LymphomaPhase 2NCT00490009
Phase 2 Study of Bexxar in Relapsed/Refractory DLCL
A Phase 2 study testing Bexxar, Acetaminophen and Diphenhydramine in people with Lymphoma, run by Susan Knox at 1 site in United States.
Trial summary
The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Bexxar, Acetaminophen and Diphenhydramine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed, diffuse large cell lymphoma (DLCL), CD20+ B-cell non-Hodgkin lymphoma (NHL) who have relapsed after chemotherapy or are chemotherapy resistant, without prior history of low grade NHL. The patient must have failed at least one chemotherapy regimen containing an anthracycline or equivalent chemotherapeutic agent.
- No anticancer treatment for three weeks prior to the treatment dose of Bexxar (6 weeks if Rituximab, nitrosourea or Mitomycin C)
- Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
- An Institutional Review Board (IRB)-approved signed informed consent
- Age 19 years or older
- Prestudy Karnofsky Performance Status of ≥ 70%
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- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hct > 30%
- Hgb > 9.0 gm%
- Bilirubin ≤ 2.0
- Creatinine ≤ 2.0
- Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment
- Acceptable birth control method for men and women
- Female patients who are not pregnant
- Not lactating
Who cannot join
- Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
- Platelet count < 100,000/mm³
- Hypocellular bone marrow (≤ 15% cellularity)
- Marked reduction in bone marrow precursors of one or more cell lines
- History of failed stem cell collection
- Prior treatment with Fludarabine
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- Prior radioimmunotherapy
- Presence of central nervous system (CNS) lymphoma
- Patients with known HIV or AIDS-related lymphoma
- Patients with evidence of myelodysplasia on bone marrow biopsy
- Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow
- Patients who have received filgrastim or sargramostim therapy within 3 weeks prior to treatment
- Pregnant
- Lactating
- Presence of human anti-mouse antibody (HAMA) reactivity in patients with prior exposure to murine antibodies or proteins
- Serious nonmalignant disease or infection, which, in the opinion of the investigator, would compromise other protocol objectives
- Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate specific antigen levels) for which the patients has not been disease-free for at least 3 years
- Major surgery, other than diagnostic surgery, within 4 weeks
- Patients with pleural effusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)
The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).
Read the detailed description
There is a lack of efficacious treatment options for patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL) who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population.
This study evaluated if Bexxar is safe and efficacious for diffuse large cell Non-Hodgkin's lymphoma.
- Conditions
- Lymphoma
- Being tested
- Bexxar, Acetaminophen, Diphenhydramine, Potassium Iodide (KI)
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BexxarDrug
Also called Tositumomab, iodine-131 tositumomab, I-131 tositumomab
Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells.
Bexxar will be administered to provide the following patient-specific radiotherapy:
- Platelet count of 150,000/mm³ = 75 cGy
- Platelet count ≥ 100,000/mm³ but < 150,000/mm³ = 65 cGy
AcetaminophenDrug
Also called Tylenol
As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain
DiphenhydramineDrug
Also called Benadryl
As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions
Potassium Iodide (KI)Drug
Also called Saturated solution potassium iodine (SSKI), Lugol's solution
Administered to prevent thyroid blockage 130 mg orally 3 times a day,
| Study group | Role | What they receive |
|---|---|---|
| Bexxar + Total Body Irradiation (TBI) | Experimental | Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI). Receives: Drug: Bexxar; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Potassium Iodide (KI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Rate
Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.
Measured: 6 years
Secondary outcomes (2)
Time to Progression (TTP)
Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.
Measured: 1.5 months; 3 months; 6 months; or Not Progressed
Overall Survival (OS) Rate
Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startSep 2004
- Primary completionApr 2010
- Study completionJun 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.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susan Knox
- Sponsor type
- University, hospital or other
- Collaborators
- Corixa Corporation, GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Susan Knox, Stanford University
- Investigators
- Susan J Knox, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490009
- Sponsor's protocol ID
- IRB-10275
- Other IDs
- LYMNHL0019, 30978
- Status last verified
- Feb 2017
- First submitted
- 20 Jun 2007
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)
- ClinicalTrials.gov ID
- NCT00490009
- Acronym / sponsor ID
- IRB-10275
- Conditions
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Susan KnoxUniversity, hospital or other
- Collaborators
- Corixa Corporation, GlaxoSmithKline
- Study start
- Sep 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Jun 2007 (estimated)
- Results
- Posted 28 Feb 2017
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 obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).
Detailed description
There is a lack of efficacious treatment options for patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL) who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population.
This study evaluated if Bexxar is safe and efficacious for diffuse large cell Non-Hodgkin's lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bexxar + Total Body Irradiation (TBI) | Experimental | Drug: Bexxar, Drug: Acetaminophen, Drug: Diphenhydramine, Drug: Potassium Iodide (KI)Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically-confirmed, diffuse large cell lymphoma (DLCL), CD20+ B-cell non-Hodgkin lymphoma (NHL) who have relapsed after chemotherapy or are chemotherapy resistant, without prior history of low grade NHL. The patient must have failed at least one chemotherapy regimen containing an anthracycline or equivalent chemotherapeutic agent.
- No anticancer treatment for three weeks prior to the treatment dose of Bexxar (6 weeks if Rituximab, nitrosourea or Mitomycin C)
- Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
- An Institutional Review Board (IRB)-approved signed informed consent
- Age 19 years or older
Key exclusion criteria (19 listed)
- Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
- Platelet count < 100,000/mm³
- Hypocellular bone marrow (≤ 15% cellularity)
- Marked reduction in bone marrow precursors of one or more cell lines
- History of failed stem cell collection
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 |
|---|---|---|
| BexxarAlso: Tositumomab, iodine-131 tositumomab, I-131 tositumomabBexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells. Bexxar will be administered to provide the following patient-specific radiotherapy: * Platelet count of 150,000/mm³ = 75 cGy * Platelet count ≥ 100,000/mm³ but < 150,000/mm³ = 65 cGy | Drug | Bexxar + Total Body Irradiation (TBI) |
| AcetaminophenAlso: TylenolAs premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain | Drug | Bexxar + Total Body Irradiation (TBI) |
| DiphenhydramineAlso: BenadrylAs premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions | Drug | Bexxar + Total Body Irradiation (TBI) |
| Potassium Iodide (KI)Also: Saturated solution potassium iodine (SSKI), Lugol's solutionAdministered to prevent thyroid blockage 130 mg orally 3 times a day, | Drug | Bexxar + Total Body Irradiation (TBI) |
Primary outcome
Clinical Response Rate
Time frame: 6 years
Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.
2 secondary outcomes
Time to Progression (TTP)
Time frame: 1.5 months; 3 months; 6 months; or Not Progressed
Overall Survival (OS) Rate
Time frame: 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Susan J Knox principal investigator
Stanford 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 Bexxar, Acetaminophen and Diphenhydramine in people with Lymphoma, run by Susan Knox 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 16 inclusion and 19 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 30 Mar 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 28 Feb 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?
Clinical Response Rate (time frame: 6 years). 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 30 Mar 2017.