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A Comparison Of Rituximab vs. Iodine I 131 Tositumomab Therapeutic Regimen (i.e., BEXXAR®) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
This study has been terminated.
First Received: December 21, 2005   Last Updated: May 15, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00268983
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Iodine I 131 Tositumomab Therapeutic Regimen
Drug: Rituximab
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Measures:
  • Confirmed response rates, response duration, time to next treatment, progression-free & overall survival. Safety of rituximab and Iodine I 131 Tositumomab.

Estimated Enrollment: 506
Study Start Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268983

Locations
United States, Washington
GSK Investigational Site
Walla Walla, Washington, United States, 99362
United Kingdom, Lancashire
GSK Investigational Site
Manchester, Lancashire, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 393229/028, CCBX001-049
Study First Received: December 21, 2005
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00268983     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
non-Hodgkins lymphoma
NHL
rituximab

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Rituximab
Growth Substances
Physiological Effects of Drugs
Lymphoma, Follicular
Iodine-131 anti-B1 antibody
Trace Elements
Pharmacologic Actions
Antibodies, Monoclonal
Anti-Infective Agents, Local
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Iodine
Micronutrients
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 05, 2009