NeoplasmsPhase 1/2NCT03282643
Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients
A Phase 1/2 study testing Rivaroxaban 10 MG, Rivaroxaban 20 MG and Low-molecular-weight heparin in people with Neoplasms, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Rivaroxaban 10 MG, Rivaroxaban 20 MG and Low-molecular-weight heparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2016to 1 Apr 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.;
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
Beijing, 100038
About this study
Official title: 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.
- Conditions
- Neoplasms
- Being tested
- Rivaroxaban 10 MG, Rivaroxaban 20 MG, Low-molecular-weight heparin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 MGDrug
Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture
Rivaroxaban 20 MGDrug
Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture
Low-molecular-weight heparinDrug
0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban 10mg daily | Experimental | orally, 10 mg once daily for day1 and day 2 after femoral venepuncture Receives: Drug: Rivaroxaban 10 MG |
| Rivaroxaban 20mg daily | Experimental | orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture Receives: 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) Receives: Drug: Low-molecular-weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start16 Feb 2016
- Primary completion30 Jun 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ren MD, PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282643
- Sponsor's protocol ID
- Rivaroxaban vs heparin
- Status last verified
- Apr 2019
- First submitted
- 12 Sep 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30903459
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture
- ClinicalTrials.gov ID
- NCT03282643
- Acronym / sponsor ID
- Rivaroxaban vs heparin
- Conditions
- Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban 10mg daily | Experimental | Drug: Rivaroxaban 10 MGorally, 10 mg once daily for day1 and day 2 after femoral venepuncture |
| Rivaroxaban 20mg daily | Experimental | Drug: Rivaroxaban 20 MGorally, 10 mg twice daily for day1 and day 2 after femoral venepuncture |
| Low-molecular-weight heparin | Active comparator | Drug: Low-molecular-weight heparinsubcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 10 MGRivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture | Drug | Rivaroxaban 10mg daily |
| Rivaroxaban 20 MGRivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture | Drug | Rivaroxaban 20mg daily |
| Low-molecular-weight heparin0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2) | Drug | Low-molecular-weight heparin |
Primary outcome
Incidence rate of deep venous thrombosis
Time frame: 4 weeks
the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 30903459Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rivaroxaban 10 MG, Rivaroxaban 20 MG and Low-molecular-weight heparin in people with Neoplasms, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of deep venous thrombosis (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.