A Randomized, Multicenter, Phase II Study of Maintenance Azacitidine and Venetoclax Versus an Allogeneic Stem Cell Transplant in Older Patients (65 Years and Older) With Acute Myeloid Leukemia Who Achieve an MRD Negative Complete Remission After Induction With Azacitidine and Venetoclax

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The researchers are doing this study to find out if an allogeneic hematopoietic stem cell transplant (HSCT) or maintenance therapy with azacitidine and venetoclax is more effective at keeping AML from coming back (relapsing).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Adult patients ≥65 years of age at the time of signing the informed consent form.

• Confirmed diagnosis of acute myeloid leukemia according to the ELN 2017 criteria

• Treatment with azacitidine and venetoclax for the diagnosis of AML

• o The first cycle of study treatment will start 28-42 days after the start of the second cycle of SOC AZA/VEN. In the event that patients can't be admitted for allo-HCT until after Day 42 due to donor related issues, an additional cycle of AZA/VEN will be allowed as a bridge to the transplant, and then initiation of conditioning will start no later than day 42 after the start of the third cycle.

• Patients with adequate organ function to be considered as candidates for allo-HCT:

‣ Cardiac: asymptomatic or if symptomatic, then LVEF at rest must be \>40% and must improve with exercise.

⁃ Renal: CrCl ≥50 ml/min (measured or calculated/estimated).

⁃ Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)

⁃ Hepatic: \< 5x ULN liver function tests and \< 2x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.

⁃ KPS of ≥ 70

• Patients with suitable donor for allo-HCT

• Patients must achieve a morphologic remission \<5% blast with MRD negative status by flow cytometry (defined as one or less residual leukemic blasts per 1000 leukocytes (or 10\^3)) meeting one of the below:

‣ Complete remission (CR) defined as: \<5% blasts with ANC\> 1000 AND Plt \>100K

⁃ CRh defined as \<5% blasts with ANC \> 500 AND Plt \>50K

⁃ CRi defined as \<5% blasts with ANC\< 1000 OR Plt \< 100K

• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

Locations
United States
New Jersey
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Consent and Follow-up)
RECRUITING
Middletown
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Contact Information
Primary
Roni Tamari, MD
ABMTTrials@mskcc.org
646-608-3738
Backup
Eytan Stein, MD
646-608-3749
Time Frame
Start Date: 2025-06-04
Estimated Completion Date: 2027-06
Participants
Target number of participants: 100
Treatments
Experimental: maintenance arm Azacitidine and Venetoclax (AZA/VEN)
Patients randomized to the maintenance arm (AZA/VEN) will be treated with azacitidine given daily for 7 days starting on Day 1 of each Cycle (7 consecutive days or a total of 7 days with a 2 day break due to weekends or holidays is permissible). Venetoclax will be taken orally daily for 28 days. A cycle will be considered 28 days.
Experimental: Allogeneic hematopoietic stem cell transplantation (Allo-HCT arm)
Patients who are randomized to the transplant arm will start the conditioning regimen no later than 6 weeks (day 42) after C2D1 of AZA/VEN.
Sponsors
Collaborators: Genentech, Inc.
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov