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Clinical Trials/NCT00510471
NCT00510471
Terminated
Phase 2

A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo)

Genitope Corporation9 sites in 1 countryMay 2007
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ConditionsNon-Hodgkin's Lymphoma
Drugsautologous immunoglobulin idiotype-KLH conjugate vaccine

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Non-Hodgkin's Lymphoma
Sponsor
Genitope Corporation
Locations
9
Status
Terminated
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together with the personalized active immunotherapy because it may increase the immune system's response and, therefore, aid in the effect of the personalized active immunotherapy.

This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile have been seen to date in these studies.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
TBD
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Genitope Corporation

Eligibility Criteria

Inclusion Criteria

  • •Written informed consent
  • •Previously untreated follicular NHL
  • •Stage III or IV disease requiring treatment
  • •Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin)
  • •Able to provide tumor sample adequate for Id-KLH manufacture
  • •≥ 18 years of age
  • •At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (9)

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