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1018 ISS

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

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 Lymphoma
NCT0025139430
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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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