Trial comparing treatments 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 being studied as a potential treatment for acute myeloid leukemia. It is designed to interact with DNA to activate tumor-suppressing genes, which may help stop the growth of cancer cells.
Also referred to as Vidaza, Mylosar, 5-Azacitidine.
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 study is testing whether adding venetoclax to standard chemotherapy or to azacitidine improves how well the cancer is cleared.
- Who it's for
- You may be able to join if you are a younger adult with intermediate‑risk acute myeloid leukemia.
- What's involved
- You would receive one of three drug regimens. The study team will give you the drugs and monitor you with blood tests and visits.
- Time commitment
- The study lasts about 6 months, with regular clinic visits and blood draws during treatment.
- 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
- Participants must have been registered to master screening and re-assessment protocol (MYELOMATCH) prior to consenting to this study.
- Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
- 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
You likely can't join if
- Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts.
- 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
- Active, uncontrolled bacterial, fungal, or viral infection
See the full eligibility criteria
- Participants must have been registered to master screening and re-assessment protocol (MYELOMATCH) prior to consenting to this study.
- Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
- 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
- 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 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...
- 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 control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to the initiation...
- 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.
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
- 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.
- In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment
- 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.
- 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.
- Patients with isolated myeloid sarcoma are not eligible
- Active, uncontrolled bacterial, fungal, or viral infection
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Oakland, California, United States
- Roseville, California, United States
- San Francisco, California, United States
- Santa Clara, California, United States
- New Haven, Connecticut, 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
+ 127 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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Oakland, California, United States; Roseville, California, United States and 141 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.