Actively Recruiting
BCL2i CLAG-M in R/R Acute Myeloid Leukemia
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
52
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.
CONDITIONS
Official Title
BCL2i CLAG-M in R/R Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Willingness and ability to comply with all study procedures and availability for the study duration.
- Adults aged 18 years to 80 years.
- Documented relapsed or refractory AML, including secondary AML following MDS treated with certain therapies.
- Extramedullary AML allowed if marrow involvement is present.
- ECOG performance status of 0 to 2.
- Adequate organ function as defined by the study protocol.
- HIV-infected participants on effective antiretroviral therapy with undetectable viral load within 6 months are eligible.
- Participants with controlled hepatitis B or C infections with undetectable viral loads are eligible.
- Women of child-bearing potential and men must agree to use effective contraception before and during the study and for 4 months after treatment.
You will not qualify if you...
- Venetoclax-refractory disease or venetoclax exposure within 3 months prior to starting study treatment.
- Prior treatment with high-dose cytarabine-containing regimens such as CLAG, FLAG, MEC, CLIA, HAM.
- Allogeneic stem cell transplant within the past 3 months.
- Less than 14 days from last AML therapy or five half-lives, except hydroxyurea.
- Known prior TP53 mutation.
- Active central nervous system involvement by AML.
- White blood cell count greater than 25,000 at treatment start.
- Uncontrolled systemic illness limiting compliance.
- Concurrent malignancy requiring active treatment (with some exceptions).
- Immunosuppressive therapy within past 14 days except low-dose prednisone and no active graft-versus-host disease.
- Unresolved side effects from prior cancer therapy above grade 1, except alopecia.
- Receiving other investigational agents.
- Psychiatric or social conditions limiting study compliance.
- Active heart disease limiting mitoxantrone use or recent acute cardiovascular events within 6 months.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
Q
Quan Lovette
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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