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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04778397




Registration number
NCT04778397
Ethics application status
Date submitted
23/02/2021
Date registered
3/03/2021
Date last updated
15/04/2024

Titles & IDs
Public title
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
Scientific title
A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia
Secondary ID [1] 0 0
2020-003949-11
Secondary ID [2] 0 0
GS-US-546-5857
Universal Trial Number (UTN)
Trial acronym
ENHANCE-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Magrolimab
Treatment: Drugs - Venetoclax
Treatment: Drugs - Azacitidine
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin
Treatment: Drugs - Idarubicin
Treatment: Drugs - Steroidal Eye Drops

Experimental: Magrolimab + Azacitidine - Participants will receive an escalating dose of magrolimab and a fixed dose of azacitidine.

Active Comparator: Control Arm: Venetoclax + Azacitidine - Participants who are appropriate for non-intensive therapy will receive an escalating dose of venetoclax and a fixed dose of azacitidine.

Active Comparator: Control Arm: 7+3 Chemotherapy - 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.


Treatment: Drugs: Magrolimab
Administered intravenously (IV).

Treatment: Drugs: Venetoclax
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).

Treatment: Drugs: Azacitidine
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).

Treatment: Drugs: Cytarabine
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.

Treatment: Drugs: Daunorubicin
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).

Treatment: Drugs: Idarubicin
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).

Treatment: Drugs: Steroidal Eye Drops
Administered per institutional standard during consolidation.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy
Timepoint [1] 0 0
Randomization up to death or end of study (up to 27 months) whichever occurs first
Secondary outcome [1] 0 0
Overall Survival in All Participants
Timepoint [1] 0 0
Randomization up to death or end of study (up to 27 months) whichever occurs first
Secondary outcome [2] 0 0
Event-Free Survival (EFS) in All Participants
Timepoint [2] 0 0
Randomization up to end of study (up to 27 months)
Secondary outcome [3] 0 0
Rate of Complete Remission (CR) in All Participants
Timepoint [3] 0 0
6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy
Secondary outcome [4] 0 0
Rate of CR Without Minimal Residual Disease (CR MRD-) in All Participants
Timepoint [4] 0 0
6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy
Secondary outcome [5] 0 0
Rate of CR and Complete Remission with Partial Hematologic Recovery (CR+CRh) in All Participants
Timepoint [5] 0 0
6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy
Secondary outcome [6] 0 0
Duration of Complete Remission (DCR)
Timepoint [6] 0 0
First CR achieved within 6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy up to the end of study (up to 27 months)
Secondary outcome [7] 0 0
Duration of CR+CRh
Timepoint [7] 0 0
First CR or CRh achieved within 6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy up to the end of study (up to 27 months)
Secondary outcome [8] 0 0
Percentage of Participants Experiencing Grade = 3 Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Timepoint [8] 0 0
First dose date up to last dose date (Maximum: 24 months) plus 70 days
Secondary outcome [9] 0 0
Percentage of Participants Experiencing Grade = 3 Treatment-Emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0
Timepoint [9] 0 0
First dose date up to last dose date (Maximum: 24 months) plus 70 days
Secondary outcome [10] 0 0
Serum Concentration of Magrolimab
Timepoint [10] 0 0
Within 72 hours predose on Day 1 of Cycle 1, within 12 hours predose on Day 8 of Cycle 1 and Day 1 of Cycles 2, 3, 5, 7, 10, 13, and end of treatment (EOT) EOT=Maximum: 24 months (Cycle=28 days)
Secondary outcome [11] 0 0
Rate of Anti-Magrolimab Antibody Incidence
Timepoint [11] 0 0
Within 72 hours predose on Day 1 of Cycle 1, within 12 hours predose on Day 1 of Cycles 2, 3, 5, 7, 10, 13 and end of treatment (EOT) EOT=Maximum: 24 months (Cycle=28 days)

Eligibility
Key inclusion criteria
Key

- 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.

- Pretreatment blood cross-match completed.

- Males and females of childbearing potential who engage in heterosexual intercourse
must agree to use protocol-specified method(s) of contraception.

- Individuals must be willing to consent to mandatory pretreatment and on-treatment bone
marrow biopsies (aspirate and trephines).

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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
(SIRPa)-targeting agents

- Antileukemic therapy for the treatment of AML (excluding hydroxyurea),
hypomethylating agent (HMA), low dose cytarabine and/or venetoclax.

Note: Individuals with prior myelodysplastic syndrome (MDS) who have not received prior
HMAs or chemotherapeutic agents for MDS are allowed on study. Other prior MDS therapies
including, but not limited to, lenalidomide, erythroid stimulating agents, or similar
RBC-direct therapies, are allowed. Localized non-central nervous system (CNS) radiotherapy,
erythroid and/or myeloid growth factors, hormonal therapy with luteinizing
hormone-releasing hormone agonists for prostate cancer, hormonal therapy or maintenance for
breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor
kappa-B ligand inhibitors are also not criteria for exclusion.

- 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.

- Individuals who have acute promyelocytic leukemia.

- Significant disease or medical conditions, as assessed by the investigator and
sponsor, that would substantially increase the risk-benefit ratio of participating in
the study. This includes, but is not limited to, acute myocardial infarction within
the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active
infections, and congestive heart failure New York Heart Association Class III-IV.

- Second malignancy, except MDS, treated basal cell or localized squamous skin
carcinomas, localized prostate cancer, or other malignancies for which individuals are
not on active anti-cancer therapies and have had no evidence of active malignancy for
at least = 1 year Note: Individuals on maintenance therapy alone who have no evidence
of active malignancy for at least = 1 year are eligible.

- Known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
or human immunodeficiency virus (HIV) infection in medical history.

- Active HBV, and/or active HCV, and/or HIV following testing at screening:

- Individuals who test positive for hepatitis B surface antigen (HBsAg).
Individuals who test positive for hepatitis B core antibody (anti-HBc) will
require HBV deoxyribose nucleic acid (DNA) by quantitative polymerase chain
reaction (PCR) for confirmation of active disease.

- Individuals who test positive for HCV antibody. These individuals will require
HCV ribose nucleic acid (RNA) quantitative PCR for confirmation of active
disease.

- Individuals who test positive for HIV antibody.

- Individuals not currently receiving antiviral therapy and who have an
undetectable viral load in the prior 3 months may be eligible for the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/03/2024
Sample size
Target
Accrual to date
Final
258
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Calvary Master Newcastle - Waratah
Recruitment hospital [3] 0 0
Westmead Hospital / Department of Haematology and Bone Marrow Transplantation - Westmead
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Andrew Love Cancer Centre, University Hospital Geelong - Geelong
Recruitment hospital [7] 0 0
The Alfred - Melbourne
Recruitment hospital [8] 0 0
St Vincents Hospital Melbourne - Melbourne
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3122 - Melbourne
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment outside Australia
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Alabama
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Ulm
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Maebashi
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Nagasaki
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Nagoya
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Okayama-Shi
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Osaka-Shi
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Sendai
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Alicante
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Barcelona
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Burgos
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Cordoba
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Cáceres
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Malaga
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Oviedo
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Pamplona
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Salamanca
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Santander
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Spain
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Valencia
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Sweden
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Lund
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Switzerland
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Basel
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Switzerland
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Berne
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Birmingham
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Boston
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Cambridge
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United Kingdom
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Cardiff Wales
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United Kingdom
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City of London
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United Kingdom
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Dundee
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Oxford
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United Kingdom
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Sutton
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United Kingdom
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Withington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04778397
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04778397