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Acute Myeloid LeukemiaPhase 2MAGROLICNCT05829434

Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS

A Phase 2 study testing Magrolimab, 7+3 and CPX-351 in people with Acute Myeloid Leukemia and Myelodysplastic Neoplasm, run by Uwe Platzbecker.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Use of magrolimab in combination with standard intensive chemotherapy ("7+3" or CPX-351) in newly diagnosed "ELN 2022 intermediate or adverse-risk" AML or high risk MDS patients, who intend to undergo allogeneic stem cell transplantation Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Magrolimab, 7+3 and CPX-351
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Mar 2024to 30 Aug 2029
Phase
Phase 2
Are there results?
None posted in the registry

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

  • AML or MDS-IB2 according to WHO 2022 criteria
  • For both MDS and AML: "Intermediate" or "adverse risk" genetic changes according to ELN 2022 category
  • Eligible for and intention to undergo intensive chemotherapy (IC) (CPX-351 or "7+3") followed by allogeneic HSCT, as judged by the investigator

Who cannot join

  • Patients harboring a FLT3mut, regardless of FLT3-ITD or FLT3-TKD mutation status and intended to receive midostaurin during induction and consolidation
  • Patients intended to receive gemtuzumab-ozogamicin during intensive chemotherapy
  • Patient does not accept bone marrow sampling during screening, during and after the treatment
  • Patient does not accept several blood samplings during screening, treatment and after the treatment
  • Patients who are not eligible for standard intensive chemotherapy as assessed by the treating physician
  • Previous anthracycline-containing chemotherapy (Exception: cumulative dose for 1 cycle of planned induction therapy (CPX-351 or "7+3") not reached)
Show all 39Show fewer
  • Any prior treatment for AML or MDS (except for hydroxyurea or treatment for low-risk MDS e.g. growth factors) or prior treatment with CD47 or SIRPα-targeting agents, including magrolimab
  • Inadequate organ function as defined as any criterion in the list below:
  • Congestive heart failure or documented cardiomyopathy with an EF ≤50%
  • Documented pulmonary disease with DLCO ≤65% or FEV1 ≤65%, or dyspnea at rest or requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm
  • On dialysis and age older than 60 years or uncontrolled renal carcinoma
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) > 5× upper limit of normal (ULN) or liver cirrhosis Child B or C or any biliary tree carcinoma or uncontrolled liver carcinoma or acute viral hepatitis
  • Bilirubin > 1.5× ULN, or 3.0× ULN and primarily unconjugated if patient has a documented history of Gilbert's syndrome or genetic equivalent
  • Serum creatinine > 1.5× ULN or calculated glomerular filtration rate (GFR) < 40 mL/min/1.73 m²
  • ECOG performance status of ≥ 3
  • Medical conditions other than MDS-IB-2 or AML with an estimated life expectancy below 3 months
  • Relapsed or primary refractory AML
  • Acute promyelocytic leukemia
  • Known severe cardiopulmonary disease (e.g., unstable angina, congestive heart failure with an EF ≤50%, myocardial infarction within 6 months prior to screening, symptomatic cardiomyopathy, clinically significant arrhythmia17, clinically significant pulmonary hypertension requiring pharmacologic therapy)
  • Uncontrolled high blood pressure (i.e., systolic blood pressure > 180 mm Hg, diastolic blood pressure > 95 mm Hg)18
  • Known prolonged rate-corrected QT interval ≥ 500 msec, calculated according to Fridericia's formula
  • Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Known active Human Immunodeficiency Virus infection (HIV 1/2 antibodies) with detectable viral load
  • Known active Hepatitis B (i.e., HBsAg reactive) or Hepatitis C (i.e., HCV RNA [qualitative] is detected).
  • Major surgery within 14 days of registration or a scheduled surgery during study period, depending on investigator decision
  • Known uncontrolled central nervous system (CNS) involvement of MDS-IB-2 or AML (assessment by lumbar puncture is not mandatory for screening)
  • Diagnosis or treatment for another malignancy within 1 year before registration and currently not in complete remission
  • Any evidence of residual disease of another malignancy
  • Patients with uncontrolled coagulopathy or bleeding disorder
  • History or current evidence of any condition, therapy, or laboratory abnormality that might the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Current or planned pregnancy or nursing women (negative urine or serum pregnancy test within 3 days prior to receiving study treatment is needed. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test must be performed.)
  • Female patients of childbearing potential, who are not using or not willing to use one highly effective method and one additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • Female patients who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s).
  • Male patients, who do not agree to use an adequate method of contraception, starting with the first dose of study therapy during the entire study treatment period and through 3 months after the last dose of study drug. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • Male patients who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s).
  • Age under 18 years at registration
  • Subject is unable to understand the nature, scope, significance and consequences of this clinical trial or has no legal capacity
  • Simultaneous participation in another interventional clinical trial or participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to MAGROLIC trial registration

