Skip to main content
OpenTrials
Completed

NCT Number: NCT00574886

Idiotype Vaccine After Chemotherapy & Stem Cell Transplantation in Lymphoma With 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Id-KLH

Biological

Idiotype vaccine - .5mg recombinant idiotype immunoglobulin protein given subcutaneously for a total of five administrations over 6 months.

Other names: Vacmun KLH

Primary outcomes

  1. Humoral and cellular responses to idiotype vaccine following high-dose chemotherapy and hematopoietic stem cell transplant

    Time frame: 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 outcomes

  1. Safety and toxicity of idiotype vaccine post-transplant setting

    Time frame: Post-transplant vaccination

    Safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Genitope Corporation

Registry information

Official study title

Pilot Trial for Idiotype Vaccine Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Patients With Lymphoma Who Had Failed Induction Chemotherapy

Important dates

Study start
2000
Primary completion
2002
Study completion
2008
First posted
Dec 17, 2007
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.