| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-2006-0260 | Other Identifier | UT MD Anderson Cancer Center | |
| CDR0000521620 | Registry Identifier | NCI PDQ | |
| NCI-2009-00187 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Bayer | INDUSTRY |
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RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma.
PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV on days 1, 8, 15, and 22 and sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5. Treatment with GM-CSF repeats weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection at baseline for correlative laboratory studies of Fc-gamma receptor RIIIa 158 polymorphism.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab + GM-CSF | Experimental | Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate | Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities [e.g., lactate dehydrogenase (LDH)] definitely assignable to NHL. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. | 12 weeks (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-Free Survival (PFS) | PFS is defined as the duration of time from start of treatment to time of progression; and, for PFS time calculated from chemo start date to progression date or death date, whichever happened first. Patients were censored at the last follow-up date if neither progression nor death occurred. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. The Kaplan-Meier method was used for time-to-event analysis including PFS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Fowler, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
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Recruitment period: December 2006 and May 2009. All recruitment was done in medical clinics in participating Community Clinical Oncology Program sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab + GM-CSF | Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab + GM-CSF | Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Response Rate | Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities [e.g., lactate dehydrogenase (LDH)] definitely assignable to NHL. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. | Response includes unconfirmed CRs. | Posted | Number | percentage of participants | 12 weeks (3 months) |
|
Adverse events collected through 8 week treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab + GM-CSF | Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Operations Team, Office of VP Clinical Research | UT MD Anderson Cancer Center | 713-792-7734 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C081222 | sargramostim |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Sargramostim (GM-CSF) | Biological | 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab. |
|
|
| 3 years |
| Overall Response (OR) Rate | OS defined as percentage of participants alive at a certain period following start of chemotherapy treatment. | 3 Months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Median Progression-Free Survival (PFS) | PFS is defined as the duration of time from start of treatment to time of progression; and, for PFS time calculated from chemo start date to progression date or death date, whichever happened first. Patients were censored at the last follow-up date if neither progression nor death occurred. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. The Kaplan-Meier method was used for time-to-event analysis including PFS. | Posted | Median | 95% Confidence Interval | Months | 3 years |
|
|
|
| Secondary | Overall Response (OR) Rate | OS defined as percentage of participants alive at a certain period following start of chemotherapy treatment. | Posted | Number | percentage of participants | 3 Months |
|
|
|
| 10 |
| 52 |
| 52 |
| 52 |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue/weakness | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infusion reaction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Central Nervous System (CNS) ischemia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergy/Immunology, Other: Mild allergy symptoms | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred Vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac General | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Chest Tightness | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constitutional Symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dermatology/Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema, Facial | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema: Head And Neck | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema: Limb | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever Without Neutropenia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal, Other: Gastritis or related symptoms | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemoglobin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypotension | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection (Other) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Injection Site Reaction | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Leukocytes Change/Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Memory Impairment | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Mental Status | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Metabolic/Laboratory, Other: change in blood levels | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mood Alteration, not interfering with function | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mood Alteration | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal, Other: pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neurology (Other) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy: Motor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy: Sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ocular Surface Discomfort | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Ocular/Visual | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Abdomen Nos) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Back) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Bone) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Chest Wall) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Chest/Thorax) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Extremity-Limb) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Head/Headache) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Muscle) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Neck) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Nos) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Other) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Scrotum) | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain (Throat/Pharynx) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary (Other) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash/Desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Redness Of Eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rigors/Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin Lesion | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Voice Changes | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Watery Eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |