ADAPTiON: Apixaban Dose Adjustment in Patient With Thrombocytopenia in ONcology

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes. The name of the study drug involved in this study is: -Apixiban (a type of anticoagulant)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Active malignancy defined as histologically confirmed diagnosis within last 6 months or received any cancer directed therapy within the last 6 months.

• Radiologically confirmed newly diagnosed symptomatic deep vein thrombosis or pulmonary embolism within 28 days of enrollment. Includes proximal lower-limb DVT or symptomatic PE. Upper extremity or catheter-associated thrombosis will be included, as will distal lower extremity DVTs.

• Platelet count \< 75,000/ml (prior to platelet transfusion) within 28 days of VTE diagnosis.

• Platelet count responsive to transfusion if previously administered (defined as an average platelet increase of at least 10,000/ml over the last 3 transfusions.

• No evidence of active hemorrhage.

• No recent history of major hemorrhage (requiring transfusion, hospitalization or intervention) within the last 12 months.

• No known brain metastases.

• Age ≥18 years. Because no dosing or adverse event data are currently available on the use of apixaban in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.

• ECOG performance status ≤2

• Participants must have adequate organ and marrow function as defined below:

‣ Total bilirubin ≤ institutional upper limit of normal (ULN)

⁃ AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN

⁃ Glomerular filtration rate (GFR) ≥25 mL/min/1.73/m2

• Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

• For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

• Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

• The effects of apixaban on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of apixaban administration.

• Ability to understand and the willingness to sign a written informed consent document.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Rushad Patell, MD
rpatell@bidmc.harvard.edu
617-667-9179
Backup
Fernanda De Queiroz Silva, MD
fdequeir@bidmc.harvard.edu
617-667-9920
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 30
Treatments
Experimental: DOSE-ADJUSTED APIXABAN
30 enrolled participants will complete study procedures as follows:~* Baseline visit with assessments~* Predetermined dose of Apixiban 2x daily for 90 days~* Off treatment visit 7 days after last study drug dose~* Follow up visit 6 weeks after last study drug dose
Sponsors
Leads: Rushad Patell

This content was sourced from clinicaltrials.gov