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Acute Myeloid LeukemiaPhase 2NCT05554419

Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Treatment, The ERASE Study (A MyeloMATCH Treatment Trial)

A Phase 2 study testing Azacitidine, Bone Marrow Aspiration and Biopsy and Cytarabine in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, run by National Cancer Institute (NCI).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This phase II MyeloMATCH treatment trial compares cytarabine versus (vs.) cytarabine and venetoclax vs. liposome-encapsulated daunorubicin-cytarabine and venetoclax vs. azacitidine and venetoclax for treating patients who have residual disease after treatment for acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 18 to 59 years
What is being tested?
Azacitidine, Bone Marrow Aspiration and Biopsy and Cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
No sites listed yet
Study dates
4 Jan 2027to 31 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patient must be >= 18 and =< 59 years of age
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patient must have morphologically documented AML or secondary AML (from prior conditions such as myelodysplastic syndrome [MDS], myeloproliferative neoplasm [MPN]) or therapy related AML (t-AML), as defined by World Health Organization (WHO) criteria
  • Patient must have completed induction chemotherapy in a myeloMATCH young adult tier-1 protocol. Patient may have received prior hypomethylating agents (HMAs). Patient may have received prior azacitidine + venetoclax
  • Patient must have been assigned to this protocol by myeloMATCH master screening and reassessment protocol (MSRP)/MATCHBOX. Patients thereby assigned will have attained complete remission (CR) or CR with partial hematologic recovery (CRh) (defined as CR with [absolute neutrophil count (ANC)] >= 500/mcL and/or platelets > 50/mcL) with detectable MRD at time of assignment. MRD is defined as > 0.1% flow cytometry on bone marrow (BM) biopsy as assessed by MDNet. The definition of CR or CRh may be made +/- 2 weeks from BM biopsy
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
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  • Patient must have recovered (i.e.: resolved to < grade 2) from adverse events related to prior anti-cancer therapy at the time of randomization with the exception of alopecia
  • Absolute neutrophil count (ANC) >= 500/mcL (obtained =< 7 days prior to protocol randomization)
  • Platelets >= 50,000/mcL (obtained =< 7 days prior to protocol randomization)
  • Total bilirubin =< 2 x institutional upper limit of normal (ULN) (obtained =< 7 days prior to protocol randomization)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN (obtained =< 7 days prior to protocol randomization)
  • Creatinine =< 1.5 x institutional ULN OR >= 50 mL/min.1.73 m^2 (obtained =< 7 days prior to protocol randomization)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Patients must be able to swallow oral tablets and be free of gastrointestinal (GI) absorption issues

Who cannot join

  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
  • All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.
  • A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patients of childbearing potential and/or sexually active patients must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and continue for 6 months after the last dose of daunorubicin + cytarabine liposome, 6 months after the last dose of azacitidine for patients of childbearing potential, 3 months after the last dose of azacitidine for male patients, and for 30 days after the last dose of venetoclax. Patient must also abstain from nursing an infant for 2 weeks after the last dose of daunorubicin + cytarabine liposome and for 1 week after the last dose of azacitidine
  • Patients must not have FLT3 TKD or ITD mutation. Patients with this mutation, will be excluded from this study because myeloMATCH plans separate studies in tier-2 for those patients
  • Patient must not be receiving any other investigational agents at the time of randomization
  • Patient must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, azacitidine, venetoclax or daunorubicin and cytarabine liposome
  • Patients must not have uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or serious chronic gastrointestinal conditions associated with diarrhea

About this study

Official title: Eradicating Measurable Residual Disease in Patients With Acute Myeloid Leukemia (AML) Prior to StEm Cell Transplantation (ERASE): A MyeloMATCH Treatment Trial

This phase II MyeloMATCH treatment trial compares cytarabine versus (vs.) cytarabine and venetoclax vs. liposome-encapsulated daunorubicin-cytarabine and venetoclax vs. azacitidine and venetoclax for treating patients who have residual disease after treatment for acute myeloid leukemia (AML). Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Liposome-encapsulated daunorubicin-cytarabine is a drug formulation that delivers daunorubicin and cytarabine in small spheres called liposomes, which may make the drugs safer or more effective. Azacitidine is a drug that interacts with DNA and leads to the activation of tumor suppressor genes, which are genes that help control cell growth. This study may help the study doctors find out if the different drug combinations are equally effective to the usual approach of cytarabine alone while requiring a shorter duration of treatment. To decide if they are better, the study doctors will be looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to cytarabine alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To improve the rate of measurable residual disease (MRD) negative complete remission (CR) in patients with acute myeloid leukemia (AML) who have achieved a MRD positive CR after induction chemotherapy received in a myeloMATCH young adult basket tier-1 protocol.

II. To determine the rate of achieving MRD negative CR after 2 cycles of post-remission therapy with cytarabine vs. cytarabine + venetoclax or liposome-encapsulated daunorubicin-cytarabine (daunorubicin and cytarabine liposome) + venetoclax azacitidine + venetoclax in AML or myelodysplastic syndrome (MDS) who were MRD positive post induction therapy.

