Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05342584
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase 1b, open-label study evaluating Venetoclax in combination with intensive induction and consolidation chemotherapy in previously untreated, adult patients with acute myeloid leukemia. In Part 1, the dose escalation phase, the safety and tolerability of the combination with Venetoclax at different doses and duration will inform the appropriate dose(s) and regimen(s) for Part 2. In Part 2, the dose expansion phase, a maximum of 28 additional patients will be randomized 1:1 to the MTD determined in Part 1 and the starting dose (assuming the MTD is not the starting dose), to further evaluate the safety and efficacy of the study drug combination.

Key Dates

Start date
May 25, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Venetoclax plus 7+3
    see detailed description

Primary Outcome Measure

Frequency and Severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Through study completion, up to 6 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM)The BronxNew York10467
Ioannis Mantzaris, MD
[email protected]
718-920-4826
Amit K Verma, MD
718-430-2205

Find similar trials in The Bronx, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Montefiore Einstein Cancer Center and Children's Hospital at Montefiore (CHAM)· The Bronx, NY

Related Studies