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| Name | Class |
|---|---|
| Genitope Corporation | INDUSTRY |
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This is a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on previous trials. These participants then went on to high dose BEAM chemotherapy and transplant, then received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants were then followed annually until progression or death with standard staging.
This trial was made available as a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on trials 0197-99-FB and 0196-99-FB. These follicular NHL participants then went on to high dose BEAM chemotherapy and transplant. Patients received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants are then followed annually until progression or death with standard staging. Immune response testing continues annually on participants who continue to have a response post transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 High dose BEAM chemotherapy, transplant & idiotype vaccine therapy | Experimental | This is a compassionate use protocol for participants who failed induction chemotherapy + Vaccine on previous trials. These participants then went on to high dose BEAM chemotherapy and transplant, then received idiotype vaccine therapy at 3 months post transplant. Vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. Participants were then followed annually until progression or death with standard staging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Id-KLH | Biological | Idiotype vaccine - .5mg recombinant idiotype immunoglobulin protein given subcutaneously for a total of five administrations over 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Humoral and cellular responses to idiotype vaccine following high-dose chemotherapy and hematopoietic stem cell transplant | Humoral and cellular responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with lymphoma following high-dose chemotherapy and | After vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toxicity of idiotype vaccine post-transplant setting | Safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting | Post-transplant vaccination |
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Inclusion Criteria:
histologically confirmed aggressive or indolent, B-cell non-hodgkins lymphoma
original enrollment in vaccine protocol for newly diagnosed lymphoma and had successful production of idiotype vaccine
failed to achieve PR or CR with initial induction chemotherapy, received salvage chemotherapy and then stem cell transplant and achieved a CR or good PR following transplantation
->/= 19 years
signed informed consent
non-pregnant, non-lactating
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Vose, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |