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Iodine I 131 Tositumomab

Phase 3

Non-Hodgkin's Lymphoma | Monoclonal antibody | Oncology |GSK plc|Trials Updated: Sep 17, 2007

Iodine I 131 Tositumomab development status

Highest phase Phase 3 (NCT00319332)
Phase scored for GSKPhase 1
Registered trials 2 across 1 sponsor since Jun 2003

Iodine I 131 Tositumomab target and mechanism

ModalityMonoclonal antibody

Also known as Bexxar Therapeutic Regimen, anti-B1 Antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Iodine I 131 Tositumomab clinical trials

Iodine I 131 Tositumomab · 1 trial · 1 indication

Phase 1 1
NCT00062894Study of Untreated or Transformed Follicular Non-Hodgkin's Lymphoma With Fission-Derived Iodine I 131 TositumomabNon-Hodgkin's Lymphoma
COMPLETED12 Analytics
PHASE1COMPLETED
Study of Untreated or Transformed Follicular Non-Hodgkin's Lymphoma With Fission-Derived Iodine I 131 Tositumomab
Non-Hodgkin's LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma

Secondary Endpoints

12 patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma will receive a dosimetric dose of fission-derived Iodine I 131 Tositumomab
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Iodine I 131 TositumomabDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * At least 18 years of age * Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma (WHO/REAL classification). Follicular, small cleaved; Follicular, mixed small cleaved and large cell; Follicular large cell lymphoma Transfor...

Countries:United States
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Frequently asked questions about Iodine I 131 Tositumomab

What is Iodine I 131 Tositumomab?

Iodine I 131 Tositumomab is an investigational monoclonal antibody-based oncology therapy being developed by GSK plc for Non-Hodgkin's Lymphoma. It combines a monoclonal antibody with the radioisotope iodine I 131. It is in Phase 1 clinical development and is not approved for commercial use.

What is Iodine I 131 Tositumomab used for in Non-Hodgkin's Lymphoma?

Iodine I 131 Tositumomab is being studied for the treatment of Non-Hodgkin's Lymphoma, specifically in patients with untreated or transformed follicular Non-Hodgkin's Lymphoma. The only recorded clinical trial enrolled adults 18 years and older in the United States. It remains an investigational agent in Phase 1 development.

Who makes Iodine I 131 Tositumomab?

GSK plc, which trades under the ticker GSK, is the developer of Iodine I 131 Tositumomab. The company is responsible for the clinical program evaluating the agent in Non-Hodgkin's Lymphoma. No other developer or partnership is associated with this asset in the available program information.

What phase is Iodine I 131 Tositumomab in?

Iodine I 131 Tositumomab is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The program has one completed Phase 1 trial and no active trials, with a total reported enrollment of 12 patients.

What clinical trials is Iodine I 131 Tositumomab in?

Iodine I 131 Tositumomab has been evaluated in one clinical trial, NCT00062894, titled Study of Untreated or Transformed Follicular Non-Hodgkin's Lymphoma With Fission-Derived Iodine I 131 Tositumomab. That Phase 1 trial is completed, enrolled 12 patients in the United States, was uncontrolled, and was not randomized or double blinded.