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Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
autologous immunoglobulin idiotype-KLH conjugate vaccine
rituximab
sargramostim
Sponsored by
Favrille
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • Mayo Clinic Scottsdale
  • Tower Cancer Research Foundation
  • Rebecca and John Moores UCSD Cancer Center
  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
  • Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
  • Sharp Memorial Hospital Cancer Center
  • UCSF Comprehensive Cancer Center
  • Stanford Cancer Center at Stanford University Medical Center
  • Kaiser Permanente Medical Center - Vallejo
  • Rocky Mountain Cancer Centers - Denver Midtown
  • Medical Oncology Hematology Consultants, P.A. at Helen F. Graham Cancer Center
  • Lombardi Cancer Center at Georgetown University Medical Center
  • Center for Hematology-Oncology - Boca Raton
  • University of Florida Health Science Center - Jacksonville
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • North Idaho Cancer Center
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Rush University Medical Center
  • Indiana University Cancer Center
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Ochsner Cancer Institute at Ochsner Clinic Foundation
  • Greater Baltimore Medical Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Barbara Ann Karmanos Cancer Institute
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Mayo Clinic Cancer Center
  • Siteman Cancer Center at Barnes-Jewish Hospital
  • Montana Cancer Specialists at Montana Cancer Center
  • New Mexico Cancer Center
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • North Shore University Hospital
  • Beth Israel Medical Center - Philipps Ambulatory Care Center
  • Memorial Sloan-Kettering Cancer Center
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Comprehensive Cancer Center at Wake Forest University
  • Mid Dakota Clinic, P. C.
  • Roger Maris Cancer Center at MeritCare Hospital
  • Charles M. Barrett Cancer Center at University Hospital
  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • Providence Cancer Center at Providence Portland Medical Center
  • Kaiser Permanente Medical Office - Interstate Medical Office Central
  • Cancer Institute at Oregon Health and Science University
  • Geisinger Medical Center
  • Fox Chase-Temple Cancer Center
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  • Sarah Cannon Cancer Center at Centennial Medical Center
  • Baylor University Medical Center - Dallas
  • M.D. Anderson Cancer Center at University of Texas
  • Cancer Care Network of South Texas
  • University of Virginia Cancer Center
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  • University of Wisconsin Comprehensive Cancer Center
  • Marshfield Clinic - Marshfield Center

Outcomes

Primary Outcome Measures

Time to progression after 248 patients have progressed

Secondary Outcome Measures

Response rate improvement after 248 patients have progressed
Overall complete response rate by modified Cheson Criteria after 248 patients have progressed
Duration of response by modified Cheson Criteria after 248 patients have progressed
Safety by Common Toxicity Criteria (CTC) after 248 patients have progressed

Full Information

First Posted
August 4, 2004
Last Updated
August 1, 2013
Sponsor
Favrille
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1. Study Identification

Unique Protocol Identification Number
NCT00089115
Brief Title
Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn as company has shut down and filed for bankruptcy
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Favrille

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with vaccine therapy may cause a stronger immune response and kill more cancer cells. PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
autologous immunoglobulin idiotype-KLH conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Biological
Intervention Name(s)
sargramostim
Primary Outcome Measure Information:
Title
Time to progression after 248 patients have progressed
Secondary Outcome Measure Information:
Title
Response rate improvement after 248 patients have progressed
Title
Overall complete response rate by modified Cheson Criteria after 248 patients have progressed
Title
Duration of response by modified Cheson Criteria after 248 patients have progressed
Title
Safety by Common Toxicity Criteria (CTC) after 248 patients have progressed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F. Bender, PharmD
Organizational Affiliation
Favrille
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Tower Cancer Research Foundation
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sharp Memorial Hospital Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0324
Country
United States
Facility Name
Stanford Cancer Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Kaiser Permanente Medical Center - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Denver Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Medical Oncology Hematology Consultants, P.A. at Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713-2055
Country
United States
Facility Name
Lombardi Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Center for Hematology-Oncology - Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Florida Health Science Center - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
North Idaho Cancer Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Ochsner Cancer Institute at Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204-6881
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466-2604
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Beth Israel Medical Center - Philipps Ambulatory Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Mid Dakota Clinic, P. C.
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58502-5538
Country
United States
Facility Name
Roger Maris Cancer Center at MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5047
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Permanente Medical Office - Interstate Medical Office Central
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Fox Chase-Temple Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Sarah Cannon Cancer Center at Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor University Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Cancer Care Network of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19414675
Citation
Freedman A, Neelapu SS, Nichols C, Robertson MJ, Djulbegovic B, Winter JN, Bender JF, Gold DP, Ghalie RG, Stewart ME, Esquibel V, Hamlin P. Placebo-controlled phase III trial of patient-specific immunotherapy with mitumprotimut-T and granulocyte-macrophage colony-stimulating factor after rituximab in patients with follicular lymphoma. J Clin Oncol. 2009 Jun 20;27(18):3036-43. doi: 10.1200/JCO.2008.19.8903. Epub 2009 May 4.
Results Reference
result

Learn more about this trial

Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

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