Venetoclax + Azacitidine vs. Induction Chemotherapy in AML

Acute Myeloid Leukemia Clinical Trial

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

Status Recruiting

Clinical Trial 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)

Clinical Trial Description

This is an open-label, multicenter, phase II randomized clinical trial to compare the therapeutic activity of conventional induction chemotherapy (7+3 regimen or liposomal daunorubicin and cytarabine) to the combination of venetoclax and azacitidine among fit, traditionally induction-eligible adults with newly diagnosed acute myeloid leukemia (AML).

The U.S. Food and Drug Administration (FDA) has approved the combinations of liposomal daunorubicin and cytarabine as well as cytarabine and idarubicin or daunorubicin as treatment options for acute myeloid leukemia (AML)

The FDA has approved the combination of venetoclax and azacitidine for people with acute myeloid leukemia (AML) that are over the age of 75 or who have comorbidities that preclude intensive induction chemotherapy.

Venetoclax may interact with BCL-2 (a protein that initiates tumor growth, disease progression, and drug resistance) and inhibit BLC-2 which can lead to cancer cell death. Azacitidine may cause cell death in rapidly dividing cells, which may lead to cancer cell death since cancer cells do not grow at a normal rate. Induction Chemotherapy which includes the drugs idarubicin or daunorubicin, cytarabine, and liposomal daunorubicin and cytarabine is the standard of care chemotherapy treatment for someone with acute myeloid leukemia (AML).

The research study procedures include screening for eligibility and study treatment, including evaluations and follow up visits.

Participants will receive study treatment for as long as they and their doctor believe they are benefitting from the study drugs. Participants will then be followed for 3 years or until they withdraw their consent to be contacted.

It is expected that about 172 people will take part in this research study.

AbbVie, a biopharmaceutical company, is supporting this research study by providing funding for the study, including one of the study drugs. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

• NCT number: NCT04801797
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Amir T Fathi, MD
• Phone: (617) 724-1124
• Email: afathi@mgh.harvard.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2021
• Completion date: January 1, 2026