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Chemotherapy
Venetoclax + FLAG Chemotherapy for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Led By Dale Bixby, MD, PhD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 1 year following the conclusion of study enrollment
Awards & highlights
Study Summary
This trial tests a new chemo treatment for 20 people with secondary acute myeloid leukemia to see if it can make them go into remission.
Who is the study for?
Adults diagnosed with secondary acute myeloid leukemia (AML) who haven't had treatment for it, except possibly hydroxyurea or leukopheresis. They should be in relatively good health (ECOG PS ≤ 2), able to understand and consent to the study, and commit to its duration. Adequate organ function is required, and they must use effective contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial tests a new chemotherapy combo using Venetoclax with either FLAG or CLAG protocol on patients with newly diagnosed secondary AML. The goal is to see how many achieve complete remission after this frontline therapy based on an evaluation of 20 participants.See study design
What are the potential side effects?
Possible side effects include fatigue, digestive issues like nausea or constipation, low blood cell counts leading to increased infection risk or bleeding problems, liver enzyme changes suggesting liver damage, kidney function impairment, and allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year after study entry
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after study entry
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone marrow aplasia
Morphologic complete remission (CR)
Number of patients who develop drug-related non-hematologic grade 3 or higher toxicity
+1 moreSecondary outcome measures
Allogeneic transplantation
Event free survival (EFS)
Mortality rate
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Venetoclax + FLAG or CLAG induction chemotherapyExperimental Treatment2 Interventions
Induction chemotherapy with FLAG starting on day 1 and venetoclax given on days 3-16. The G-CSF component of FLAG will continue until count recovery (ANC at least > 1000). FLAG dosing will be standard and uniform for all patients and venetoclax dosing will be determined according to institutional guidelines based on the prophylactic antifungal therapy chosen for use during induction therapy. Given the national shortage of Fludarabine, Cladrabine (5mg/m2/day IV over 2 hours) has been substituted (CLAG) with similar toxicity profile.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,241 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,123 Total Patients Enrolled
Dale Bixby, MD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on specific leukemia treatments except for hydroxyurea or Bcl-2 inhibitors.I can understand and am willing to sign the consent form.I need to use extra oxygen all the time due to a lung condition.My organs are functioning well.My heart condition limits my physical activity significantly.I have not received any live vaccines in the last 28 days.I cannot take medications by mouth due to a digestive condition.I can take care of myself and perform daily activities.I have not been treated for another cancer within the last 3 months.I do not have any infections or illnesses that could affect the study.I have been diagnosed with a specific type of leukemia called secondary AML.I am 18 years old or older.I have HIV, Hepatitis B, or C but my viral load has been undetectable for the last 3 months.I have symptoms of leukemia in the fluid around my brain and spinal cord.I haven't had treatment for secondary AML, except possibly hydroxyurea or leukopheresis.I have been diagnosed with a specific type of leukemia.I am allergic to certain chemotherapy drugs being studied.I haven't taken strong or moderate CYP3A inducers in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Venetoclax + FLAG or CLAG induction chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical study taking on new participants?
"Clinicaltrials.gov reveals that this clinical trial, which was initially shared on March 1st 2023 and last modified on March 10th 2023, is no longer accepting participants. Despite this setback, there are still 2104 other medical studies searching for volunteers at the moment."
Answered by AI
To what extent can Venetoclax + FLAG induction chemotherapy be detrimental for individuals?
"Having reviewed the available information, our team at Power assigned Venetoclax + FLAG induction chemotherapy a rating of 2 on a 1 to 3 scale. This is due to this being Phase 2 trial and thus lacking evidence for efficacy but providing some indication of safety."
Answered by AI
What are the prime goals of this research endeavor?
"The primary purpose of this trial, tracked over a 30 day-period post treatment initiation, is to achieve morphologic complete remission (CR). Furthermore, secondary aims include the analysis and evaluation of Progression-free survival (PFS), Event free survival (EFS) and Overall Survival (OS) using Kaplan Meier methods."
Answered by AI
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