search
Back to results

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

Primary Purpose

Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Id-KLH
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Unversity of Nebraska Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1 High dose BEAM chemotherapy, transplant & idiotype vaccine therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2007
Last Updated
September 12, 2023
Sponsor
University of Nebraska
Collaborators
Genitope Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00574886
Brief Title
Idiotype Vaccine After Chemotherapy & Stem Cell Transplantation in Lymphoma With Failed Induction Chemotherapy
Official Title
Pilot Trial for Idiotype Vaccine Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Patients With Lymphoma Who Had Failed Induction Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2000 (Actual)
Primary Completion Date
March 1, 2002 (Actual)
Study Completion Date
April 15, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Genitope Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 High dose BEAM chemotherapy, transplant & idiotype vaccine therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Id-KLH
Other Intervention Name(s)
Vacmun KLH
Intervention Description
Idiotype vaccine - .5mg recombinant idiotype immunoglobulin protein given subcutaneously for a total of five administrations over 6 months.
Primary Outcome Measure Information:
Title
Humoral and cellular responses to idiotype vaccine following high-dose chemotherapy and hematopoietic stem cell transplant
Description
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
Secondary Outcome Measure Information:
Title
Safety and toxicity of idiotype vaccine post-transplant setting
Description
Safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Time Frame
Post-transplant vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Vose, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs