Lymphoproliferative DisorderPhase 2NCT00869323
Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders
A Phase 2 study testing rituximab and bortezomib in people with Lymphoproliferative Disorder, run by Masonic Cancer Center, University of Minnesota at 2 sites in United States.
Trial summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoproliferative Disorder
- What is being tested?
- rituximab and bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Dec 2016
- 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
- Histologically confirmed CD20+ B-cell post-transplant lymphoproliferative disorder
- Has undergone prior solid organ transplant
- Measurable disease as defined by Non-Hodgkin Lymphoma Response Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) ≥ 1,000/mm³
- Platelet count ≥ 75,000/mm³
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- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min
- Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal
- Total bilirubin ≤ 2.0 mg/dL
Who cannot join
- Pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Peripheral neuropathy ≥ grade 2
- Known lymphomatous meningitis or central nervous system (CNS) involvement
- HIV infection
- Uncontrolled infection
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- Myocardial infarction within the past 6 months or uncontrolled angina
- New York Heart Association class III-IV heart failure
- Severe uncontrolled ventricular arrhythmias
- Evidence of acute ischemia or active conduction system abnormalities by electrocardiogram (EKG)
- Concurrent serious medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
- Diagnosis or treatment for another malignancy within the past 3 years, except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy, or curatively treated low-risk prostate cancer
- Known hypersensitivity to rituximab, bortezomib, boron, or any of the other agents used in this study
- Less than 14 days since prior investigational drugs
- Less than 4 weeks since prior bortezomib therapy (12 weeks for rituximab) and recovered from toxic effects prior to enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota Medical Center - Fairview
Minneapolis, Minnesota, 55455
Washington University School of Medicine - Oncology Division
St Louis, Missouri, 63110
About this study
Official title: Phase II Trial of Bortezomib and Rituximab for Patients With Post Transplant Lymphoproliferative Disorders (PTLD)
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with post-transplant lymphoproliferative disorders.
Read the detailed description
OBJECTIVES:
Primary
- To estimate the overall (complete and partial) response rates in patients with CD20+ post-transplant lymphoproliferative disorders treated with bortezomib and rituximab.
Secondary
- To evaluate the duration of remission, time to treatment failure, relapse-free survival, and overall survival of these patients.
- To characterize the quantitative and qualitative toxicities of this regimen.
OUTLINE:
- Induction therapy: Patients receive bortezomib intravenously (IV) and rituximab IV on days 1, 8, 15, and 22.
Patients achieving complete remission (CR) after completion of induction therapy proceed to maintenance therapy after 6 months of rest. Patients achieving partial remission (PR) or stable disease after completion of induction therapy receive additional bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/PR after completion of bortezomib therapy proceed to maintenance therapy after 3 months of rest.
- Maintenance therapy: Patients receive bortezomib IV and rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
- Conditions
- Lymphoproliferative Disorder
- Being tested
- rituximab, bortezomib
- Keywords
- post-transplant lymphoproliferative disorder
- Medical subject headings
- Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Also called Rituxan
375 mg/m^2 intravenously on Days 1,8, 15 and 22
bortezomibDrug
Also called Velcade
1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22
| Study group | Role | What they receive |
|---|---|---|
| Treated Patients | Experimental | This group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD). Receives: Biological: rituximab; Drug: bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Overall (Complete and Partial) Response Rates
Measured: Day 1 to 2 Years Post Treatment
Secondary outcomes (4)
Remission Duration Among Patients Who Respond to Treatment
Measured: Day 1 to 8 Months Post Treatment
Time to Treatment Failure
Measured: Day 1 to Time of Disease Progression
Relapse-free Survival
Measured: at 2 years
Overall Survival
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2013
- Study completionDec 2016
Why it stopped: Funding unavailable
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.
- Other trials for Lymphoproliferative DisorderStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Anne H. Blaes, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869323
- Sponsor's protocol ID
- 2008LS043
- Other IDs
- MT2008-05R, 0806M37121
- Status last verified
- Dec 2017
- First submitted
- 25 Mar 2009
- Last updated
- 5 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Bortezomib and Rituximab for Patients With Post Transplant Lymphoproliferative Disorders (PTLD)
- ClinicalTrials.gov ID
- NCT00869323
- Acronym / sponsor ID
- 2008LS043
- Conditions
- Lymphoproliferative Disorder
- Keywords
- post-transplant lymphoproliferative disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Mar 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with post-transplant lymphoproliferative disorders.
Detailed description
OBJECTIVES:
Primary
- To estimate the overall (complete and partial) response rates in patients with CD20+ post-transplant lymphoproliferative disorders treated with bortezomib and rituximab.
Secondary
- To evaluate the duration of remission, time to treatment failure, relapse-free survival, and overall survival of these patients.
- To characterize the quantitative and qualitative toxicities of this regimen.
OUTLINE:
- Induction therapy: Patients receive bortezomib intravenously (IV) and rituximab IV on days 1, 8, 15, and 22.
Patients achieving complete remission (CR) after completion of induction therapy proceed to maintenance therapy after 6 months of rest. Patients achieving partial remission (PR) or stable disease after completion of induction therapy receive additional bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR/PR after completion of bortezomib therapy proceed to maintenance therapy after 3 months of rest.
- Maintenance therapy: Patients receive bortezomib IV and rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Patients | Experimental | Biological: rituximab, Drug: bortezomibThis group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed CD20+ B-cell post-transplant lymphoproliferative disorder
- Has undergone prior solid organ transplant
- Measurable disease as defined by Non-Hodgkin Lymphoma Response Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) ≥ 1,000/mm³
Key exclusion criteria (15 listed)
- Pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Peripheral neuropathy ≥ grade 2
- Known lymphomatous meningitis or central nervous system (CNS) involvement
- HIV infection
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 |
|---|---|---|
| rituximabAlso: Rituxan375 mg/m^2 intravenously on Days 1,8, 15 and 22 | Biological | Treated Patients |
| bortezomibAlso: Velcade1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 | Drug | Treated Patients |
Primary outcome
Number of Patients With Overall (Complete and Partial) Response Rates
Time frame: Day 1 to 2 Years Post Treatment
4 secondary outcomes
Remission Duration Among Patients Who Respond to Treatment
Time frame: Day 1 to 8 Months Post Treatment
Time to Treatment Failure
Time frame: Day 1 to Time of Disease Progression
Relapse-free Survival
Time frame: at 2 years
Overall Survival
Time frame: at 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anne H. Blaes, MD principal investigator
Masonic Cancer Center, University of Minnesota
2 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 rituximab and bortezomib in people with Lymphoproliferative Disorder, run by Masonic Cancer Center, University of Minnesota at 2 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 5 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 2 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 5 Apr 2017). 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 Patients With Overall (Complete and Partial) Response Rates (time frame: Day 1 to 2 Years Post Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2017.