About this study

Official title: Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed "ELN 2022 Intermediate or Adverse-risk" AML or High Risk MDS Patients Intended to Undergo Allogeneic Stem Cell Transplantation, a Phase 2, Single-arm, Open-Label Study

Use of magrolimab in combination with standard intensive chemotherapy ("7+3" or CPX-351) in newly diagnosed "ELN 2022 intermediate or adverse-risk" AML or high risk MDS patients, who intend to undergo allogeneic stem cell transplantation

Read the detailed description

Patients will receive magrolimab in combination with "7+3" or CPX-351 at:

  • Day 1, 4: IV 1 mg/kg
  • Day 8: IV 15 mg/kg
  • Day 11, 15 and 22: IV 30 mg/kg
  • Followed by weekly doses for 5 weeks and then q2w until the end of consolidation

If "7+3":

  • Induction cycle 1 (IND 1):
  • Cytarabine at 100 mg/m² on study days 1-7 as a continuous infusion over 22-24 hours
  • Daunorubicin at 60 mg/m² on study days 3, 4, 5
  • Induction cycle 2 (IND 2, optional):
  • Cytarabine at 100 mg/m² on days 1-7 of the second induction cycle (i.e. study days 29-35) as a continuous infusion over 22-24 hours
  • Daunorubicin at 60 mg/m² on days 3, 4, 5 of the second induction cycle (i.e. study days 31, 32, 33)
  • Consolidation cycle (CONS, optional):
  • Cytarabine at 1 g/m² administered on days 1, 3, 5 of each consolidation cycle as an infusion for 2 hours every 12 hours (for patients < 60 years up to 3 CONS cycles and for patients ≥ 60 years up to 2 CONS cycles)

If CPX-351:

  • Induction cycle 1 (IND 1): CPX-351 (fixed combination daunorubicin 44 mg/m² and cytarabine 100 mg/m²) days 1, 3, 5
  • Induction cycle 2 (IND 2, optional): CPX-351 (fixed combination daunorubicin 44 mg/m² and cytarabine 100 mg/m²) days 1, 3 (i.e. study days 29, 30)
  • Consolidation cycle 1 (CONS, optional): CPX-351 (fixed combination daunorubicin 29 mg/m² and cytarabine 65 mg/m²) days 1, 3
Being tested
Magrolimab, 7+3, CPX-351
Keywords
AML, Hihg-risk MDS
Medical subject headings
Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts

What participants receive

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

  • MagrolimabDrug

    Also called Hu5F9-G4, GS-4721

    Patients will receive magrolimab on day 1; 4: IV 1 mg/kg; day 8: IV 15 mg/kg; day 11, 15 and 22: IV 30 mg/kg (plus 30 mg/kg for 5 weeks weekly and then q2w until the end of consolidation)

  • 7+3Drug

    Also called Daunorubicine and Cytarabine

    Patients will receive during Induction cycle 1: cytarabine at 100 mg/m² on study days 1-7 as a continuous infusion over 22-24 hours and daunorubicin at 60 mg/m² on study days 3, 4, 5

    • optional during Induction cycle 2: cytarabine at 100 mg/m² on days 1-7 of the second induction cycle (i.e. study days 29-35) as a continuous infusion over 22-24 hours and daunorubicin at 60 mg/m² on days 3, 4, 5 of the second induction cycle (i.e. study days 31, 32, 33)
    • optional during Consolidation cycle: cytarabine at 1 g/m² administered on days 1, 3, 5 of each consolidation cycle as an infusion for 2 hours every 12 hours (for patients < 60 years up to 3 CONS cycles and for patients ≥ 60 years up to 2 CONS cycles)

