Suspended

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

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What is being tested

Data Collection

Who is being recruted

Immune System Diseases
+5

+ Immunoproliferative Disorders
+ Lymphatic Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorFavrille
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * 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. Secondary * 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 1-4. * Arm II: Patients receive placebo SC on day 1. Patients also receive GM-CSF SC on days 1-4. 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 progression. Patients are followed every 3 months for 2 years and then every 6 months until disease progression. PROJECTED ACCRUAL: A total of 342 evaluable patients (171 per treatment arm) will be accrued for this study within 18 months.

Official TitlePhase 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 
NCT00089115
Principal SponsorFavrille
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Criteria

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 (unless related to bone marrow involvement by lymphoma) * Hemoglobin ≥ 10g/dL Hepatic * Not specified Renal * Not specified Cardiovascular * No congestive heart failure Pulmonary * No compromised pulmonary function Immunologic * HIV negative * No prior allergic response to GM-CSF * No active bacterial, viral, or fungal infection Other * 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 PRIOR CONCURRENT THERAPY: 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) Chemotherapy * 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) Radiotherapy * See Biologic therapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * At least 4 weeks since prior experimental therapy * No concurrent systemic immunosuppressive therapy * No other concurrent anti-lymphoma therapy


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 60 locations
Suspended
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, United StatesSee the location
Suspended
Mayo Clinic ScottsdaleScottsdale, United States
Suspended
Tower Cancer Research FoundationBeverly Hills, United States
Suspended
Rebecca and John Moores UCSD Cancer CenterLa Jolla, United States

Suspended60 Study Centers
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