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Leukemia, Myeloid, AcutePhase 2ERASENCT05628623

Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia (AML) Following Initial Treatment

A Phase 2 study testing Cytarabine, Venetoclax and CPX-351 in people with Leukemia, Myeloid, Acute, run by Eastern Cooperative Oncology Group.

Not yet recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

ERASE is part of the MyeloMATCH initiative, Young Adult Basket and is a Tier 2 study. The study is comparing the use of Cytarabine to Cytarabine and Venetoclax, Daunorubicin/Cytarabine Liposome and Venetoclax, and Azacitidine and Venetoclax. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
Cytarabine, Venetoclax and CPX-351
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
No sites listed yet
Study dates
23 Oct 2024to Feb 2027
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 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 MSRP/MATCHBOX/. Patients thereby assigned will have attained complete remission (CR) or CR with partial hematologic recovery (CRh) (defined as CR with (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
  • Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 7 days prior to protocol randomization):
  • Absolute neutrophil count (ANC) ≥ 500/mcL ANC: Date of Test: Platelets ≥ 50,000/mcL Platelets: Date of Test: Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) Total Bilirubin: Institutional ULN: Date of Test: AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN AST: Institutional ULN: Date of Test: ALT: Institutional ULN: Creatinine ≤ 1.5 x institutional ULN Creatinine Date of Test: OR
  • ≥ 50 mL/min/1.73 m2
  • 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 must be able to swallow oral tablets and be free of 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).
  • Patient of child bearing potential? (Yes or No) Date of blood test or urine study:
  • 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 + cytrarabine 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 + cytrarabine 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
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  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ehab Atallah, MD contact

414-805-4600

eatallah@mcw.edu

Yasmin Abaza, MD contact

866-587-4322

yasmin.abaza@nm.org

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

ERASE is part of the MyeloMATCH initiative, Young Adult Basket and is a Tier 2 study. The study is comparing the use of Cytarabine to Cytarabine and Venetoclax, Daunorubicin/Cytarabine Liposome and Venetoclax, and Azacitidine and Venetoclax.

Read the detailed description

MM2YA-EA01 is a randomized Phase 2 study. Patients will be randomized to 1 of 4 treatment arms in a 1:1:1:1 ratio. The 4 treatment arms will compare: Cytarabine 3000 mg/m2 for CBD patients/1500 mg/m2 for non-CBD patients to cytarabine 3000 mg/m2 for CBD patients/1500 mg/m2 for non-CBD patients plus venetoclax 100 mg, daunorubicin 29 mg/m2/Cytarabine 65 mg/m2 liposome plus venetoclax 400 mg, and Azacitidine 75 mg/m2 plus venetoclax 400 mg.

Being tested
Cytarabine, Venetoclax, CPX-351, Azacitidine
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.

  • CytarabineDrug

    Also called 63878

    Arm A: CBF-Cytarabine 3000 mg/m2 or 1500 mg/m2 IV twice daily (BID), 12 hours apart x 6 doses either on Days 1, 3, and 5 OR Days 1, 2, and 3

  • VenetoclaxDrug

    Also called Venclexta, 766270

    Venetoclax 100 mg daily Day 1 through Day 8 Venetoclax 400 mg orally once daily on Days 1-14 Venetoclax 400 mg orally once daily on Days 1-28

  • CPX-351Drug

    Also called Daunorubicin + Cytarabine Liposome, Vyxeos, 775341

    Daunorubicin 29 mg/m2/Cytarabine 65 mg/m2 liposome IV on Days 1 and 3

  • AzacitidineDrug

    Also called Onureg, Vidaza, 102816

    Azacitidine 75 mg/m2 IV/SC on Days 1-7 OR Days 1-5 and Days 8-9 (per institutional preference)

