Comparing 3 approaches for acute myeloid leukemia

Inclusion

• +Age 18-59 years at time of induction therapy
• +Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → are eligible for this trial
• +Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days of enrollment. Patients need to be on suppressive therapy, if indicated
• +Patients with a history of hepatitis C virus (HCV) infection who have been treated and cured are eligible. Patients who with active HCV infection who are currently being treated must have an undetectable HCV viral load within 28 days of enrollment to be eligible
• +Participants must have been registered to master screeningScreeningThe checks done before joining, to see whether a study fits.Read more → and re-assessment protocolProtocolThe detailed plan a study must follow.Read more → (MYELOMATCH) prior to consenting to this study. Participants must have been assigned to this clinical trialInterventional studyA study where participants are given something to see what happens.Read more →, via MATCHBox Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine and must be offered the opportunity to submit biosamples for banking for future research as per MYELOMATCH
• +Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
• +Previously untreated, de novo acute myeloid leukemia (AML) defined by \>= 20% myeloblasts in the peripheral blood or bone marrow (as defined by the current World Health Organization \[WHO\] classification of myeloid neoplasms and acute leukemia) excluding all the following categories of AML:
• +Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11
• +CEBPA biallelic mutations
• +NPM1 mutation
• +AML with PML-RARalpha
• +AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23/KMT2 rearrangements
• +AML with FLT3-ITD mutation
• +Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
• +Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (must be done within 10 days of enrollment)
• +Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase \[SGPT\]) and/or alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase \[SGOT\]) =\< 3 × institutional ULN (must be done within 10 days of enrollment)
• +Cardiac ejection fraction \>= 50% (echocardiography or MUGA) (if clinically indicated must be done within 14 days of enrollment)
• +Calculated creatinine clearance \>= 30 mL/min; Clearance to be calculated using Cockcroft formula (must be done within 10 days of enrollment)
• +White blood cells (WBC) must be =\< 25 x 10\^9/L. Hydroxyurea and leukapheresis are permitted to controlControl groupThe group a new treatment is measured against.Read more → the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to the initiation of protocol therapy. Hydroxyurea +/- no more than a total of 2500 mg cytarabine over a total of multiple days for urgent cytoreduction is also permitted
• +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
• +Patient consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
• +Patients must be accessible for treatment, response assessment and follow upFollow-upContinued check-ins after the treatment part is finished.Read more →. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →, and follow-up.
• +Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial
• +In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment
• +Women of childbearing potential will have a pregnancy test to determine eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. Patient will be considered eligible if an ultrasound is negative for pregnancy
• +Therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease
• +Males and females of reproductive potential must have agreed to use a highly effective contraceptive method while on treatment and for 6 months after stopping study drug. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.