NCT03282643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.4 years

First QC Date

September 12, 2017

Last Update Submit

April 15, 2019

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    4 weeks

Study Arms (3)

Rivaroxaban 10mg daily

EXPERIMENTAL

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

Drug: Rivaroxaban 10 MG

Rivaroxaban 20mg daily

EXPERIMENTAL

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

Drug: Rivaroxaban 20 MG

Low-molecular-weight heparin

ACTIVE COMPARATOR

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

Drug: Low-molecular-weight heparin

Interventions

Rivaroxaban 10 MGDRUG

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

Rivaroxaban 10mg daily
Rivaroxaban 20 MGDRUG

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

Rivaroxaban 20mg daily
Low-molecular-weight heparinDRUG

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

Low-molecular-weight heparin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital

Beijing, 100038, China

Location

Related Publications (1)

  • 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.

    PMID: 30903459DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

RivaroxabanHeparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean & Director

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

February 16, 2016

Primary Completion

June 30, 2018

Study Completion

April 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)