Actively Recruiting
A Prospective, Multicenter, Randomized, Open-Label, Phase II Study of Salvage BCL2i Plus CLAG-M in Relapsed or Refractory Acute Myeloid Leukemia
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
52
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating a combination therapy for adults with relapsed or refractory acute myeloid leukemia (AML) in this multicenter, open-label phase II study. The study aims to see if adding the drug venetoclax to the CLAG-M chemotherapy regimen (cladribine, cytarabine, G-CSF, mitoxantrone) improves the clearance of measurable residual disease and event-free survival compared to CLAG-M alone. This trial is led by the H. Lee Moffitt Cancer Center and Research Institute.
CONDITIONS
Brief 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 to 80 years.
- Documented refractory or relapsed AML as defined by study criteria.
- Secondary AML from MDS treated with HMA, HMA + venetoclax (if more than 3 months since venetoclax), or 1 cycle of induction chemotherapy.
- Extramedullary AML allowed if marrow involvement is present.
- ECOG performance status of 2 or less.
- Adequate organ function per protocol.
- HIV-infected participants on effective therapy with undetectable viral load within 6 months.
- HBV viral load undetectable on suppressive therapy if indicated.
- Treated HCV infection with undetectable viral load or currently on treatment with undetectable viral load.
- Agreement to use contraception for women of childbearing potential and men during and 4 months after study drug administration.
You will not qualify if you...
- Venetoclax-refractory disease or venetoclax exposure less than 3 months before study therapy.
- Prior treatment with high-dose cytarabine regimens like CLAG, FLAG, MEC, CLIA, or HAM.
- Allogeneic stem cell transplant within the past 3 months.
- Less than 14 days since last AML therapy or five half-lives, excluding hydroxyurea.
- Known prior TP53 mutation.
- Active CNS involvement by AML.
- White blood cell count over 25,000 at treatment start.
- Uncontrolled systemic illness limiting compliance.
- Concurrent malignancy requiring active treatment with some exceptions.
- Immunosuppressive therapy within 14 days except low-dose prednisone and no active graft-versus-host disease.
- Unresolved adverse events from prior therapy greater than Grade 1 except alopecia.
- Receiving other investigational agents.
- Psychiatric or social issues limiting compliance.
- Active heart disease limiting mitoxantrone use or recent acute cardiovascular events within 6 months.
- Pregnant or breastfeeding women due to potential risks from study drugs.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 days per treatment cycle
Participants receive multiagent chemotherapy with CLAG-M regimen, with or without oral Venetoclax, to treat relapsed or refractory acute myeloid leukemia.
Daily visits during treatment cycle
Duration - Up to 18 months
Participants are monitored for treatment response, side effects, and overall health for up to 18 months after treatment.
Regular visits as scheduled by the study team
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
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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