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

University of Nebraska

Status: Completed

Conditions: Lymphoma

Treatments: Biological: Id-KLH

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00574886

0267-00-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

1 High dose BEAM chemotherapy, transplant & idiotype vaccine therapy

Experimental group

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.

Treatment:

Biological: Id-KLH