A Phase 2 interventional study of Avatrombopag in Thrombocytopenia, sponsored by University of Virginia. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University of Virginia · Phase 2, Interventional, and Prevention
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:
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.
This is a phase II, single center, open-label trial that evaluates the use of a commercially available oral prophylactic thrombopoietin-receptor agonist (avatrombopag [Doptelet]) to reduce thrombocytopenia and improve recovery and outcomes post-CAR T-cell therapy in adult patients with lymphoma and myeloma who are at high risk of thrombocytopenia post CAR T-Cell Therapy.
Avatrombopag is to be administered orally, 10 days prior to standard of care CAR T-Cell Infusion, at a starting dose of 20 mg (1 tablet), once daily, with food, in accordance with the package insert, with the exceptions to reduce the risk of excessive thrombocytosis or development of a clot. Avatrombopag is to be taken for 39 days.
Avatrombopag is to be taken at home. Participants will be given a pill diary.
Participants will be assessed for disease status at day 60 and in follow-up. Participants will be asked to complete a Quality of Life Survey, once at baseline and once in follow-up.
703 studies on the registry are indexed under Thrombocytopenia; 150 are open to participants now.
This study's planned enrollment of 26 is below the median of 55 across 475 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →University of Virginia is the lead sponsor of 673 studies on the registry; 139 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least one of the following:
Organ Function per the following criteria:
Plt - >20K CrCl - >30 ml/min, (expectation for participants with chronic kidney disease presenting with CrCl \<30 but within 15% of baseline) Bilirubin - \<3.0 (unless diagnosed with Gilbert's, can be to PI discretion) AST and ALT - ≤ 3 x ULN
Exclusion Criteria:
All participants are anticipated to receive a 39 day supply of oral Avatrombopag.
Drug: Avatrombopag
Avatrombopag (Doptelet) - immediate-release tablet, 20 mg
Number of participants with platelets ≥50K
Number of participants with platelets ≥50K for 2 consecutive laboratory checks within 1 week, and one of those measures occurring at day 28. The last platelet transfusion must be \>2 days from the first day of platelets ≥50K.
Time frame: From enrollment to Day 35
Number of participants with platelets ≥30K at day 28
Number of participants with platelets ≥30K at day 28
Time frame: From time of enrollment to day 28
Number of participants with platelets ≥30K at day 14
Number of participants with platelets ≥30K at day 14
Time frame: From time of enrollment to day 14
Platelets ≥100K at day 28
Platelets ≥100K at day 28
Time frame: From enrollment to day 28
Platelet transfusion independence
Days from first platelet transfusion to first day of platelets ≥10K without transfusion for 24 hours prior
Time frame: From day of first platelet transfusion until first day of platelets ≥10K without transfusion for 24 hours prior
Length of stay
Number of inpatient days from Day 0 to Day 60
Time frame: From Day 0 to Day 60
≥ grade 3 AEs related to drug
≥ grade 3 AEs related to drug; unacceptable toxicities leading to discontinuation of drug
Time frame: From Day -10 to Day 60
Post infusion CRS
CRS graded per ASTCT guidelines after infusion of CAR T cell therapy
Time frame: From Day 0 to Day 90
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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