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Pilot Trial for Idiotype Vaccine Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Patients With Lymphoma Who Had Failed Induction Chemotherapy
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.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
Unversity of Nebraska Medical Center
Omaha, Nebraska, United States
Start Date
August 3, 2000
Primary Completion Date
March 1, 2002
Completion Date
April 15, 2008
Last Updated
December 8, 2023
2
ACTUAL participants
Id-KLH
BIOLOGICAL
Lead Sponsor
University of Nebraska
Collaborators
NCT07388563
NCT05529069
Data Source & Attribution
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