An interventional study of Id-KLH in Lymphoma, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 2 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
Biological: Id-KLH
Idiotype vaccine - .5mg recombinant idiotype immunoglobulin protein given subcutaneously for a total of five administrations over 6 months.
Also known as: Vacmun KLH
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
Time frame: After vaccination
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
Time frame: Post-transplant vaccination
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Nebraska