Study groups in NCT05628623
Study groupRoleWhat they receive
Arm A: CytarabineActive comparatorPatients will participate for 2 cycles. Each cycle is 28 days. For Core Binding Factor (CBF) leukemia patients: Cytarabine 3000 mg/m2 IV twice daily (BID), 12 hours apart x 6 doses either on Days 1, 3, and 5 OR Days 1, 2, and 3 (per institutional preference) For non-Core Binding Factor (CBF) leukemia patients: Cytarabine 1500 mg/m2 IV twice daily (BID), 12 hours apart x 6 either on Days 1, 3, and 5 OR Days 1, 2, and 3 (per institutional preference)
Receives: Drug: Cytarabine
Arm B: Cytarabine + VenetoclaxExperimentalPatients will participate for 2 cycles. Each cycle is 28 days. For Core Binding Factor (CBF) leukemia patients: Cytarabine 3000 mg/m2 IV twice daily (BID), 12 hours apart x 6 doses either on Days 1, 3, and 5 OR Days 1, 2, and 3 (per institutional preference) followed by Venetoclax 100 mg daily Day 1 through Day 8 For non-Core Binding Factor (CBF) leukemia patients: Cytarabine 1500 mg/m2 IV twice daily (BID), 12 hours apart x 6 either on Days 1, 3, and 5 OR Days 1, 2, and 3 (per institutional preference) followed by Venetoclax 100 mg daily Day 1 through Day 8
Receives: Drug: Cytarabine; Drug: Venetoclax
Arm C: Daunorubicin + Cytarabine Liposome+ VenetoclaxExperimentalPatients will participate for 2 cycles. Each cycle is 28 days. Daunorubicin 29 mg/m2/Cytarabine 65 mg/m2 liposome IV on Days 1 and 3 with Venetoclax 400 mg orally once daily on Days 1-14
Receives: Drug: Venetoclax; Drug: CPX-351
Arm D: Azacitidine + VenetoclaxExperimentalPatients will participate for 2 cycles. Each cycle is 28 days. Azacitidine 75 mg/m2 IV/SC on Days 1-7 OR Days 1-5 and Days 8-9 (per institutional preference) with Venetoclax 400 mg orally once daily on Days 1-28
Receives: Drug: Venetoclax; Drug: Azacitidine

What is being measured

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

  1. Rate of Achieving Minimal residual disease (MRD)

    Rate of Achieving MRD Negative CR

    Measured: Day 56

Timeline

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

  1. First posted28 Nov 2022
  2. Study start23 Oct 2024 (estimated)
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2027 (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
Model description
Participants will be randomized to 1 of 4 arms in a 1:1:1:1 ratio.
Masking
None (open label)
Enrolment
184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05628623
Sponsor's protocol ID
MM2YA-EA01
Acronym
ERASE
Status last verified
Jun 2024
First submitted
18 Nov 2022
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Araki D, Wood BL, Othus M, Radich JP, Halpern AB, Zhou Y, Mielcarek M, Estey EH, Appelbaum FR, Walter RB. Allogeneic Hematopoietic Cell Transplantation for Acute Myeloid Leukemia: Time to Move Toward a Minimal Residual Disease-Based Definition of Complete Remission? J Clin Oncol. 2016 Feb 1;34(4):329-36. doi: 10.1200/JCO.2015.63.3826. Epub 2015 Dec 14.

    PubMed 26668349

  • Othus M, Wood BL, Stirewalt DL, Estey EH, Petersdorf SH, Appelbaum FR, Erba HP, Walter RB. Effect of measurable ('minimal') residual disease (MRD) information on prediction of relapse and survival in adult acute myeloid leukemia. Leukemia. 2016 Oct;30(10):2080-2083. doi: 10.1038/leu.2016.120. Epub 2016 May 2. No abstract available.

