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ABBV-787 for Acute Myeloid Leukemia

Q: Has the FDA granted authorization to ABBV-787?

The safety of ABBV-787 can only be estimated as a 1, since Phase 1 trials lack comprehensive clinical data to support both efficacy and security.

Q: Are there still positions available in this clinical trial for participants?

Yes, the database hosted on clinicaltrials.gov reveals that recruitment is still underway for this medical trial. It was initially posted on November 22nd 2023 and recently updated a few weeks later in mid-November of 20203.

Q: What is the participant capacity for this research endeavor?

Indeed, the listing on clinicaltrials.gov states that enrolment is still open for this investigation which first opened to participants in November of 2023. The trial has been recently adjusted and currently requires 60 individuals at a single site.

Q: What are the projected results of this medical trial?

The main objective of the AbbVie trial, as reported by its sponsor, is to measure the number of adverse events over a period not exceeding 28 days. Secondary goals include counting participants that proceed with hematopoietic stem cell <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a> (HSCT), assessing plasma concentration-time curve (AUC) for ABBV-787 and measuring total antibody concentration.

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

Study Summary

This trial is assessing a potential new treatment for adults with relapsed/refractory acute myeloid leukemia (AML). About 60 participants will receive ABBV-787 to determine its safety and effectiveness.

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.Check my eligibility

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.See study design

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 below

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I am fully active or can carry out light work.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) Based on Dose-Limiting Toxicities (DLT)

Number of Participants with Adverse Events (AE)

Secondary outcome measures

Antidrug Antibody (ADA)

Area Under the Plasma Concentration-time Curve (AUC) of ABBV-787

Duration of Response (DOR)

+15 more

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

967 Previous Clinical Trials

503,496 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

404 Previous Clinical Trials

148,030 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted authorization to ABBV-787?

"The safety of ABBV-787 can only be estimated as a 1, since Phase 1 trials lack comprehensive clinical data to support both efficacy and security."

Answered by AI

Are there still positions available in this clinical trial for participants?

"Yes, the database hosted on clinicaltrials.gov reveals that recruitment is still underway for this medical trial. It was initially posted on November 22nd 2023 and recently updated a few weeks later in mid-November of 20203."

Answered by AI

What is the participant capacity for this research endeavor?

"Indeed, the listing on clinicaltrials.gov states that enrolment is still open for this investigation which first opened to participants in November of 2023. The trial has been recently adjusted and currently requires 60 individuals at a single site."

Answered by AI

What are the projected results of this medical trial?

"The main objective of the AbbVie trial, as reported by its sponsor, is to measure the number of adverse events over a period not exceeding 28 days. Secondary goals include counting participants that proceed with hematopoietic stem cell transplant (HSCT), assessing plasma concentration-time curve (AUC) for ABBV-787 and measuring total antibody concentration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Adverse Events and Movement of Intravenously (IV) Infused ABBV-787 in Adult Participants With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

2023. "Study to Evaluate Adverse Events and Movement of Intravenously (IV) Infused ABBV-787 in Adult Participants With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06068868.