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Monoclonal Antibodies
Magrolimab and Venetoclax Combinations for Acute Myeloid Leukemia (ENHANCE-2 Trial)
Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate cardiac function as demonstrated by: Lack of symptomatic congestive heart failure and clinically significant cardiac arrhythmias and ischemic heart disease LVEF > 50% for individuals appropriate for intensive therapy
Individuals must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 milliliters per minute calculated by the Cockcroft Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first cr or crh achieved within 6 months for the magrolimab + azacitidine; control arm: venetoclax + azacitidine arm, and 2 months for control arm: 7+3 chemotherapy up to the end of study (up to 27 months)
Awards & highlights
ENHANCE-2 Trial Summary
This trial will compare the effectiveness of two different combinations of drugs for people with a certain type of leukemia who are not healthy enough for intensive treatment. The goal is to see which combination leads to better overall survival rates.
Who is the study for?
This trial is for adults with newly diagnosed acute myeloid leukemia (AML) that have a TP53 gene mutation. They should not have been treated for AML before, must be able to follow the study plan, and their major organs need to function well. Pregnant or breastfeeding women can't join, nor can those with certain heart conditions, other cancers, or infections like hepatitis B/C and HIV.Check my eligibility
What is being tested?
The study compares two treatments: magrolimab combined with azacitidine versus venetoclax combined with azacitidine in patients who haven't received prior treatment for TP53 mutant AML. The goal is to see which combination works better.See study design
What are the potential side effects?
Potential side effects include immune system reactions, blood cell count changes leading to increased infection risk or bleeding problems, liver issues, nausea and vomiting from chemotherapy drugs like azacitidine and venetoclax. Magrolimab may cause infusion-related reactions.
ENHANCE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart is healthy enough for intensive therapy, without heart failure or serious rhythm problems.
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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.
Select...
My liver tests are within the normal range.
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I have untreated AML with a confirmed TP53 mutation.
ENHANCE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first cr achieved within 6 months for the magrolimab + azacitidine; control arm: venetoclax + azacitidine arm, and 2 months for control arm: 7+3 chemotherapy up to the end of study (up to 27 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first cr achieved within 6 months for the magrolimab + azacitidine; control arm: venetoclax + azacitidine arm, and 2 months for control arm: 7+3 chemotherapy up to the end of study (up to 27 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy
Secondary outcome measures
Duration of CR+CRh
Duration of Complete Remission (DCR)
Event-Free Survival (EFS) in All Participants
+8 moreENHANCE-2 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Magrolimab + AzacitidineExperimental Treatment2 Interventions
Participants will receive an escalating dose of magrolimab and a fixed dose of azacitidine.
Group II: Control Arm: 7+3 ChemotherapyActive Control4 Interventions
Participants who are appropriate for intensive therapy will receive 7+3 chemotherapy: 7 day treatment with cytarabine and 3 day treatment with daunorubicin or idarubicin during induction and high-dose cytarabine and steroidal eye drops during consolidation.
Group III: Control Arm: Venetoclax + AzacitidineActive Control2 Interventions
Participants who are appropriate for non-intensive therapy will receive an escalating dose of venetoclax and a fixed dose of azacitidine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Magrolimab
2021
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,004 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,435 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mostly able to care for myself, but my ability may vary with my age and treatment plan.I have not eaten grapefruit, Seville oranges, or starfruit in the last 3 days.I have not had specific treatments for AML, but other cancer treatments are okay.I have not reached the maximum dose limit for idarubicin or similar drugs.I have a history of HBV, HCV, or HIV infection.My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.My heart is healthy enough for intensive therapy, without heart failure or serious rhythm problems.I have untreated AML with a confirmed TP53 mutation.My white blood cell count is at or below the required level for the study.I have active hepatitis B, hepatitis C, or HIV.My liver tests are within the normal range.I've taken strong or moderate drugs that affect liver enzymes within the last week.I cannot take medicine by mouth due to a condition like malabsorption.I am currently breastfeeding.I have had cancer before, but it's been inactive for over a year, except for certain types.I have been diagnosed with acute promyelocytic leukemia.I haven't taken antiviral drugs recently and my viral load has been undetectable.My doctor suspects my brain or spinal cord is affected by leukemia.I have not received a live vaccine in the last 4 weeks.I was treated with trastuzumab less than 7 months ago and am fit for intensive therapy.My hemoglobin level is at least 9 g/dL, possibly after a transfusion.I agree to use birth control as required by the study.You have a known allergy or sensitivity to any of the study drugs or their ingredients.I have a known bleeding disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm: 7+3 Chemotherapy
- Group 2: Control Arm: Venetoclax + Azacitidine
- Group 3: Magrolimab + Azacitidine
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
What is the precedent for Azacitidine in medical research?
"597 medical trials using Azacitidine are ongoing, with 111 in Phase 3. Edmonton, Alberta has several studies running concurrently, and there are a total of 22433 clinical trial locations for Azacitidine worldwide."
Answered by AI
Are researchers actively enrolling participants for this clinical trial?
"That is accurate. The website provides information that this study is looking for participants and has been since 7/1/2021 with the most recent update being on 11/4/2022. They are hoping to enroll 346 individuals from 26 different locations."
Answered by AI
Does Azacitidine have the government's okay for public consumption?
"Azacitidine is considered safe based on its score of 3. This reflects that it is a Phase 3 trial, so while there isn't extensive data supporting efficacy, there are multiple rounds of data affirming safety."
Answered by AI
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