RecruitingPhase 2NCT04801797

Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

A Phase 2 Randomized Study Comparing Venetoclax and Azacitidine to Induction Chemotherapy for Newly Diagnosed Fit Adults With Acute Myeloid Leukemia


Sponsor

Massachusetts General Hospital

Enrollment

172 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This research is being done to assess the therapeutic activity of a promising combination (azacitidine and venetoclax) versus conventional cytotoxic chemotherapy in induction-eligible patients with acute myeloid leukemia. This study involves the following: * Venetoclax and azacitidine (investigational combination) * Cytarabine and idarubicin or daunorubicin (per standard of care) or Liposomal daunorubicin and cytarabine (per standard of care)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for newly diagnosed acute myeloid leukemia (AML) — a blood cancer — to determine whether a gentler pill-and-injection combination (venetoclax plus azacitidine) works as well as or better than traditional intensive chemotherapy, particularly for patients who may not tolerate aggressive treatment. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with AML (confirmed by bone marrow or blood test showing 20% or more abnormal cells) - You have not received prior treatment for AML **You may NOT be eligible if...** - You have received prior chemotherapy for AML - You have certain genetic markers that require a different treatment approach - You have severe organ problems that prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCytarabine

Intravenous infusion

DRUGIdarubicin

Intravenous infusion

DRUGDaunorubicin

Intravenous infusion

DRUGLiposomal daunorubicin and cytarabine

Intravenous infusion

DRUGVenetoclax

Orally by mouth

DRUGAzacitidine

Intravenous infusion


Locations(9)

City of Hope

Duarte, California, United States

Stanford Cancer Center

Palo Alto, California, United States

University of California - Davis

Sacramento, California, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

Ohio State University Medical Center

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT04801797


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