    PubMed 27133827

  • Freeman SD, Hills RK, Virgo P, Khan N, Couzens S, Dillon R, Gilkes A, Upton L, Nielsen OJ, Cavenagh JD, Jones G, Khwaja A, Cahalin P, Thomas I, Grimwade D, Burnett AK, Russell NH. Measurable Residual Disease at Induction Redefines Partial Response in Acute Myeloid Leukemia and Stratifies Outcomes in Patients at Standard Risk Without NPM1 Mutations. J Clin Oncol. 2018 May 20;36(15):1486-1497. doi: 10.1200/JCO.2017.76.3425. Epub 2018 Mar 30.

    PubMed 29601212

  • Buccisano F, Maurillo L, Gattei V, Del Poeta G, Del Principe MI, Cox MC, Panetta P, Consalvo MI, Mazzone C, Neri B, Ottaviani L, Fraboni D, Tamburini A, Lo-Coco F, Amadori S, Venditti A. The kinetics of reduction of minimal residual disease impacts on duration of response and survival of patients with acute myeloid leukemia. Leukemia. 2006 Oct;20(10):1783-9. doi: 10.1038/sj.leu.2404313. Epub 2006 Jul 13.

    PubMed 16838027

  • Freeman SD, Virgo P, Couzens S, Grimwade D, Russell N, Hills RK, Burnett AK. Prognostic relevance of treatment response measured by flow cytometric residual disease detection in older patients with acute myeloid leukemia. J Clin Oncol. 2013 Nov 10;31(32):4123-31. doi: 10.1200/JCO.2013.49.1753. Epub 2013 Sep 23.

    PubMed 24062403

  • Terwijn M, van Putten WL, Kelder A, van der Velden VH, Brooimans RA, Pabst T, Maertens J, Boeckx N, de Greef GE, Valk PJ, Preijers FW, Huijgens PC, Drager AM, Schanz U, Jongen-Lavrecic M, Biemond BJ, Passweg JR, van Gelder M, Wijermans P, Graux C, Bargetzi M, Legdeur MC, Kuball J, de Weerdt O, Chalandon Y, Hess U, Verdonck LF, Gratama JW, Oussoren YJ, Scholten WJ, Slomp J, Snel AN, Vekemans MC, Lowenberg B, Ossenkoppele GJ, Schuurhuis GJ. High prognostic impact of flow cytometric minimal residual disease detection in acute myeloid leukemia: data from the HOVON/SAKK AML 42A study. J Clin Oncol. 2013 Nov 1;31(31):3889-97. doi: 10.1200/JCO.2012.45.9628. Epub 2013 Sep 23.

    PubMed 24062400

  • Pan R, Hogdal LJ, Benito JM, Bucci D, Han L, Borthakur G, Cortes J, DeAngelo DJ, Debose L, Mu H, Dohner H, Gaidzik VI, Galinsky I, Golfman LS, Haferlach T, Harutyunyan KG, Hu J, Leverson JD, Marcucci G, Muschen M, Newman R, Park E, Ruvolo PP, Ruvolo V, Ryan J, Schindela S, Zweidler-McKay P, Stone RM, Kantarjian H, Andreeff M, Konopleva M, Letai AG. Selective BCL-2 inhibition by ABT-199 causes on-target cell death in acute myeloid leukemia. Cancer Discov. 2014 Mar;4(3):362-75. doi: 10.1158/2159-8290.CD-13-0609. Epub 2013 Dec 17.

    PubMed 24346116

  • DiNardo CD, Lachowiez CA, Takahashi K, Loghavi S, Xiao L, Kadia T, Daver N, Adeoti M, Short NJ, Sasaki K, Wang S, Borthakur G, Issa G, Maiti A, Alvarado Y, Pemmaraju N, Montalban Bravo G, Masarova L, Yilmaz M, Jain N, Andreeff M, Jabbour E, Garcia-Manero G, Kornblau S, Ravandi F, Konopleva MY, Kantarjian HM. Venetoclax Combined With FLAG-IDA Induction and Consolidation in Newly Diagnosed and Relapsed or Refractory Acute Myeloid Leukemia. J Clin Oncol. 2021 Sep 1;39(25):2768-2778. doi: 10.1200/JCO.20.03736. Epub 2021 May 27.

