RecruitingPhase 2NCT05780879

A Proof of Concept Pilot Study of the Addition of Venetoclax to Standard Remission Induction Chemotherapy Fludarabine or Cladrabine, Cytarabine, and Granulocyte Colony Stimulating Factor (G-CSF) (FLAG or CLAG) for Frontline Therapy of Secondary Acute Myeloid Leukemia


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

20 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to determine complete remission rate of a novel combination induction chemotherapy treatment based upon 20 patients with newly diagnosed secondary AML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing whether adding venetoclax — a targeted cancer drug — to a standard chemotherapy regimen (FLAG or CLAG) can improve outcomes for people newly diagnosed with secondary acute myeloid leukemia (AML). Secondary AML develops from a prior blood disorder or as a result of earlier cancer treatments. **You may be eligible if:** - You have a newly confirmed diagnosis of secondary acute myeloid leukemia (AML), which includes AML that developed from a prior blood condition (like MDS, aplastic anemia, or myeloproliferative neoplasm), or AML that arose after prior cancer therapy - You have not previously been treated for AML - Your organ function and blood counts are adequate for chemotherapy **You may NOT be eligible if:** - You have previously received treatment for AML - You have significant health conditions that prevent you from tolerating intensive chemotherapy - You do not meet the specific diagnostic criteria for secondary AML 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

DRUGVenetoclax

Venetoclax administered orally once daily on days 3-16.

DRUGFLAG or CLAG Protocol

FLAG consists of daily infusions of Fludarabine (30mg/m2/day over 30 minutes) and Ara-C (2g/m2/day over 4 hours) for 5 days with daily subcutaneous injections of G-CSF until count recovery. Tbo-filgrastim will be administered as follows: WBC count \>50,000 - 5mcg/kg; WBC count \<50,000 - hold Tbo-filgrastim. Given the national shortage of Fludarabine, Cladrabine (5mg/m2/day IV over 2 hours) has been substituted (CLAG) with similar toxicity profile.


Locations(1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

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NCT05780879


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