Lymphoma, Small Cleaved-Cell, FollicularPhase 3NCT00319332
A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen
A Phase 3 study testing Ibritumomab Tiuxetan and Iodine I 131 Tositumomab in people with Lymphoma, Small Cleaved-Cell, Follicular and Lymphoma, Large-Cell, Follicular, run by GlaxoSmithKline at 8 sites in United States.
Trial summary
This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Small Cleaved-Cell, Follicular, Lymphoma, Large-Cell, Follicular, Lymphoma, Follicular
- What is being tested?
- Ibritumomab Tiuxetan and Iodine I 131 Tositumomab
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2005to Feb 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (WHO/REAL classification).
- International Working Formulation histological equivalents of Follicular, small cleaved; Follicular, mixed small-cleaved and large-cell; follicular large-cell; or Transformed diffuse large cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
- Patients diagnosed with diffuse large cell lymphoma at study enrollment must have a historical or contemporaneous lymph node biopsy that demonstrates a diagnosis of follicular lymphoma.
- Recurrent lymphoma after at least three qualifying therapy regimens including at least one Rituximab-containing regimen and at least one chemotherapy regimen.
- The patient must have either not responded or responded with a duration of response of less than 6 months to a Rituximab-containing regimen, Performance status of at least 70% on the Karnofsky Scale and an anticipated survival of at least three months.
- Bi-dimensionally measurable disease with at least one lesion measuring 4.0 cm2 by CT scan.
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- Absolute neutrophil count >/= 1500 cells/mm3 and platelet count >/=100,000/mm3 within 21 days prior to study enrollment.
- Blood products and/or growth factors should not be taken within 4 weeks prior to blood draw.
- Adequate renal function (defined as serum creatinine <1.5 x upper limit of normal) and adequate hepatic function (defined as total bilirubin <1.5x upper limit of normal and AST <5x upper limit of normal) within 21 days prior to study enrollment.
- Human Anti-Murine Antibody (HAMA) negative within 21 days prior to study enrollment.
- Provision of informed consent as signified by a signed IRB approved consent form prior to any study-specific procedures being implemented.
Who cannot join
- Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days prior to study enrollment.
- Hypocellular bone marrow (</=15% cellularity or marked reduction in bone marrow precursors).
- Prior myeloablative therapy.
- History of failed stem cell collection.
- Prior radiotherapy to fields encompassing more than 25% of the blood forming marrow.
- Prior chemotherapy, biologic therapy, radiation therapy or steroid therapy for NHL within eight weeks prior to screening procedures.
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- Prior radioimmunotherapy.
- Prior treatment with any non-human, particularly murine monoclonal or polyclonal antibodies for either diagnostic or therapeutic purposes. This exclusion does not extend to the chimeric monoclonal antibody, Rituximab.
- Prior malignancy other than lymphoma, except for adequately treated basal cell or squamous cell skin cancer, in situ uterine cervical cancer, or other cancer for which the patient has been disease-free for five years.
- Active infection requiring intravenous antibiotics at the time of study enrollment.
- New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
- HBsAg seropositivity.
- Known HIV infection.
- Known brain or leptomeningeal metastases.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
GSK Clinical Trials Call Center
Buffalo, New York, 14263
GSK Clinical Trials Call Center
Charleston, North Carolina, 29425
GSK Clinical Trials Call Center
Iowa City, Iowa, 52242
GSK Clinical Trial Call Center
Knoxville, Tennessee, 37920
GSK Clinical Trial Call Center
Portland, Oregon, 97213
GSK Clinical Trial Call Center
Seattle, Washington, 98109
GSK Clinical Trial Call Center
St Louis, Missouri, 63110
GSK Clinical Trials Call Center
Tacoma, Washington, 98431
About this study
Official title: A Multi-center, Randomized, Phase 3 Study of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients With Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma
This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. A total of 350 patients, approximately 175 patients per arm, will be enrolled at 30 to 40 sites in the United States.
- Conditions
- Lymphoma, Small Cleaved-Cell, Follicular, Lymphoma, Large-Cell, Follicular, Lymphoma, Follicular, Lymphoma, Non-Hodgkin
- Being tested
- Ibritumomab Tiuxetan, Iodine I 131 Tositumomab
- Keywords
- non-Hodgkin's Lymphoma, follicular lymphoma, BEXXAR, ZEVALIN, Iodine I 131 Tositumomab, Ibritumomab Tiuxetan, Follicular, mixed small-cleaved and large-cell, Diffuse large cell non-Hodgkin's lymphoma following or concurrent with a diagnosis of follicular lymphoma
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibritumomab TiuxetanDrug
Iodine I 131 TositumomabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the proportion of subjects experiencing Grade 3/4 hematological toxicity within 120 days from completion of treatment regimen administration.
Secondary outcomes (1)
The final analysis will be carried out when 130 events (progressive disease, death or subsequent therapy) have occurred in the control arm, expected approximately 18 months after last subject last visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startSep 2005
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: This study has been cancelled prior to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Small Cleaved-Cell, FollicularStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319332
- Sponsor's protocol ID
- 393229/029
- Other IDs
- CCBX001-053
- Status last verified
- Apr 2015
- First submitted
- 26 Apr 2006
- Last updated
- 17 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Phase 3 Study of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients With Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00319332
- Acronym / sponsor ID
- 393229/029
- Conditions
- Lymphoma, Small Cleaved-Cell, Follicular, Lymphoma, Large-Cell, Follicular, Lymphoma, Follicular, Lymphoma, Non-Hodgkin
- Keywords
- non-Hodgkin's Lymphoma, follicular lymphoma, BEXXAR, ZEVALIN, Iodine I 131 Tositumomab, Ibritumomab Tiuxetan, Follicular, mixed small-cleaved and large-cell, Diffuse large cell non-Hodgkin's lymphoma following or concurrent with a diagnosis of follicular lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been cancelled prior to enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 27 Apr 2006 (estimated)
- 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.
This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. A total of 350 patients, approximately 175 patients per arm, will be enrolled at 30 to 40 sites in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (WHO/REAL classification).
- International Working Formulation histological equivalents of Follicular, small cleaved; Follicular, mixed small-cleaved and large-cell; follicular large-cell; or Transformed diffuse large cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
- Patients diagnosed with diffuse large cell lymphoma at study enrollment must have a historical or contemporaneous lymph node biopsy that demonstrates a diagnosis of follicular lymphoma.
- Recurrent lymphoma after at least three qualifying therapy regimens including at least one Rituximab-containing regimen and at least one chemotherapy regimen.
- The patient must have either not responded or responded with a duration of response of less than 6 months to a Rituximab-containing regimen, Performance status of at least 70% on the Karnofsky Scale and an anticipated survival of at least three months.
Key exclusion criteria (14 listed)
- Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days prior to study enrollment.
- Hypocellular bone marrow (</=15% cellularity or marked reduction in bone marrow precursors).
- Prior myeloablative therapy.
- History of failed stem cell collection.
- Prior radiotherapy to fields encompassing more than 25% of the blood forming marrow.
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 |
|---|---|---|
| Ibritumomab Tiuxetan | Drug | – |
| Iodine I 131 Tositumomab | Drug | – |
Primary outcome
The primary endpoint is the proportion of subjects experiencing Grade 3/4 hematological toxicity within 120 days from completion of treatment regimen administration.
1 secondary outcome
The final analysis will be carried out when 130 events (progressive disease, death or subsequent therapy) have occurred in the control arm, expected approximately 18 months after last subject last visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibritumomab Tiuxetan and Iodine I 131 Tositumomab in people with Lymphoma, Small Cleaved-Cell, Follicular and Lymphoma, Large-Cell, Follicular, run by GlaxoSmithKline at 8 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 11 inclusion and 14 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: withdrawn, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint is the proportion of subjects experiencing Grade 3/4 hematological toxicity within 120 days from completion of treatment regimen administration.. 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 17 Apr 2015.