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

Primary Purpose

Neoplasms

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Rivaroxaban 10 MG

Rivaroxaban 20 MG

Low-molecular-weight heparin

About this trial

This is an interventional prevention trial for Neoplasms

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.;

Sites / Locations

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Rivaroxaban 10mg daily

Rivaroxaban 20mg daily

Low-molecular-weight heparin

Arm Description

orally, 10 mg once daily for day1 and day 2 after femoral venepuncture

orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture

subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0

Full Information

NCT ID

NCT03282643

First Posted

September 12, 2017

Last Updated

April 15, 2019

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03282643

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

February 16, 2016 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rivaroxaban 10mg daily

Arm Type

Experimental

Arm Description

orally, 10 mg once daily for day1 and day 2 after femoral venepuncture

Arm Title

Rivaroxaban 20mg daily

Arm Type

Experimental

Arm Description

orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture

Arm Title

Low-molecular-weight heparin

Arm Type

Active Comparator

Arm Description

subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2)

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban 10 MG

Intervention Description

Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban 20 MG

Intervention Description

Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture

Intervention Type

Drug

Intervention Name(s)

Low-molecular-weight heparin

Intervention Description

0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)

Primary Outcome Measure Information:

Title

Incidence rate of deep venous thrombosis

Description

the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.;

Facility Information:

Facility Name

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

City

Beijing

ZIP/Postal Code

100038

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30903459

Citation

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.

Results Reference

derived

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

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