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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01670 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The goal of this clinical research study is to learn if giving granulocyte-macrophage colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of this combination treatment will also be studied.
GM-CSF is a drug designed to stimulate the immune system. It will increase the number of a certain type of blood cell called neutrophils and macrophages.
Rituximab is a drug designed to bind to a protein, called cluster of differentiation antigen 20 (CD20), that is on the surface of the leukemia cells, allowing the leukemia cells to be destroyed by the immune system.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including routine blood tests (about 2 tablespoons). A bone marrow aspirate will be collected. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Imaging studies (such as a chest x-ray or CT scans) may be performed. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will receive GM-CSF as an injection under the skin, three times a week for eight weeks. You will receive rituximab by vein, once a week for four weeks. Usually, the first dose of rituximab requires several hours to complete. Later doses should usually be shorter, but may vary according to individual tolerance. Acetaminophen (Tylenol), diphenhydramine hydrochloride (Benadryl), and steroids (hydrocortisone or similar) will be given before rituximab to decrease the risk of side effects. If side effects do occur during the infusion, you will need to stay at the hospital and be observed until the side effects have gone away. Other than that, treatment will be given on an outpatient basis.
During treatment you will have routine blood tests (about 1 tablespoon) once a week. The treatment will take about 8 weeks to be completed. You will be taken off study if your disease gets worse or if the side effects become too severe.
After treatment is over, you will have a complete physical exam, including routine blood tests (about 2 tablespoons). A bone marrow sample will be taken. Imaging studies (such as a chest x-ray or CT scans) may be repeated to evaluate the effect of the treatment. If this treatment has worked for you, your doctor may advise you to receive it again for a second time.
You will then return for post-treatment evaluation every 6 months for 1 year and then once a year for 3 years or until you start a new treatment.
This is an investigational study. GM-CSF and rituximab have been approved by the FDA for clinical use. Their use together in this study, however, is experimental. Up to 130 patients may take part in this study. All patients will be enrolled at M.D. Anderson Cancer Center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated and Relapsed - Group 1 | Experimental | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. |
|
| Treated and High-Risk for Progression - Group 2 | Experimental | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. |
|
| 70 Years of Age and Refused Chemo - Group 3 | Experimental | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GM-CSF (Sargramostim) | Drug | 250 mcg injection under the skin, three times a week for eight weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Overall Response Rate - Complete Response (CR) + Partial Response (PR). CR is the absence of Lymphocyte infiltrates on biopsy, <30% Lymphocytes on Bone Marrow Aspirate, Lymphocytes < 4,000ul , Hemoglobin >11.0 g/dl , Platelets >1000,000/ul, Polymorphonuclear neutrophils (PMN) >1,500/ul, Liver/Spleen not palpable, Nodes none. PR is <30% Lymphocytes with residual disease on biopsy for nodular PR, Lymphocytes >50% decrease, Hemoglobin (un-transfused) > 11.0 g/dl or >50% improvement from baseline, Platelets > 100,000/ul or 50% improvement from baseline, PMN >1,500 ul or 50% improvement from baseline, Liver/Spleen >/= 50% decrease, Nodes >/= 50%. | Blood tests once a week during 8 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
1) None.
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra Ferrajoli, 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 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: October 2004 through January 2007. Of the 130 participants recruited, 119 participants were recruited at The University of Texas (UT) MD Anderson Cancer Center, 6 at The University of California San Diego, and 5 participants were recruited at Dana Farber Cancer Institute.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated and Relapsed - Group 1 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks |
| FG001 | Untreated and High-Risk for Progression - Group 2 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks |
| FG002 | 70 Years of Age and Refused Chemo - Group 3 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated and Relapsed - Group 1 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Overall Response Rate | Overall Response Rate - Complete Response (CR) + Partial Response (PR). CR is the absence of Lymphocyte infiltrates on biopsy, <30% Lymphocytes on Bone Marrow Aspirate, Lymphocytes < 4,000ul , Hemoglobin >11.0 g/dl , Platelets >1000,000/ul, Polymorphonuclear neutrophils (PMN) >1,500/ul, Liver/Spleen not palpable, Nodes none. PR is <30% Lymphocytes with residual disease on biopsy for nodular PR, Lymphocytes >50% decrease, Hemoglobin (un-transfused) > 11.0 g/dl or >50% improvement from baseline, Platelets > 100,000/ul or 50% improvement from baseline, PMN >1,500 ul or 50% improvement from baseline, Liver/Spleen >/= 50% decrease, Nodes >/= 50%. | Posted | Count of Participants | Participants | Blood tests once a week during 8 weeks of treatment. |
|
Adverse events captured from the time of participant consent and will be followed to resolution or stabilization. Adverse events reported during each treatment course, up to 8 weeks
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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 | Treated and Relapsed - Group 1 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alessandra Ferrajoli, MD/Professor | The University of Texas MD Anderson Cancer Center | 713-792-7734 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C081222 | sargramostim |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
| Rituximab | Drug | 375 mg/m^2 administered intravenously once weekly for four weeks |
|
|
| BG001 | Untreated and High-Risk for Progression - Group 2 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks |
| BG002 | 70 Years of Age and Refused Chemo - Group 3 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Untreated and High-Risk for Progression - Group 2 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks |
| OG002 | 70 Years of Age and Refused Chemo - Group 3 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks |
|
|
| 3 |
| 50 |
| 5 |
| 50 |
| 21 |
| 50 |
| EG001 | Untreated and High-Risk for Progression - Group 2 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks | 0 | 40 | 3 | 40 | 16 | 40 |
| EG002 | 70 Years of Age and Refused Chemo - Group 3 | Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks. GM-CSF (Sargramostim): 250 mcg injection under the skin, three times a week for eight weeks. Rituximab: 375 mg/m^2 administered intravenously once weekly for four weeks | 1 | 40 | 4 | 40 | 15 | 40 |
| Neutropenic Fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemolysis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ischemia | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |