Avatrombopag for Thrombocytopenia

(CAR-T 002 Trial)

SA
Overseen BySabeena Ahmad
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to study how avatrombopag (the study drug) may prevent certain side effects in adults with lymphoma and myeloma getting cancer treatment (CAR-T cell therapy). CAR (Chimeric Antigen Receptor) -T cell therapy is a common way to treat lymphoma and myeloma. However, during this kind of cell therapy a patient is at risk of developing lower-than-normal blood cell counts, including:

* Red Blood Cells - important for many functions such as moving oxygen from the lungs to the body and moving carbon dioxide (CO2) back to the lungs

* White Blood Cells - help fight against infection(s)

* Platelets - help stop bleeding by forming clots when there is an injury

When a person's platelet counts are lower than normal, this is called "thrombocytopenia". If you have thrombocytopenia, your body has a harder time stopping a bleed when there is an injury to a blood vessel. Thrombocytopenia over time may require additional treatments such as blood transfusions (getting extra platelets).

Avatrombopag is a drug that has been shown to increase platelet numbers in people with other kinds of conditions. This study is trying to find out if taking avatrombopag both before and after CAR-T cell therapy will prevent platelet counts from getting too low.

This is a research study to see if taking avatrombopag (in the form of pills) before, during, and after CAR-T cell therapy will reduce the chance of having thrombocytopenia as a side effect.

This study is for people who are at high risk of thrombocytopenia after CAR T-Cell Therapy.

Who Is on the Research Team?

KS

Krithika Shanmugasundaram, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for adults with lymphoma or multiple myeloma who are about to receive CAR-T cell therapy and are at high risk of having low platelet counts (thrombocytopenia) after treatment.

Inclusion Criteria

Provision of signed and dated informed consent form
At least one of the following: Platelet count <200K or High CAR-HEMATOTOX score
Agreement to adhere to lifestyle considerations throughout study duration
See 6 more

Exclusion Criteria

I have a higher risk of blood clots due to medical conditions or high platelet count.
I have had a blood clot in an artery or vein within the last 6 months.
Pregnancy or lactation
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Avatrombopag

Trial Overview

The study tests if taking avatrombopag pills before, during, and after CAR-T cell therapy can help prevent dangerously low platelet levels in people being treated for lymphoma or multiple myeloma.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Avatrombopag ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Sobi, Inc.

Industry Sponsor

Trials
14
Recruited
1,000+