Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab (BEXXAR® Therapeutic Regimen) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00268983
• Date of registration: 21/12/2005
• Primary sponsor: GlaxoSmithKline
• Public title: Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab (BEXXAR® Therapeutic Regimen) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma
• Scientific 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
• Date of first enrolment: October 2004
• Target sample size: 14
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00268983
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Denmark, France, Germany, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials, MD
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma, Non-Hodgkin

Non-Hodgkin's Lymphoma

Intervention(s)

Biological: Rituximab

Biological: Tositumomab and Iodine I 131 Tositumomab

Primary Outcome(s)

Progression-free Survival [Time Frame: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and Bexxar groups was 38.9 and 42.2 months, respectively)]

Secondary Outcome(s)

Duration of Response [Time Frame: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually]

Number of Participants Achieving Response [Time Frame: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually]

Number of Participants Who Had Died by the Month Indicated [Time Frame: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and Bexxar groups was 38.9 and 42.2 months, respectively)]

Number of Participants With the Indicated Duration of Response [Time Frame: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually]

Time to Death [Time Frame: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and Bexxar groups was 38.9 and 42.2 months, respectively)]

Secondary ID(s)

393229/028

CCBX001-049

Source(s) of Monetary Support

Please refer to primary and secondary sponsors