SECONDARY OBJECTIVES:

  1. To determine the disease-free survival, overall survival in this group of patients.

II. Assess the percentage of patients who receive allogeneic hematopoietic stem cell transplantation (HCT).

III. Compare toxicities of each experimental arm with the control arm.

EXPLORATORY OBJECTIVES:

  1. Evaluate MRD kinetics by following patients with detectable MRD through tier 2 and beyond.

II. Evaluate longer term outcomes by treatment arm, genomics, MRD outcome, and other features as patients receive additional myeloMATCH therapies to generate testable hypotheses for more precise patient selection for these therapies aimed at improving outcomes.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM A: Patients receive cytarabine intravenously (IV) on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo echocardiogram (ECHO) and/or multigated acquisition scan (MUGA) as clinically indicated.

ARM B: Patients receive cytarabine IV and venetoclax orally (PO) on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

ARM C: Patients receive liposome-encapsulated daunorubicin-cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

ARM D: Patients receive azacitidine IV or subcutaneously (SC) and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

Being tested
Azacitidine, Bone Marrow Aspiration and Biopsy, Cytarabine, Echocardiography Test, Liposome-encapsulated Daunorubicin-Cytarabine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

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

  • AzacitidineDrug

    Also called 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine

    Given IV or SC

  • Bone Marrow Aspiration and BiopsyProcedure or surgery

    Undergo bone marrow aspiration and biopsy

  • CytarabineDrug

    Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone

    Given IV

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • Liposome-encapsulated Daunorubicin-CytarabineDrug

    Also called CPX 351, CPX-351, CPX351, Cytarabine and Daunorubicin Liposomal

    Given IV

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • VenetoclaxDrug

    Also called ABT 199, ABT-0199, ABT-199, ABT199

    Given PO

Study groups in NCT05554419
Study groupRoleWhat they receive
ARM A (cytarabine)Active comparatorPatients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Receives: Procedure: Bone Marrow Aspiration and Biopsy; Drug: Cytarabine; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan
ARM B (cytarabine, venetoclax)ExperimentalPatients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Receives: Procedure: Bone Marrow Aspiration and Biopsy; Drug: Cytarabine; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Drug: Venetoclax
ARM C (liposomal daunorubicin-cytarabine, venetoclax)ExperimentalPatients receive liposome-encapsulated daunorubicin-cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Receives: Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Echocardiography Test; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Procedure: Multigated Acquisition Scan; Drug: Venetoclax
ARM D (azacitidine, venetoclax)ExperimentalPatients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.
Receives: Drug: Azacitidine; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Drug: Venetoclax

What is being measured

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

  1. Frequency of measurable residual disease (MRD) negative complete remission (CR)

    Will be centrally evaluated. The MRD negative CR frequency will be compared between each experimental arm and the standard therapy arm using Fisher's exact test with one-sided alpha of 0.10 for each comparison. Test results with one-sided p-value < 0.10 will be considered statistically significant. Multivariable logistic regression modeling will also be used to examine the treatment effect between each experimental arm and the standard therapy arm, adjusting for stratification factors and other possible clinical and biological risk factors.

    Measured: Following 2 cycles of consolidation (56 days)

Secondary outcomes (4)

  1. Overall survival

    Estimates, including medians and confidence intervals, will be calculated using the Kaplan-Meier method. Comparison between each experimental arm and the standard therapy arm will be conducted using the one-sided log-rank test. Only nominal p-values will be provided. Cox proportional hazards models will also be used to assess the treatment effect, adjusting for stratification factors and other possible clinical and biological risk factors.

    Measured: Between randomization and death from any cause, assessed up to 10 years

  2. Disease-free survival

    Estimates, including medians and confidence intervals, will be calculated using the Kaplan-Meier method. Comparison between each experimental arm and the standard therapy arm will be conducted using the one-sided log-rank test. Only nominal p-values will be provided. Cox proportional hazards models will also be used to assess the treatment effect, adjusting for stratification factors and other possible clinical and biological risk factors.

    Measured: From randomization to relapse or death in remission, assessed up to 10 years

  3. Rate of allogeneic transplant

    Measured: Up to 10 years

  4. Incidence of adverse events

    Toxicity will be determined using the Common Terminology Criteria for Adverse Events (CTCAE).

    Measured: Up to 10 years

Timeline

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

  1. First posted26 Sep 2022
  2. Study start4 Jan 2027 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05554419
Sponsor's protocol ID
NCI-2022-07799
Other IDs
NCI-2022-07799, MM2YA-EA01, MM2YA-EA01, U10CA180820
Status last verified
Sep 2026
First submitted
23 Sep 2022
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azacitidine, Bone Marrow Aspiration and Biopsy and Cytarabine in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, run by National Cancer Institute (NCI).

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 18 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Frequency of measurable residual disease (MRD) negative complete remission (CR) (time frame: Following 2 cycles of consolidation (56 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 NCT05554419.

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 1 Oct 2026.

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Clinical Trial NCT05554419 | AzTrials