BCL2i CLAG-M in R/R Acute Myeloid Leukemia

A Prospective, Multicenter, Randomized, Open-Label, Phase II Study of Salvage BCL2i Plus CLAG-M in Relapsed or Refractory Acute Myeloid Leukemia

NCT06660368•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated informed consent form.
•Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.
•Adults aged ≥18 years - 80 years.
•Patients with documented refractory or relapsed AML: Refractory disease is defined as failure to achieve CR (i.e., \<5% blasts in BM or blood) with or without normal restoration of hematopoiesis (Cri) after at least 1 cycle of intensive induction therapy (or 2 cycles of non-intensive induction). Relapse: Recurrence of disease after achieving remission, meeting one or more of the following criteria: ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease.
•Secondary AML arising out of MDS previously treated with HMA, HMA + venetoclax (if \> 3 months from venetoclax exposure), and/or 1 cycle of induction chemotherapy.
•Extramedullary AML with marrow involvement is allowed as long as concurrent medullary AML is present.
•ECOG performance status ≤ 2.
•Participants must have adequate organ function as defined within the protocol.
•Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not mandatory.
•For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
+1 more criteria

Exclusion Criteria

•Venetoclax-refractory disease or recent venetoclax exposure \< 3 months prior to first dose of study therapy.
•Prior treatment with a high-dose cytarabine-containing regimen (e.g., no prior CLAG/FLAG/MEC/CLIA/HAM, etc.).
•Allogeneic stem cell transplant in the past 3 months.
•Less than 14 days from last AML-directed therapy or five half-lives, whichever is shorter, not including hydroxyurea.
•Known history of prior TP53 mutation (results from any myeloid mutation panel are not required for screening eligibility).
•Active CNS involvement by AML.
•WBC count ≥25k at the time study treatment begins.
•Uncontrolled intercurrent systemic illness that would limit compliance.
•Concurrent malignancy in addition to AML that requires active treatment with some exceptions.
•Immunosuppressive therapy in the past 14 days except for prednisone at ≤ 10 mg/day or equivalent AND no active or uncontrolled graft-versus-host disease (GvHD).
+5 more criteria

Locations (2)

Moffitt Cancer Center

Tampa, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

November 26, 2024

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2027

Last Updated

January 29, 2026

Enrollment

ESTIMATED participants

Conditions

Relapsed or Refractory Acute Myeloid Leukemia (AML)

Interventions

Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen

DRUG

Venetoclax

DRUG

Contacts

Quan Lovette

CONTACT

813-745-4194 quan.lovette@moffitt.org

Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

NCT02074839

Relapsed or Refractory Acute Myeloid Leukemia (AML)Untreated AML+2 more

View study

RECRUITINGPHASE2

A Study of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT05241106

Relapsed or Refractory Acute Myeloid Leukemia (AML)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions