals NHS Trust, Pilgrim Hospital, Sibsey Road

Boston, PE21 9QS, United Kingdom

Location

Cambridge University Hospital NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Cardiff and Vale University Health Board

Cardiff Wales, CF14 4XW, United Kingdom

Location

Barts Health NHS Trust

City of London, EC1A 7BE, United Kingdom

Location

NHS Tayside

Dundee, DD1 9SY, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

King's College NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Oxford University Hospital NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

The Christie NHS Foundation Trust

Withington, M20 4BX, United Kingdom

Location

Related Publications (2)

• Zeidner JF, Sallman DA, Recher C, Daver NG, Leung AYH, Hiwase DK, Subklewe M, Pabst T, Montesinos P, Larson RA, Wilde L, Enjeti AK, Kawashima I, Papayannidis C, O'Nions J, Johnson L, Dong M, Huang J, Bagheri T, Hacohen Kleiman G, Lee C, Vyas P. Magrolimab plus azacitidine vs physician's choice for untreated TP53-mutated acute myeloid leukemia: the ENHANCE-2 study. Blood. 2025 Jul 31;146(5):590-600. doi: 10.1182/blood.2024027408.

  PMID: 40009500 DERIVED

• Daver NG, Vyas P, Kambhampati S, Al Malki MM, Larson RA, Asch AS, Mannis G, Chai-Ho W, Tanaka TN, Bradley TJ, Jeyakumar D, Wang ES, Sweet K, Kantarjian HM, Garcia-Manero G, Komrokji R, Xing G, Ramsingh G, Renard C, Zeidner JF, Sallman DA. Tolerability and Efficacy of the Anticluster of Differentiation 47 Antibody Magrolimab Combined With Azacitidine in Patients With Previously Untreated AML: Phase Ib Results. J Clin Oncol. 2023 Nov 1;41(31):4893-4904. doi: 10.1200/JCO.22.02604. Epub 2023 Sep 13.

  PMID: 37703506 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

magrolimab; venetoclax; Azacitidine; Cytarabine; Daunorubicin; Idarubicin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Arabinonucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 3, 2021
• Study Start: July 1, 2021
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (10); CH (2); GB (12); CA (6); FR (12); DE (13); BE (6); DK (2); US (36); JP (23); AU (10); SE (1); HK (2); ES (19)