  • CPX-351Drug

    Also called Vyxeos®

    Patients will receive during Induction cycle 1: CPX-351 with daunorubicin 44 mg/m² and cytarabine 100 mg/m² on days 1, 3, 5

    • optional during Induction cycle 2: CPX-351 with daunorubicin 44 mg/m² and cytarabine 100 mg/m² on days 29 + 30
    • optional during Consolidation cycle: CPX-351 with daunorubicin 29 mg/m² and cytarabine 65 mg/m² on days 1, 3
Study groups in NCT05829434
Study groupRoleWhat they receive
Magrolimab + intensive chemotherapy (7+3)ExperimentalPatients will receive magrolimab in combination with "7+3"
Receives: Drug: Magrolimab; Drug: 7+3
Magrolimab + intensive chemotherapy (CPX-351)ExperimentalPatients will receive magrolimab in combination with CPX-351
Receives: Drug: Magrolimab; Drug: CPX-351

What is being measured

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

  1. Best CR/CRi/CRh

    Analysis of best CR/CRi/CRh (taken into count: number of neutrophils, platelets and bone marrow blasts) to describe efficacy of magrolimab in combination with intensive chemotherapy

    Measured: Up to 28 days

Secondary outcomes (7)

  1. Overall Survival

    Analysis of overall survival, OS (Time from study inclusion until death from any cause)

    Measured: up to 28 months

  2. Event Free Survival

    Analysis of event free survival, EFS (Time from study inclusion until end of induction (after up to two induction chemotherapies), hematological relapse or death from any cause (whichever comes first))

    Measured: up to 57 days

  3. Relapse Free Survival

    Analysis of relapse free survival, RFS (only for patients achieving CR); Time from achievement of complete remission until hematological relapse or death from any cause (whichever comes first)

    Measured: up to 28 months

  4. Rate of allo HSCT

    Rate of allogeneic hematopoietic stem cell transplantation, After induction cycle

    Measured: up to 28 days

  5. Quality of life (EORTC QLQ-C30)

    Evaluation according to EORTC QLQ-C30 Scoring Manual, Registration, during treatment and end of treatment

    To assess patient-reported quality of life during magrolimab treatment: 30 questions assessing the quality of life of oncology patients across 10 subscales will be analyzed. All subscales have a score range from 0 to 100 points.

    Function subscales: a higher score represents a higher quality of life. Symptoms subscales: higher score represents higher level of symptoms/problems, i.e., represents lower quality of life.

    Measured: up to 4 months

  6. Quality of life (EQ-5D-5L)

    Evaluation according to EQ-5D-5L User Guide, Registration, during treatment and end of treatment

    To assess patient-reported quality of life during magrolimab treatment within five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

    Level 1 is coded as a '1', Level 2 is coded as a '2' and so on. Higher levels indicate lower quality of life..

    Measured: up to 4 months

  7. Rate and severity of adverse events

    Rate and severity of adverse events for patients treated with magrolimab and induction chemotherapy (Start of treatment up to end of treatment)

    Measured: up to 4 months

Timeline

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

  1. First posted25 Apr 2023
  2. Study start31 Mar 2024 (estimated)
  3. Primary completion30 Aug 2028 (estimated)
  4. Study completion30 Aug 2029 (estimated)

Why it stopped: Trial was stopped prematurely due to safety reasons

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients are either treated with CPX-351 or 7+3
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05829434
Sponsor's protocol ID
MAGROLIC
Other IDs
EU Trial Number
Acronym
MAGROLIC
Status last verified
Feb 2024
First submitted
22 Mar 2023
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Magrolimab, 7+3 and CPX-351 in people with Acute Myeloid Leukemia and Myelodysplastic Neoplasm, run by Uwe Platzbecker.

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 3 inclusion and 39 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: withdrawn, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Best CR/CRi/CRh (time frame: Up to 28 days). 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 NCT05829434.

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 12 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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