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Iodine I 131 Tositumomab

Phase 1

Non-Hodgkin's Lymphoma | Small molecule | Oncology |GSK plc|Last Updated: Sep 17, 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Iodine I 131 Tositumomab is used for Non-Hodgkin's Lymphoma, specifically studied in untreated or transformed follicular Non-Hodgkin's Lymphoma. It is an investigational small molecule in Phase 1 clinical development, and it is not approved by the FDA.

Who makes Iodine I 131 Tositumomab?

Iodine I 131 Tositumomab is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this investigational drug for Non-Hodgkin's Lymphoma.

What phase is Iodine I 131 Tositumomab in?

Iodine I 131 Tositumomab is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied for safety and efficacy in patients with Non-Hodgkin's Lymphoma.

What clinical trials is Iodine I 131 Tositumomab in?

Iodine I 131 Tositumomab has one completed clinical trial, NCT00062894, which studied untreated or transformed follicular Non-Hodgkin's Lymphoma. The trial enrolled 12 participants in the United States and was not randomized or double-blinded.

Is Iodine I 131 Tositumomab FDA approved?

Iodine I 131 Tositumomab is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Non-Hodgkin's Lymphoma, and its safety and effectiveness have not been established.