Study Details

Open

Acute Myeloid Leukemia Study

This is a research study for people diagnosed with AML. The purpose of this study is to see if the treatment of a combination of two drugs (cytarabine liposome therapy) and adding a third drug (pomalidomide) in different doses is more effective.

Age & Gender

18 years ~ 75 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

If you choose to take part, you will get the study drugs through an IV for about 1-1/2 hours on Days 1, 3 and 5 during induction therapy. You may have a second round of induction therapy. It's possible you may stay in the hospital to monitor your safety. After receiving the IV study drugs, you will be placed into one of two groups to receive a third medication in tablet form (pomalidomide). Each visit includes blood tests, a physical exam, and questions about how you feel. You will also have mandatory bone marrow biopsies and blood samples a few times during the study. During the second part of the study, you will be placed in one of two groups to receive another combination of the study medications. We will also do a physical exam, blood tests and bone marrow biopsies during this time.

Incentives

Study Medication

In-person visits:
23

Total length of participation:
5 years after the start of induction therapy

Looking for Specific Volunteers

Able to participate:

You have confirmation of AML by bone marrow aspirate and/or biopsy.
You have not received prior medication treatments for AML
You are between the ages of 18 and 75 years old.
You have good liver and kidney function.
you have had other bone marrow cancers or genetics that reflect prior bone marrow cancers

Not eligible if:

You have any other active and secondary cancer that requires treatment.
You have received 2 or more doses of daunorubicin with radiation therapy.
You have active central nervous system leukemia
You have active and uncontrolled infection, or heart disease.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Joshua Zeidner
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Leukemia)

IRB Number

21-2335

ClinicalTrials.gov

NCT04802161