Newly diagnosed non-
Conditions
Interventions
Participants will be instructed to take rivaroxaban one day prior to initiating R-
CHOP chemotherapy and right before starting R-
CHOP on the day giving R-
CHOP,Participants will be instructed to take the dabigatran one day prior to initiating R-
CHOP
Experimental Drug,Experimental Drug
Rivaroxaban,Dabigatran
Sponsors
Faculty of medicine Chiang Mai university
Thai Society of Hematology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of rivaroxaban and dabigatran comparing before and after participant receiving R-CHOP chemotherapy Coagulation test | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactTeerachat Punnachet
Division of hematology, department of internal medicine
Outcome results
None listed