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Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06



- Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine
(FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3
follicular B-cell non-Hodgkin's lymphoma who did not receive FavId™ while enrolled on
protocol FAV-ID-06.


- Determine the response rate and duration of response in patients treated with this

- Determine the response rate and response rate improvement after best response to prior
salvage therapy in patients treated with this regimen.

- Determine the time to progression in patients treated with this regimen.

- Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to
timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression
after prior rituximab AND never randomized vs disease progression after randomization to
placebo arm).

Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day
1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for
6 months in the absence of disease progression or unacceptable toxicity. Patients with
stable or responding disease may receive additional treatment as above every 2 months for 1
year (6 treatments) and every 3 months until disease progression.

After completion of study treatment, patients are followed for 30 days or until the start of
subsequent treatment.

PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be
accrued for this study.

Inclusion Criteria


- Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

- Grade 1, 2, or 3

- Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH
conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06

- Meets 1 of the following criteria:

- Received salvage therapy after completion of protocol FAV-ID-06

- At least 4 weeks, but no more than 4 months, since prior salvage therapy

- Did not receive salvage therapy after completion of protocol FAV-ID-06

- At least 4 weeks, but no more than 4 months, since completion of prior
treatment on protocol FAV-ID-06

- No history of CNS lymphoma OR meningeal lymphomatosis



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- No history of congestive heart failure


- No history of compromised pulmonary function


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No active bacterial, viral, or fungal infection

- No psychiatric disorder

- No other serious nonmalignant disease that would preclude study participation


Biologic therapy

- See Disease Characteristics

- No prior allogeneic transplantation*

- No prior rituximab regimen* other than that administered on protocol FAV-ID-06
(rituximab 375 mg/m^2 IV weekly for 4 weeks)


- No prior purine analogues* (e.g., fludarabine or cladribine)

Endocrine therapy

- No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement)


- Not specified


- Not specified


- Recovered from prior salvage therapy

- No prior or concurrent immunosuppressive therapy

- No prior investigational agents*

- No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered
between completion of protocol FAV-ID-06 and enrollment onto this study

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06

Safety Issue:


Principal Investigator

John F. Bender, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:




Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

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



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