Non-Hodgkin's LymphomaPhase 3NCT00078598
A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkin's Lymphoma
A Phase 3 study testing Rituximab or Iodine I 131 Tositumomab Therapy in people with Non-Hodgkin's Lymphoma, run by Corixa Corporation at 5 sites in United States.
Trial summary
A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe. Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada - Rituxan®; EU - Mabthera®), given as an IV infusion once weekly for 4 weeks. 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?
- Rituximab or Iodine I 131 Tositumomab Therapy
- How many people
- 506 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2004to not given
- 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
- A histologically confirmed diagnosis of follicular lymphoma, Grade I, II, or III (WHO/REAL Classification) (follicular, small cleaved; follicular, mixed small-cleaved and large-cell; or follicular large-cell lymphoma in the International Working Formulation).
- Recurrent lymphoma after one or two qualifying therapy regimen(s).
- A performance status of at least 70% on the Karnofsky Scale.
- An absolute neutrophil count > 1500 cells/mm3 and a platelet count > 100,000 cells/mm3.
- Adequate renal function and adequate hepatic function.
- Bi-dimensionally measurable disease with at least one lesion measuring > or equal to 2.0 x 2.0 cm (i.e., > 4.0 cm2) by CT scan.
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- HAMA negative.
- At least 18 years of age.
- Give written informed consent by signing an IRB/ethics committee approved informed consent form prior to study entry.
Who cannot join
- Histological transformation to diffuse,large cell lymphoma
- More than 1 course of rituximab
- Disease better treated with limited field therapy
- Involvement of >25% of the intratrabecular marrow
- Active infection
- Significant cardiac disease
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- Prior ChemoRx, biological therapy, radiation Rx, or high dose systemic steroid therapy within 8 weeks
- Prior radioimmunotherapy
- History of another malignancy
- HBsAg positivity
- CNS involvement with lymphoma
- Pregnant or nursing
- Ascites by physical exam
- Previous use of non-human monoclonal antibody therapy, known hypersensitive to murine proteins
- Hydronephrosis
- Radiotherapy to >25% of the blood forming marrow
- Prior stem cell transplant
- Failed stem cell harvest
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Barry Boatman, RN, 404-303-3355, barry.boatman@northside.com
Ronald Steis, MD
- Not yet recruiting
Medical Oncology/Hematology Associates
Dayton, Ohio, 45409
Cathy Hull, RN, 937-223-2183
Basel Yanes, MD
- Not yet recruiting
West Virginia University/Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
Robin Weisenborn, MT, CCRC, 304-293-3709, WeisenbornR@rcbhsc.wvu.edu
Solveig Ericson, MD, PhD
- Not yet recruiting
Madigan Army Medical Center
Tacoma, Washington, 98431
Carol Dean, RN, 253-968-3681, carol.ford@nw.amedd.army.mil
David E McCune, MD, MPH
- Recruiting
St Mary Medical Center/Regional Cancer Center
Walla Walla, Washington, 99362
Cathy McCauley, RN, 509-522-5993, mccaca@smmc.com
Matthew Sacks, MD
About this study
Official title: A Multi-Center, Randomized, Phase III Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma
A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe.
Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada - Rituxan®; EU - Mabthera®), given as an IV infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the "dosimetric dose," patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0, Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from these three imaging timepoints, the patient's weight, and platelet count, a patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second phase, termed the "therapeutic dose," patients in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered activity of Iodine 131-conjugated Tositumomab (35 mg).
Patients on study will be followed for response and safety at Week 7, Week 13, and every 3 months for the first and second years, every 6 months for the third year, and then annually for the fourth and fifth years. Patients will be followed for safety only annually for years 6-10.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Rituximab or Iodine I 131 Tositumomab Therapy
- Keywords
- Relapsed, Follicular
- 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.
Rituximab or Iodine I 131 Tositumomab TherapyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2004 (estimated)
- Study startApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 506 participants
Sponsor and investigators
- Lead sponsor
- Corixa Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078598
- Sponsor's protocol ID
- CCBX001-049
- Status last verified
- Oct 2004
- First submitted
- 1 Mar 2004
- Last updated
- 9 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Phase III Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00078598
- Acronym / sponsor ID
- CCBX001-049
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- Relapsed, Follicular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 506 participants
- Lead sponsor
- Corixa CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- First posted
- 3 Mar 2004 (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.
A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe.
Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada - Rituxan®; EU - Mabthera®), given as an IV infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the "dosimetric dose," patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0, Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from these three imaging timepoints, the patient's weight, and platelet count, a patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second phase, termed the "therapeutic dose," patients in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered activity of Iodine 131-conjugated Tositumomab (35 mg).
Patients on study will be followed for response and safety at Week 7, Week 13, and every 3 months for the first and second years, every 6 months for the third year, and then annually for the fourth and fifth years. Patients will be followed for safety only annually for years 6-10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (9 listed)
- A histologically confirmed diagnosis of follicular lymphoma, Grade I, II, or III (WHO/REAL Classification) (follicular, small cleaved; follicular, mixed small-cleaved and large-cell; or follicular large-cell lymphoma in the International Working Formulation).
- Recurrent lymphoma after one or two qualifying therapy regimen(s).
- A performance status of at least 70% on the Karnofsky Scale.
- An absolute neutrophil count > 1500 cells/mm3 and a platelet count > 100,000 cells/mm3.
- Adequate renal function and adequate hepatic function.
Key exclusion criteria (18 listed)
- Histological transformation to diffuse,large cell lymphoma
- More than 1 course of rituximab
- Disease better treated with limited field therapy
- Involvement of >25% of the intratrabecular marrow
- Active 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 |
|---|---|---|
| Rituximab or Iodine I 131 Tositumomab Therapy | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2005.
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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.
5 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 Rituximab or Iodine I 131 Tositumomab Therapy in people with Non-Hodgkin's Lymphoma, run by Corixa Corporation at 5 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 18 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: status not confirmed, as of the sponsor's last update on 9 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 9 Nov 2005.