ThrombocytopeniaPhase 2CAR-T 002NCT07895017
Time-limited Treatment With Avatrombopag Pre- and Post-CAR T-cell Therapy to Prevent Post-CAR T-cell Cytopenias
A Phase 2 study testing Avatrombopag in people with Thrombocytopenia, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Avatrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 years old
- ECOG performance status ≤ 2
- Planned to receive FDA approved CAR T-cell therapy for large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, chronic lymphocytic lymphoma, or multiple myeloma including (but not limited to): idecabtagene vicleucel, lisocabtagene maraleucel, ciltacabtagene autoleucel, tisagenlecleucel, brexucabtagene autoleucel, or axicabtagene ciloleucel
- At least one of the following:
Show all 12Show fewer
- Platelet count <200K
- High CAR-HEMATOTOX score
- 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
- Ability to take oral medication and be willing to adhere to the avatrombopag regimen
- Agreement to adhere to Lifestyle Considerations throughout study duration
Who cannot join
- Subjects who are at increased risk for thromboembolism, including patients with platelets > 400k/ul, previously known genetic prothrombotic conditions (e.g., Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency) and acquired risk factors (e.g., antiphospholipid syndrome).
- Pregnancy (urine or blood beta-hcg) or lactation
- Known allergic reactions to components of the avatrombopag, specifically subjects with anaphylaxis, bleeding, or other severe adverse reactions related to avatrombopag or its components
- Treatment with another investigational drug within 3 weeks prior to registration.
- Subjects with acute arterial or venous thromboembolism within the past 6 months
- Subjects with a history of MDS or AML
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
Ann Brown, 434-243-5721, amb8e@uvahealth.org
About this study
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
Read more
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.
Read the detailed description
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.
- Conditions
- Thrombocytopenia
- Being tested
- Avatrombopag
- Keywords
- car-t, cell therapy, cytopenia, thrombocytopenia, Car T-Cell Therapy, prolonged cytopenia, multiple myeloma, lymphoma, avatrombopag, doptelet
- Medical subject headings
- Thrombocytopenia, Cytopenia, Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvatrombopagDrug
Avatrombopag (Doptelet) - immediate-release tablet, 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Avatrombopag Arm | Experimental | All participants are anticipated to receive a 39 day supply of oral Avatrombopag. Receives: Drug: Avatrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to Day 35
Secondary outcomes (7)
Number of participants with platelets ≥30K at day 28
Number of participants with platelets ≥30K at day 28
Measured: 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
Measured: From time of enrollment to day 14
Platelets ≥100K at day 28
Platelets ≥100K at day 28
Measured: 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
Measured: 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
Measured: 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
Measured: From Day -10 to Day 60
Post infusion CRS
CRS graded per ASTCT guidelines after infusion of CAR T cell therapy
Measured: From Day 0 to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Sobi, Inc.
- Responsible party
- Principal investigator, Krithika Shanmugasundaram, University of Virginia
- Investigators
- Krithika Shanmugasundaram, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895017
- Sponsor's protocol ID
- HSR302741
- Acronym
- CAR-T 002
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-limited Treatment With Avatrombopag Pre- and Post-CAR T-cell Therapy to Prevent Post-CAR T-cell Cytopenias
- ClinicalTrials.gov ID
- NCT07895017
- Acronym / sponsor ID
- CAR-T 002 / HSR302741
- Conditions
- Thrombocytopenia
- Keywords
- car-t, cell therapy, cytopenia, thrombocytopenia, Car T-Cell Therapy, prolonged cytopenia, multiple myeloma, lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Sobi, Inc.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avatrombopag Arm | Experimental | Drug: AvatrombopagAll participants are anticipated to receive a 39 day supply of oral Avatrombopag. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 years old
- ECOG performance status ≤ 2
- Planned to receive FDA approved CAR T-cell therapy for large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, chronic lymphocytic lymphoma, or multiple myeloma including (but not limited to): idecabtagene vicleucel, lisocabtagene maraleucel, ciltacabtagene autoleucel, tisagenlecleucel, brexucabtagene autoleucel, or axicabtagene ciloleucel
Key exclusion criteria (6 listed)
- Subjects who are at increased risk for thromboembolism, including patients with platelets > 400k/ul, previously known genetic prothrombotic conditions (e.g., Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency) and acquired risk factors (e.g., antiphospholipid syndrome).
- Pregnancy (urine or blood beta-hcg) or lactation
- Known allergic reactions to components of the avatrombopag, specifically subjects with anaphylaxis, bleeding, or other severe adverse reactions related to avatrombopag or its components
- Treatment with another investigational drug within 3 weeks prior to registration.
- Subjects with acute arterial or venous thromboembolism within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvatrombopagAvatrombopag (Doptelet) - immediate-release tablet, 20 mg | Drug | Avatrombopag Arm |
Primary outcome
Number of participants with platelets ≥50K
Time frame: From enrollment to Day 35
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.
7 secondary outcomes
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
Time frame: From time of enrollment to day 14
Platelets ≥100K at day 28
Time frame: From enrollment to day 28
Platelet transfusion independence
Time frame: From day of first platelet transfusion until first day of platelets ≥10K without transfusion for 24 hours prior
Length of stay
Time frame: From Day 0 to Day 60
≥ grade 3 AEs related to drug
Time frame: From Day -10 to Day 60
Post infusion CRS
Time frame: From Day 0 to Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krithika Shanmugasundaram, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avatrombopag in people with Thrombocytopenia, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabeena Ahmad (434-327-7492, dxp2tu@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with platelets ≥50K (time frame: From enrollment to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.