Non-Hodgkin's LymphomaPhase 2BVRNCT00547534
Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma
A Phase 2 study testing bortezomib, bendamustine and rituximab in people with Non-Hodgkin's Lymphoma, run by University of Rochester at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- bortezomib, bendamustine and rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2007to Oct 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent before performance of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use acceptable method of birth control for duration of study.
- Male subject agrees to use acceptable method for contraception for duration of study.
- Histologically-confirmed indolent or mantle cell lymphoma, utilizing the World Health Organization (WHO) classification. The biopsy must fulfill one of the following criteria:
- Follicular lymphoma, grades 1-3
- Marginal zone lymphoma
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- Small lymphocytic lymphoma (circulating lymphocyte count must be < 5,000)
- Lymphoplasmacytic lymphoma
- Mantle cell lymphoma [confirmed by cyclin D1+ or FISH for t(11;14)]
- Age ≥ 18 years
- Must have received at least one prior chemotherapy regimen for lymphoma. Patients treated only with antibody therapy or only with radiation therapy are not eligible.
- Zubrod performance status ≤ 3
- Patients must have measurable disease or an indication to receive additional therapy
Who cannot join
- Patient has platelet count of ≤75,000/mm^3 within 14 days before enrollment.
- Patient has absolute neutrophil count of < 1,000/mm^3 within 14 days before enrollment.
- Patient has calculated or measured creatinine clearance of <30 mL/minute within 14 days before enrollment.
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to boron or mannitol
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- Female subject is pregnant or breast-feeding. Confirmation subject is not pregnant must be established by negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received chemotherapy or antibody therapy within 28 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Patient has received other investigational drugs with 14 days before enrollment
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Prior exposure to bendamustine
- Prior exposure to bortezomib if Time to Progression (TTP) after bortezomib containing regimen was < 6 months. If TTP after bortezomib containing regimen was > 6 months, then patient is allowed to enroll on the study.
- Patient has concomitant active malignancy requiring therapy
- Patient is known to be HIV positive (test result not required for enrollment).
- History of solid organ transplantation, or post transplant lymphoproliferative disorder
- Patient has history of allogeneic stem cell transplantation.
- Patient has history of autologous stem cell transplantation or radioimmunotherapy within the previous 4 months.
- Patient has received any other investigational drugs within 14 days prior to enrollment
- History of, or clinically apparent CNS lymphoma
- Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis results that, in the judgment of the investigator, would impede adequate evaluation of adverse events and/or response to treatment, or that requires aggressive intervention
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cornell Wiell Medical College
New York, New York, 10021
Nebraska Medical Center
Omaha, Nebraska, 68198
University of Rochester Medical Center (James P. Wilmot Cancer Center)
Rochester, New York, 14642
About this study
Official title: Pilot Study of Bortezomib, Bendamustine and Rituximab for Patients With Relapsed or Refractory, Indolent or Mantle Cell Non-Hodgkin's Lymphoma
The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- bortezomib, bendamustine, rituximab
- Keywords
- Bortezomib, Bendamustine, Rituximab, Relapsed, Refractory, Mantle Cell, Indolent
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Also called Velcade
1.3 mg/m^2 on days 1, 4, 8, 11
bendamustineDrug
Also called Treanda
90 mg/m^2 days 1 and 4
rituximabDrug
Also called Rituxan
375 mg/m^2 day 1
| Study group | Role | What they receive |
|---|---|---|
| Lymphoma Subjects receiving protocol therapy | Experimental | Subjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib. Receives: Drug: bortezomib; Drug: bendamustine; Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression Free Survival at 2 Years
To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.
