Actively Recruiting
ADAPTiON: Apixaban Dose Adjustment in Patients With Thrombocytopenia in Oncology
Led by Rushad Patell · Updated on 2026-04-15
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of a new dose-adjusted form of apixaban for managing people with cancer-associated blood clots and low platelet counts. This early-phase study focuses on whether this treatment can be safely used in this group and aims to see if it reduces bleeding episodes. Apixaban is already FDA-approved for other blood clot conditions but has not been studied in cancer patients with thrombocytopenia before. Participants will take apixaban tablets by mouth twice daily for 90 days, with doses adjusted based on platelet counts and other factors. The study includes a baseline assessment before treatment, an off-treatment visit one week after the last dose, and a follow-up visit six weeks later. About 30 people are expected to join this research. During the study, participants will have clinic visits and blood tests to monitor their platelet levels and overall health. Researchers will track how well participants stick to the medication schedule and platelet monitoring plan, as well as record any bleeding events and recurrent blood clots. The study treatment lasts 90 days, followed by a 6-week observation period after stopping the drug to ensure ongoing safety and collect outcome data.
CONDITIONS
Brief Title
Apixaban in Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Active cancer diagnosed by tissue confirmation within the last 6 months or received cancer treatment within the last 6 months
- Newly diagnosed symptomatic deep vein thrombosis or pulmonary embolism confirmed by imaging within 28 days before enrollment
- Platelet count below 75,000 per microliter before any platelet transfusion within 28 days of clot diagnosis
- Platelet count responds to transfusion with an average increase of at least 10,000 per microliter over the last 3 transfusions if transfused
- No active bleeding
- No major bleeding requiring transfusion, hospitalization, or intervention within the past 12 months
- No known brain metastases
- ECOG performance status of 0 to 2
- Adequate liver and kidney function as defined by lab limits
- HIV patients on effective therapy with undetectable viral load are eligible
- Hepatitis B infection must be controlled with undetectable viral load if treated
- Hepatitis C infection must be cured or have undetectable viral load if currently treated
- Use of effective contraception by women of childbearing potential and men during the study and for 4 months after
- Ability to understand and sign informed consent
- Ability to swallow pills
You will not qualify if you...
- Receiving any other investigational drugs
- History of thrombectomy, caval filter placement, or need for fibrinolytic agents
- Severe clot burden such as bilateral proximal lower limb deep vein thrombosis or saddle pulmonary embolism with hemodynamic compromise
- Acute myeloid leukemia, myelodysplastic syndrome, or history of allogeneic stem cell transplant
- Luminal gastrointestinal or genitourinary cancers
- Known or prior brain metastases
- Allergy to apixaban or similar compounds
- Taking medications that affect CYP3A or P-glycoprotein
- Use of aspirin over 100 mg/day, dual antiplatelet therapy, or chronic NSAIDs
- Uncontrolled illnesses
- High risk of bleeding including unresected GI or genitourinary cancers, active gastric or duodenal cancer, recent major bleeding, prior intracranial hemorrhage, or ongoing disseminated intravascular coagulation
- Severe kidney or liver disease
- Planned major surgery during the study
- Psychiatric or social issues limiting study compliance
- Pregnancy or breastfeeding
- Unable to swallow pills
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants take dose-adjusted apixaban by mouth twice daily as treatment for cancer-associated blood clots with thrombocytopenia.
In-clinic visits with blood tests during treatment
Duration - 6 weeks
Participants are followed for safety and health assessments after stopping apixaban treatment.
2 visits: one at 7 days off treatment and one at 6 weeks off treatment
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
R
Rushad Patell, MD
F
Fernanda De Queiroz Silva, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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