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1018 ISS

Phase 2

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

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Nov 2001

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

1018 ISS · 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 1018 ISS

What is 1018 ISS used for?

1018 ISS is an investigational therapy being studied in Non-Hodgkin's Lymphoma, specifically B-cell follicular lymphoma. It was evaluated in a Phase 2 study following treatment with Rituxan in patients with this condition. It is not an approved treatment and remains in clinical development.

Who is developing 1018 ISS?

1018 ISS is being developed by Dynavax Technologies Corporation, which trades under the ticker DVAX. The company sponsored the clinical research evaluating this agent in B-cell follicular lymphoma. Dynavax is the developer associated with this asset.

What phase is 1018 ISS in?

1018 ISS is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program enrolled 30 patients in total. As an investigational agent, it has not been approved for any indication.

What clinical trials is 1018 ISS in?

1018 ISS has been studied in one clinical trial, NCT00251394, titled Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma. This Phase 2 trial was completed, enrolled 30 patients, and was conducted in the United States.

What is 1018 ISS used for in Non-Hodgkin's Lymphoma?

1018 ISS was studied in Non-Hodgkin's Lymphoma, specifically B-cell follicular lymphoma, following Rituxan treatment. The Phase 2 trial NCT00251394 evaluated it in this patient population. It is an investigational agent and is not approved for treating Non-Hodgkin's Lymphoma.