Pharmacologic profile of direct oral anticoagulants in patients receiving Rituximab-CHOP chemotherapy
- Conditions
- ewly diagnosed non-Hodgkin lymphoma,diffuse large B-cell lymphoma subtype,and who are planned to be treat with R-CHOP chemotherapy regimen
- Registration Number
- TCTR20200824001
- Lead Sponsor
- Faculty of medicine Chiang Mai university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 26
1.Provided informed consent
2.Age ≥ 18 years
3.Body mass index (BMI) of 18.5-29.9 kg/m2
4.Newly diagnosed non-Hodgkin lymphoma, diffuse large B-cell lymphoma subtype, and who are planned to be treat with R-CHOP chemotherapy regimen
5.Khorana score of 2 or higher
1.Patients who are known to have significant liver disease or dysfunction (AST or ALT > 3 times ULN, Total bilirubin greater than > 2 times ULN). Examples of significant liver disease include acute clinical hepatitis, chronic active hepatitis, or cirrhosis
2.Patients who have severe renal impairment, defined as calculated creatinine clearance (CrCl) less than 30 mL/min
3.Patients who have significant respiratory, cardiovascular, metabolic, endocrine or neurologic disorders
4.Patients who have uncorrected mucosal lesions
5.Patients who have central nervous system involvement of lymphoma
6.Patients who have high disease burden, tumor lysis syndrome or those who require emergency radiation therapy
7.Patients who have poor performance status, evaluated by the Eastern Cooperative Oncology Group (ECOG) performance status equal or greater than 3
8.Patients who recently have surgery within 30 days of the enrollment
9.Patients who recently have major bleeding within 90 days of the enrollment
10.Patients with history of intracranial bleeding
11.Patients who concurrently treated with anticoagulants (LMWH, DOAC or warfarin) or antiplatelets
12.Patients who are pregnant or lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of rivaroxaban and dabigatran comparing before and after participant receiving R-CHOP chemotherapy Coagulation test
- Secondary Outcome Measures
Name Time Method Emax, time of Emax, half-life of rivaroxaban and dabigatran associated with a terminal slope (T1/2) comparing before and after participant receiving R-CHOP chemotherapy Coagulation test