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Compares treatment options for Acute Myeloid Leukemia
Official title Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
ClinicalTrials.gov ID: NCT05554393
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as 5 AZC, 5-AC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59
You may be able to join if
- Patient must have enrolled onto MYELOMATCH and must have been given a treatment assignment to MyeloMATCH to MM1YA-CTG01 based on the presence of an...
- Participants must have been registered to master screening and re-assessment protocol (myeloMATCH MSRP) prior to consenting to this study...
- Note: Pre-enrollment/diagnosis labs must have already been performed under the MSRP
- Previously untreated, de novo acute myeloid leukemia (AML) defined by \> 20% myeloblasts in the peripheral blood or bone marrow (refer to the 2016...
- Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11
You likely can't join if
- Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until...
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax
- Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have the potential for teratogenic or abortifacient...
- Patients with isolated myeloid sarcoma are not eligible
- Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator...
See the full eligibility criteria
Who can join
- Patient must have enrolled onto MYELOMATCH and must have been given a treatment assignment to MyeloMATCH to MM1YA-CTG01 based on the presence of an actionable mutation as defined in MYELOMATCH
- Participants must have been registered to master screening and re-assessment protocol (myeloMATCH MSRP) prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox...
- Note: Pre-enrollment/diagnosis labs must have already been performed under the MSRP
- Previously untreated, de novo acute myeloid leukemia (AML) defined by \> 20% myeloblasts in the peripheral blood or bone marrow (refer to the 2016 updated World Health Organization [WHO] classification of myeloid...
- 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 or FLT3-TKD mutations
- 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...
- Age 18-59 years at time of induction therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
- Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (must be done within 7 days of enrollment)
- Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase [SGPT]) +/or alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase [SGOT]) =\< 3 × institutional ULN (must be done within 7 days...
- Cardiac ejection fraction \>= 50% (echocardiography or multigated acquisition scan [MUGA]) (if clinically indicated must be done within 14 days of enrollment)
- Calculated creatinine clearance \>= 30 mL/min/ 1.73m\^2; Clearance to be calculated using Cockcroft formula (must be done within 7 days of enrollment)
- White blood cells (WBC) must be \< 25 x 10\^9/L. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped at least 24 hours prior...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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...
- Patient consent 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...
- Patients must be accessible for treatment, response assessment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients...
- In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment
- Participants receiving strong or moderate CYP3A inhibitors must agree to discontinue use at least 48 hours prior to start of study treatment if assigned to arm 1 or 2
- Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollment 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...
What rules you out
- Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of acute promyelocytic leukemia, if suspected, is ruled out
- Patients who are receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax
- Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events...
- Patients with isolated myeloid sarcoma are not eligible
- Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example):
- Active, uncontrolled bacterial, fungal, or viral infection
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Berkeley, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- Albany, Georgia, United States
- Boise, Idaho, United States
- Caldwell, Idaho, United States
- Coeur d'Alene, Idaho, United States
- Fruitland, Idaho, United States
- Meridian, Idaho, United States
- Nampa, Idaho, United States
- Post Falls, Idaho, United States
- Sandpoint, Idaho, United States
- Centralia, Illinois, United States
- Chicago, Illinois, United States
- Decatur, Illinois, United States
+ 128 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Berkeley, California, United States; Los Angeles, California, United States; San Francisco, California, United States and 142 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.