    PubMed 34043428

  • Kadia TM, Reville PK, Borthakur G, Yilmaz M, Kornblau S, Alvarado Y, Dinardo CD, Daver N, Jain N, Pemmaraju N, Short N, Wang SA, Tidwell RSS, Islam R, Konopleva M, Garcia-Manero G, Ravandi F, Kantarjian HM. Venetoclax plus intensive chemotherapy with cladribine, idarubicin, and cytarabine in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome: a cohort from a single-centre, single-arm, phase 2 trial. Lancet Haematol. 2021 Aug;8(8):e552-e561. doi: 10.1016/S2352-3026(21)00192-7.

    PubMed 34329576

  • Maiti A, DiNardo CD, Qiao W, Kadia TM, Jabbour EJ, Rausch CR, Daver NG, Short NJ, Borthakur G, Pemmaraju N, Yilmaz M, Alvarado Y, Montalbano KS, Wade A, Maduike RE, Guerrero JA, Vaughan K, Bivins CA, Pierce S, Ning J, Ravandi F, Kantarjian HM, Konopleva MY. Ten-day decitabine with venetoclax versus intensive chemotherapy in relapsed or refractory acute myeloid leukemia: A propensity score-matched analysis. Cancer. 2021 Nov 15;127(22):4213-4220. doi: 10.1002/cncr.33814. Epub 2021 Aug 3.

    PubMed 34343352

  • DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.

    PubMed 32786187

  • Cortes JE, Goldberg SL, Feldman EJ, Rizzeri DA, Hogge DE, Larson M, Pigneux A, Recher C, Schiller G, Warzocha K, Kantarjian H, Louie AC, Kolitz JE. Phase II, multicenter, randomized trial of CPX-351 (cytarabine:daunorubicin) liposome injection versus intensive salvage therapy in adults with first relapse AML. Cancer. 2015 Jan 15;121(2):234-42. doi: 10.1002/cncr.28974. Epub 2014 Sep 15.

    PubMed 25223583

  • Plesa A, Roumier C, Gutrin J, Larcher MV, Balsat M, Cadassou O, Barraco F, Fossard G, Baudouin A, Labussiere H, Tigaud I, Ducastelle S, Hayette S, Sujobert P, Heiblig M, Elhamri M, Thomas X. Measurable residual disease including AML leukemia stem cell flow evaluation of CPX-351 therapy by multi-parameter flow cytometry. Leuk Res. 2021 Dec;111:106673. doi: 10.1016/j.leukres.2021.106673. Epub 2021 Jul 26. No abstract available.

    PubMed 34364023

  • Kolitz JE, Strickland SA, Cortes JE, Hogge D, Lancet JE, Goldberg SL, Villa KF, Ryan RJ, Chiarella M, Louie AC, Ritchie EK, Stuart RK. Consolidation outcomes in CPX-351 versus cytarabine/daunorubicin-treated older patients with high-risk/secondary acute myeloid leukemia. Leuk Lymphoma. 2020 Mar;61(3):631-640. doi: 10.1080/10428194.2019.1688320. Epub 2019 Nov 25.

    PubMed 31760835

  • Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, Omura GA, Moore JO, McIntyre OR, Frei E 3rd. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994 Oct 6;331(14):896-903. doi: 10.1056/NEJM199410063311402.

    PubMed 8078551

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytarabine, Venetoclax and CPX-351 in people with Leukemia, Myeloid, Acute, run by Eastern Cooperative Oncology Group.

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 15 inclusion and 9 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 3 Jul 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?

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?

Contact Ehab Atallah, MD (414-805-4600, eatallah@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Achieving Minimal residual disease (MRD) (time frame: Day 56). 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 NCT05628623, which also lists 22 linked publications.

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 3 Jul 2024.

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