Measured: Two years
Secondary outcomes (2)
Toxicity of Drug Combination in the Subjects
Measured: Two years
Overall Response Rate (ORR)
Overall response rate (ORR)to protocol treatment - Partial response, Complete response, etc.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2009
- Study completionOct 2009
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 Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Cephalon
- Responsible party
- Principal investigator, Jonathan Friedberg, University of Rochester
- Investigators
- Jonathan Friedberg, md, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547534
- Sponsor's protocol ID
- ULYM07054
- Acronym
- BVR
- Status last verified
- Jul 2015
- First submitted
- 18 Oct 2007
- Last updated
- 6 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Friedberg JW, Vose JM, Kelly JL, Young F, Bernstein SH, Peterson D, Rich L, Blumel S, Proia NK, Liesveld J, Fisher RI, Armitage JO, Grant S, Leonard JP. The combination of bendamustine, bortezomib, and rituximab for patients with relapsed/refractory indolent and mantle cell non-Hodgkin lymphoma. Blood. 2011 Mar 10;117(10):2807-12. doi: 10.1182/blood-2010-11-314708. Epub 2011 Jan 14.
PubMed 21239695
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Bortezomib, Bendamustine and Rituximab for Patients With Relapsed or Refractory, Indolent or Mantle Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00547534
- Acronym / sponsor ID
- BVR / ULYM07054
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Bortezomib, Bendamustine, Rituximab, Relapsed, Refractory, Mantle Cell, Indolent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Cephalon
- Study start
- Oct 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Oct 2007 (estimated)
- Results
- Posted 6 Jun 2011
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 evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoma Subjects receiving protocol therapy | Experimental | Drug: bortezomib, Drug: bendamustine, Drug: rituximabSubjects that met all eligibility criteria and were treated with Bendamustine, Rituxan and Bortezomib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntary written informed consent before performance of any study-specific procedure not part of routine medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Female subject is either post-menopausal or surgically sterilized or willing to use acceptable method of birth control for duration of study.
- Male subject agrees to use acceptable method for contraception for duration of study.
- Histologically-confirmed indolent or mantle cell lymphoma, utilizing the World Health Organization (WHO) classification. The biopsy must fulfill one of the following criteria:
- Age ≥ 18 years
Key exclusion criteria (21 listed)
- Patient has platelet count of ≤75,000/mm^3 within 14 days before enrollment.
- Patient has absolute neutrophil count of < 1,000/mm^3 within 14 days before enrollment.
- Patient has calculated or measured creatinine clearance of <30 mL/minute within 14 days before enrollment.
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
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 |
|---|---|---|
| bortezomibAlso: Velcade1.3 mg/m^2 on days 1, 4, 8, 11 | Drug | Lymphoma Subjects receiving protocol therapy |
| bendamustineAlso: Treanda90 mg/m^2 days 1 and 4 | Drug | Lymphoma Subjects receiving protocol therapy |
| rituximabAlso: Rituxan375 mg/m^2 day 1 | Drug | Lymphoma Subjects receiving protocol therapy |
Primary outcome
Number of Participants With Progression Free Survival at 2 Years
Time frame: Two years
To determine the progression-free survival following treatment with the BVR combination in patients with relapsed or refractory indolent and mantle cell non-Hodgkin lymphoma.
2 secondary outcomes
Toxicity of Drug Combination in the Subjects
Time frame: Two years
Overall Response Rate (ORR)
Time frame: Two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21239695Friedberg JW, Vose JM, Kelly JL, Young F, Bernstein SH, Peterson D, Rich L, Blumel S, Proia NK, Liesveld J, Fisher RI, Armitage JO, Grant S, Leonard JP. The combination of bendamustine, bortezomib, and rituximab for patients with relapsed/refractory indolent and mantle cell non-Hodgkin lymphoma. Blood. 2011 Mar 10;117(10):2807-12. doi: 10.1182/blood-2010-11-314708. Epub 2011 Jan 14.
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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.
Jonathan Friedberg, md principal investigator
University of Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib, bendamustine and rituximab in people with Non-Hodgkin's Lymphoma, run by University of Rochester at 3 sites 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 13 inclusion and 21 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 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 6 Jun 2011). 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?
Number of Participants With Progression Free Survival at 2 Years (time frame: Two years). 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 NCT00547534, 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 6 Aug 2015.