RecruitingPhase 2NCT06660368

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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

52 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory Acute Myeloid Leukemia (AML)

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of chemotherapy drugs (CLAG-M) with venetoclax (a BCL2 inhibitor that blocks a protein that helps cancer cells survive) in adults with relapsed or treatment-resistant acute myeloid leukemia (AML) — a fast-growing blood cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have AML that has come back after treatment or did not respond to at least one course of intensive chemotherapy - You are generally well enough to function (ECOG performance status 0–2) - Your heart, liver, and kidneys are functioning adequately - If you have HIV, it is well controlled on treatment **You may NOT be eligible if...** - You have certain serious infections, organ failure, or other cancers - You have had too recent exposure to venetoclax (within 3 months) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Filgrastim/G-CSF 300 mcg/day for 6 days beginning 24 hours prior to multiagent chemotherapy (days 0-5), cladribine 5 mg/m2 given intravenously over 2 hours for 5 consecutive days (days 1-5), cytarabine given IV over 4 hours for 5 consecutive days (days 1-5) beginning 2 hours after the completion of cladribine, and mitoxantrone 16 mg/m2 given intravenously over 30 minutes for 3 days (days 1-3) after completion of cytarabine.

DRUGVenetoclax

Venetoclax will be administered orally, once daily, with food.

Locations(2)

Moffitt Cancer Center

Tampa, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06660368

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