A Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06773208
Phase
PHASE2
Status
Recruiting

Conditions

  • Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine (AZC) — DRUG
    75 mg/m2 daily, on days 1-7, given IV or SC
  • Venetoclax — DRUG
    Venetoclax 400 mg orally daily on days 1-28

Study Details

The purpose of this study is to find out if azacitidine and venetoclax are an effective treatment approach to get rid of or lower measurable residual disease (MRD) in people with acute myeloid leukemia (AML) who have received standard chemotherapy and are planning to have an allogeneic hematopoietic stem cell transplant (HSCT). Allogeneic HSCT, sometimes called a bone marrow transplant, involves receiving healthy blood-forming cells (stem cells) from a donor in order to replace the patient's immune system and lower the chances of the disease returning (relapse).

Key Dates

Start date
Jan 7, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Azacitidine and Venetoclax
    Cycle length: 28 days Azacitidine 75 mg/m2 daily, on days 1-7, given IV or SC (generally given IV in our institution) Venetoclax 400 mg orally daily on days 1-28

Primary Outcome Measure

rate of MRD conversion [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Meira Yisraeli Salman, MD
646-608-3982
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Meira Yisraeli Salman, MD
646-608-3982
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Meira Yisraeli Salman, MD
646-608-3982
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)CommackNew York11725
Meira Yisraeli Salman, MD
646-608-3982
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Meira Yisraeli Salman, MD
646-608-3982
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Meira Yisraeli Salman, MD
646-608-3982
Memorial Sloan Kettering Nassau (All Protocol Activities)Rockville CentreNew York11553
Meira Yisraeli Salman, MD
646-608-3982

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