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Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma

Phase 2
19 Years
Not Enrolling

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Trial Information

Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma


- Determine the humoral and cellular immune responses in patients with follicular
non-Hodgkin's lymphoma treated with autologous lymphoma-derived idiotype vaccine with
keyhole limpet hemocyanin plus sargramostim (GM-CSF).

- Determine the safety and toxicity of this regimen in these patients in the
post-transplant setting.

- Determine the changes in quantitative bcl-2 in the blood and bone marrow of these
patients before and at various times after the series of idiotype vaccines.

OUTLINE: Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell
transplantation. Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole
limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on
days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth
and final dose.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


- Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that
failed induction therapy

- Previously received no more than 2 high-dose chemotherapies before hematopoietic stem
cell transplantation

- Minimal disease state at day 100 to 6 months post-transplantation

- Lymph nodes smaller than 2 centimeters (cm)

- Less than 20% bone marrow involvement with lymphoma

- Uncertain complete remission, defined by greater than 75% reduction in the size
of the pre-transplantation mass not representing active disease

- Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy

- Must have adequate circulating lymphoma cells



- Over 19

Performance status:

- Karnofsky greater than 70%

Life expectancy:

- Not specified


- See Disease Characteristics

- Absolute neutrophil count greater than 1,000/mm^3*

- CD4+ count greater than 200/microliter* NOTE: *No restrictions if study vaccine
administered at 6 months after transplantation


- Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement)

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic
transaminase (SGPT) less than 2 times normal (unless due to lymphomatous involvement)


- Creatinine no greater than 2.0 mg/dL


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study


Biologic therapy:

- See Disease Characteristics


- See Disease Characteristics

Endocrine therapy:

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Humoral and Cellular Immune Response

Outcome Description:

evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation

Outcome Time Frame:

immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression

Safety Issue:


Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska


United States: Food and Drug Administration

Study ID:




Start Date:

September 2000

Completion Date:

April 2008

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680