Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients

Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture

The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among cancer patients.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: Rivaroxaban 10 MG; Drug: Rivaroxaban 20 MG; Drug: Low-molecular-weight heparin

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100038
    • Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 to 85
• Histologically or cytologically confirmed advanced or metastatic solid tumors
• Patients will be received femoral venepuncture for apheresis by cell separator, which is the necessary process to perform following adoptive cell immunotherapy.
• Estimated life expectancy > 3 months
• Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR <1.5 (unless patient is receiving warfarin in which case PT-INR must be <3), PTT <1.5X ULN
• Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.

Exclusion Criteria:

• known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis
• Platelet count < 50 000 G/L
• Active bleeding
• Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
• Patients with obstructive jaundice
• Patients with Spleen hyperfunction
• Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
• Pregnant or breast-feeding women，or lack of effective contraceptive treatment for women of childbearing age.;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivaroxaban 10mg daily; orally, 10 mg once daily for day1 and day 2 after femoral venepuncture	Drug: Rivaroxaban 10 MG; Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture
Experimental: Rivaroxaban 20mg daily; orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture	Drug: Rivaroxaban 20 MG; Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture
Active Comparator: Low-molecular-weight heparin; subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)	Drug: Low-molecular-weight heparin; 0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of deep venous thrombosis	the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0	4 weeks

Collaborators and Investigators

• Sponsor: Capital Medical University

Publications and helpful links

General Publications

• Wang X, Wang S, Morse MA, Jiang N, Zhao Y, Song Y, Zhou L, Huang H, Zhou X, Hobeika A, Ren J, Lyerly HK. Prospective randomized comparative study on rivaroxaban and LMWH for prophylaxis of post-apheresis thrombosis in adoptive T cell immunotherapy cancer patients. J Thromb Thrombolysis. 2019 May;47(4):505-511. doi: 10.1007/s11239-019-01844-7.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: Rivaroxaban vs heparin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No