Indolent or Intermediate Grade B-cell MalignancyPhase 2NCT01206777
Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies
A Phase 2 study testing Rituximab in people with Indolent or Intermediate Grade B-cell Malignancy, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility of a 60 minute rapid infusion rituximab protocol in the institution's outpatient infusion center. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Indolent or Intermediate Grade B-cell Malignancy
- What is being tested?
- Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89
- Diagnosis of indolent or intermediate grade B-cell malignancy
- Patients receiving rituximab-based therapy at a dose of 375mg/m2, regardless of weight
- First dose given within 3 months of the second dose
- Infusion scheduled for outpatient administration at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Who cannot join
- Diagnosis of aggressive lymphoma
- Absolute lymphocyte count > 10 x 103 cells/µL
- New York Heart Association (NYHA) classification Grade II or greater congestive heart failure
- Enrolled on another clinical trial
- Allergy to murine-containing medications
- Grade III or IV hypersensitivity reaction during the initial infusion of rituximab
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- Prisoners
- Pregnant women
- Mentally or physically unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Assessment of Hypersensitivity Reactions and Feasibility of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) at a Comprehensive Cancer Center
The purpose of this study is to assess the feasibility of a 60 minute rapid infusion rituximab protocol in the institution's outpatient infusion center.
- Being tested
- Rituximab
- Keywords
- Hypersensitivity Reactions, B-cell malignancies
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade III and IV Hypersensitivity Reactions
Measured: Every 15 minutes from start of infusion until completion, for up to 1 hour
Secondary outcomes (2)
Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule
Measured: Determined from difference in expected time by package insert administration and actual time on day of treatment
Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice
Surveys were given to nurses in the outpatient infusion center to measure their satisfaction with the administration of the rapid infusion rate compared to standard titration practice.
Measured: 6 months, as a before and after infusion survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Indolent or Intermediate Grade B-cell MalignancyStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Jones, M.D., M.P.H., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206777
- Sponsor's protocol ID
- OSU-10001
- Other IDs
- NCI-2012-00929
- Status last verified
- Dec 2017
- First submitted
- 10 Sep 2010
- Last updated
- 20 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dotson E, Crawford B, Phillips G, Jones J. Sixty-minute infusion rituximab protocol allows for safe and efficient workflow. Support Care Cancer. 2016 Mar;24(3):1125-9. doi: 10.1007/s00520-015-2869-4. Epub 2015 Aug 14.
PubMed 26268782
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hypersensitivity Reactions and Feasibility of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) at a Comprehensive Cancer Center
- ClinicalTrials.gov ID
- NCT01206777
- Acronym / sponsor ID
- OSU-10001
- Keywords
- Hypersensitivity Reactions, B-cell malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility of a 60 minute rapid infusion rituximab protocol in the institution's outpatient infusion center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-89
- Diagnosis of indolent or intermediate grade B-cell malignancy
- Patients receiving rituximab-based therapy at a dose of 375mg/m2, regardless of weight
- First dose given within 3 months of the second dose
- Infusion scheduled for outpatient administration at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Key exclusion criteria (9 listed)
- Diagnosis of aggressive lymphoma
- Absolute lymphocyte count > 10 x 103 cells/µL
- New York Heart Association (NYHA) classification Grade II or greater congestive heart failure
- Enrolled on another clinical trial
- Allergy to murine-containing medications
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 |
|---|---|---|
| RituximabDose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes. | Drug | Rituximab |
Primary outcome
Incidence of Grade III and IV Hypersensitivity Reactions
Time frame: Every 15 minutes from start of infusion until completion, for up to 1 hour
2 secondary outcomes
Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule
Time frame: Determined from difference in expected time by package insert administration and actual time on day of treatment
Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice
Time frame: 6 months, as a before and after infusion survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26268782Dotson E, Crawford B, Phillips G, Jones J. Sixty-minute infusion rituximab protocol allows for safe and efficient workflow. Support Care Cancer. 2016 Mar;24(3):1125-9. doi: 10.1007/s00520-015-2869-4. Epub 2015 Aug 14.
- JameslineLink provided by the sponsor.
Related trials for Indolent or Intermediate Grade B-cell Malignancy
Active, not recruitingPhase 2
Nivolumab With DA-REPOCH Chemotherapy Regimen in Treating Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma
Aggressive Non-Hodgkin Lymphoma, Ann Arbor Stage I Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
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.
Jeffrey Jones, M.D., M.P.H. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with Indolent or Intermediate Grade B-cell Malignancy, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 5 inclusion and 9 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 20 Dec 2017. 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 United States. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Grade III and IV Hypersensitivity Reactions (time frame: Every 15 minutes from start of infusion until completion, for up to 1 hour). 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 NCT01206777, 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 20 Dec 2017.