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ABBV-787 for Acute Myeloid Leukemia
Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
QT interval corrected for heart rate (QTc) <= 470 msec using Fridericia's correction, and no other clinically significant cardiac abnormalities.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug, ABBV-787, for adults with acute myeloid leukemia that hasn't responded to other treatments. The drug is given through an IV, and the study aims to find the safest dose while monitoring its effects and side effects.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) who have tried up to three treatments without success. They should be in good physical condition (ECOG score of 0 or 1), have acceptable heart health, and a white blood cell count below a certain level. People can't join if they've had more than three prior AML treatments or don't meet specific health criteria.
What is being tested?
The study tests the safety and behavior of ABBV-787, an experimental drug for AML, when given through IV. Participants will receive increasing doses to find the highest dose they can tolerate without severe side effects over approximately three years.
What are the potential side effects?
Potential side effects include reactions related to infusion, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea, and other symptoms that may arise from higher doses as the maximum tolerated dose is determined.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
My heart's electrical activity is normal, with no significant issues.
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I have been diagnosed with a specific type of leukemia that is not promyelocytic.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD) Based on Dose-Limiting Toxicities (DLT)
Number of Participants with Adverse Events (AE)
Secondary study objectives
Antidrug Antibody (ADA)
Area Under the Plasma Concentration-time Curve (AUC) of ABBV-787
Duration of Response (DOR)
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ABBV-787Experimental Treatment1 Intervention
Participants will receive increasing doses of ABBV-787 until the maximum tolerated dose (MTD) during the 3 year treatment period.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapy, and investigational drugs. Chemotherapy agents, such as cytarabine and anthracyclines, disrupt DNA replication and cell division, causing the death of leukemia cells.
Targeted therapies focus on specific genetic mutations or proteins that promote leukemia cell growth, such as FLT3, IDH, and BCL-2 inhibitors. Investigational drugs like ABBV-787 aim to target novel pathways or molecules involved in AML.
Understanding these mechanisms is essential for tailoring treatment to the patient's specific leukemia profile, potentially improving outcomes and minimizing side effects.
Role of epigenetic in leukemia: From mechanism to therapy.Emerging Epigenetic Therapeutic Targets in Acute Myeloid Leukemia.Molecular targeting in acute myeloid leukemia.
Role of epigenetic in leukemia: From mechanism to therapy.Emerging Epigenetic Therapeutic Targets in Acute Myeloid Leukemia.Molecular targeting in acute myeloid leukemia.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,035 Previous Clinical Trials
523,005 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,640 Total Patients Enrolled