A Comparison Of Rituximab vs. Iodine I 131 Tositumomab Therapeutic Regimen (i.e., BEXXAR) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Hodgkins Lymphoma
Intervention: Iodine I 131 Tositumomab Therapeutic Regimen (Drug); Rituximab (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
Comparison of rituximab versus Iodine I 131 Tositumomab therapeutic regimen in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2 (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm B, subjects will undergo a two-phase treatment. In the first phase, termed the 'dosimetric dose', subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of 5 millicuries (mCi) (0. 18 gigabecquerel [GBq]) of Iodine 131 Tositumomab (35 mg). 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. The information derived from the scans will enable a patient specific dose to be calculated to deliver the desired total body dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the 'therapeutic dose', subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric dose and continued for 14 days following the therapeutic dose. Subjects on study will be followed for response and safety at Week 7, Week 13, and every three months for the first and second year, every six months for the third year, and then annually for the forth and fifth years; and then for vital status, additional therapy, and long term safety events through year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia (AML), HAMA or hypothyroidism, unexpected safety issues, and death.
Clinical Details
Official title:
A Multi-Center, Randomized, Phase 3 Study of Rituximab Versus Iodine I 131 Tositumomab Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Event-free survival of patients treated with rituximab to that of patients treated with the Iodine I 131 Tositumomab therapeutic regimen in patients who have had at least one, but no more than two, prior therapies for follicular non-Hodgkins lymphoma.
Secondary outcome: Confirmed response rates, response duration, time to next treatment, progression-free & overall survival. Safety of rituximab and Iodine I 131 Tositumomab.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Histologically confirmed diagnosis of follicular lymphoma
- Recurrent lymphoma after one or two qualifying therapy regimen(s)
- Patients must not have progressed within 4 weeks of their last chemotherapy dose
- Rituximab may have been used once as a single agent, in one continuous course of 4-8 weekly infusions (10-week period), or in combination with chemotherapy in a single prior treatment
- Patients whose prior therapy includes rituximab must have had a 6 month or greater response duration following the rituximab-containing regimen.
- Performance status of at least 70% on the Karnofsky Scale and an anticipated survival of at least three months
- Adequate absolute neutrophil count and platelet count within 21 days of study entry without support of blood products/growth factors
- Adequate renal function and adequate hepatic within 21 days of study entry
- Measurable disease, with at least one lesion measuring >/=2. 0 cm x 2. 0 cm by CT scan
- Human Anti Mouse Antigen negative
- Written informed consent prior to study entry
Exclusion criteria:
- Histologic transformation to diffuse, large cell lymphoma.
- History of more than one course of Rituximab
- Disease limited to single lymph node or single group of nodes
- Involvement of 25% of the intratrabecular marrow by bone marrow biopsy specimen.
- Active infection requiring IV antibiotics at the time of study entry
- New York Heart Association Class III/IV heart disease
- Prior chemotherapy, biologic, radiation or steroid therapy for NHL within 8 weeks
- Any prior radioimmunotherapy
- Prior history of malignancy other than lymphoma (except for treated basal cell, squamous cell skin cancer, in situ cervical cancer, or other cancer that is disease-free for 5 years)
- Known HIV infection
- Hepatitis B positive
- Known central nervous system involvement
Locations and Contacts
GSK Clinical Trials Call Center, Hartford, Connecticut 06102, United States
GSK Clinical Trials Call Center, Bay Pines, Florida 33744, United States
GSK Clinical Trials Call Center, Roswell, Georgia 30076, United States
GSK Clinical Trials Call Center, Copenhagen DK-2100, Denmark
GSK Clinical Trials Call Center, Muenchen D-813777, Germany
GSK Clinical Trials Call Center, Southampton S016 6YD, United Kingdom
GSK Clinical Trials Call Center, Manchester M204BX, United Kingdom
GSK Clinical Trials Call Center, Cedex 69495, France
GSK Clinical Trials Call Center, Bethesda, Maryland 20889, United States
GSK Clinical Trials Call Center, Ann Arbor, Michigan 48109, United States
GSK Clinical Trials Call Center, Winston-Salem, North Carolina 27157, United States
GSK Clinical Trials Call Center, Sylvania, Ohio 43560, United States
GSK Clinical Trials Call Center, Dayton, Ohio 45409, United States
GSK Clinical Trials Call Center, Knoxville, Tennessee 37920, United States
GSK Clinical Trials Call Center, Tacoma, Washington 98431, United States
GSK Clinical Trials Call Center, Walla Walla, Washington 99362, United States
GSK Clinical Trials Call Center, Morgantown, West Virginia 26506, United States
Additional Information
Starting date:
March 2003
Last updated: January 11, 2007
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