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Rituxan

Phase 2

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Dynavax Technologies Corporation|Last Updated: Jan 29, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Rituxan · 1 trial · 1 indication

Phase 2 1
NCT00251394Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular LymphomaNon-Hodgkin's Lymphoma
COMPLETED30 Analytics
PHASE2COMPLETED
Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma
Non-Hodgkin's LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy.
2 years

Secondary Endpoints

To assess the overall response rate following treatment
2 years
to determine duration of response and time to progression
to further define the safety profile of 1018 ISS
2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
RituxanDRUGGiven intravenously once weekly for four weeks.
1018 ISSDRUGGiven as an injection under the skin after the 2nd, 3rd and 4th rituxan infusion. One week after the last rituxan infusion is given, a fourth and final 1018ISS injection will be given.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 18 years of age or older * Pathological evidence of CD20+, B-cell follicular non-Hodgkin's lymphoma * Received at least one previous chemotherapy regimen for lymphoma * Hemoglobin \> 8.5 g/dl * WBC \> 2,000/mm3 * ANC \> 1,000/mm3 * Platelet count \> 75,000/mm3 * ECOG performan...

Countries:United States
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Frequently asked questions about Rituxan

What is Rituxan used for in Non-Hodgkin's Lymphoma?

Rituxan is used for the treatment of Non-Hodgkin's Lymphoma, specifically B-cell follicular lymphoma. It is being studied in combination with an investigational immunostimulatory sequence (ISS) in a Phase 2 clinical trial. The drug is developed by Dynavax Technologies Corporation.

Who makes Rituxan?

Rituxan is developed by Dynavax Technologies Corporation, a biopharmaceutical company traded under the ticker DVAX. The company is conducting clinical research on Rituxan for Non-Hodgkin's Lymphoma, with a completed Phase 2 trial evaluating its use in patients with B-cell follicular lymphoma.

What phase is Rituxan in?

Rituxan is in Phase 2 clinical development for Non-Hodgkin's Lymphoma. A Phase 2 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities, and its safety and efficacy are still being evaluated in clinical studies.

What clinical trials is Rituxan in?

Rituxan has been studied in a Phase 2 clinical trial with the identifier NCT00251394. The trial, titled 'Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma,' enrolled 30 participants in the United States. The study is completed and was not randomized or blinded.

Is Rituxan the same as 1018 ISS?

No, Rituxan is not the same as 1018 ISS. Rituxan is the drug being studied, while 1018 ISS is an investigational immunostimulatory sequence used in combination with Rituxan in the clinical trial. The trial evaluated the effects of 1018 ISS following Rituxan treatment in patients with B-cell follicular lymphoma.