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Phase III, Randomized, Double Blind, Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular B-Cell Non-Hodgkin's Lymphoma

Phase 3
18 Years
Not Enrolling

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Trial Information

Phase III, Randomized, Double Blind, Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular B-Cell Non-Hodgkin's Lymphoma



- Compare time to disease progression in patients with grade 1, 2, or 3 follicular B-cell
non-Hodgkin's lymphoma who respond (i.e., complete or partial response, or stable
disease) to treatment with rituximab and are then treated with sargramostim (GM-CSF)
with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine.


- Compare response rate improvement in patients treated with these regimens.

- Compare overall complete response rate in patients treated with these regimens.

- Compare duration of response in patients treated with these regimens.

- Determine the safety of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior treatment (yes vs no) and response to rituximab during
study (complete response [CR] or partial response [PR] vs stable disease [SD]).

All patients receive rituximab IV once weekly for 4 weeks. Five weeks after the last dose of
rituximab, patients are assessed for response. Patients with progressive disease are removed
from the study and do not undergo randomization. Patients with a CR, PR, or SD are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine
subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days

- Arm II: Patients receive placebo SC on day 1. Patients also receive GM-CSF SC on days

In both arms, treatment repeats monthly for 6 months in the absence of unacceptable toxicity
or clinically significant progressive disease. After the first 6 months, patients with a CR,
PR, or SD may continue to receive treatment (per treatment arm as above) every 2 months for
1 year (total of 6 doses) and then every 3 months thereafter in the absence of disease

Patients are followed every 3 months for 2 years and then every 6 months until disease

PROJECTED ACCRUAL: A total of 342 evaluable patients (171 per treatment arm) will be accrued
for this study within 18 months.

Inclusion Criteria


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

- Grade 1, 2, or 3

- Meets 1 of the following criteria for treatment with rituximab:

- Treatment naïve

- Relapsed or refractory disease after prior chemotherapy

- Relapsed after a prior documented response (i.e., complete or partial response)
to rituximab of at least 6 months duration

- Tumor accessible for biopsy OR existing biopsy material (taken within the past 6
months) suitable for vaccine preparation

- Measurable or evaluable disease after tumor tissue procurement for vaccine production

- No more than 2 prior treatment regimens for NHL

- Single regimens include any of the following:

- Maintenance rituximab

- Rituximab administered once weekly for 8 courses

- Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus
rituximab* NOTE: *CHOP followed by rituximab at time of relapse is
considered 2 treatment regimens

- No history of CNS lymphoma or meningeal lymphomatosis



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 75,000/mm^3 (unless related to bone marrow involvement by lymphoma)

- Hemoglobin ≥ 10g/dL


- Not specified


- Not specified


- No congestive heart failure


- No compromised pulmonary function


- HIV negative

- No prior allergic response to GM-CSF

- No active bacterial, viral, or fungal infection


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No psychiatric disorder that would preclude study participation

- No other malignancy within the past 2 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No other serious nonmalignant disease that would preclude study participation


Biologic therapy

- See Disease Characteristics

- See Chemotherapy

- At least 4 weeks since prior immunotherapy

- No prior radiolabeled anti-lymphoma antibody (e.g., iodine I 131 tositumomab or
ibritumomab tiuxetan)

- No prior autologous or allogeneic stem cell transplantation

- No prior lymphoma-specific idiotype immunotherapy (e.g., Id vaccine)

- No prior investigational vaccine or immunotherapeutic containing keyhole limpet
hemocyanin (KLH)


- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- More than 9 months since prior fludarabine

- More than 2 years since prior chemotherapy/rituximab combination therapy (e.g.,
CHOP/rituximab or cyclophosphamide, vincristine, and prednisone [CVP]/rituximab)

- No more than 6 total prior treatment courses with fludarabine

Endocrine therapy

- No concurrent steroids for allergic reaction to sargramostim (GM-CSF)


- See Biologic therapy

- At least 4 weeks since prior radiotherapy


- Not specified


- At least 4 weeks since prior experimental therapy

- No concurrent systemic immunosuppressive therapy

- No other concurrent anti-lymphoma therapy

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Time to progression after 248 patients have progressed

Safety Issue:


Principal Investigator

John F. Bender, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



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