Idiotype Vaccine After Chemotherapy & Stem Cell Transplantation in Lymphoma With Failed Induction Chemotherapy

Not Applicable

Completed

• Conditions: Lymphoma
• Interventions: Biological: Id-KLH

• Registration Number: NCT00574886
• Lead Sponsor: University of Nebraska

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-08-03
• Primary Completion: 2002-03-01
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Study Completion: 2008-04-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

• serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 High dose BEAM chemotherapy, transplant & idiotype vaccine therapy	Id-KLH	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.

Primary Outcome Measures

Name	Time	Method
Humoral and cellular responses to idiotype vaccine following high-dose chemotherapy and hematopoietic stem cell transplant	After vaccination	Humoral and cellular responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with lymphoma following high-dose chemotherapy and

Secondary Outcome Measures

Name	Time	Method
Safety and toxicity of idiotype vaccine post-transplant setting	Post-transplant vaccination	Safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States