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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-07085 | |||
| BRLX-MSKCC-07-085 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant helps stop the growth of cancer cells by stopping them from dividing or by killing them. An autologous stem cell transplant may be able to replace the blood-forming cells that were destroyed by chemotherapy. GM-CSF may increase the number of immune cells found in bone marrow or peripheral blood. Giving a monoclonal antibody, such as rituximab, after the transplant may find any remaining cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving GM-CSF together with rituximab after autologous stem cell transplant may be an effective treatment for follicular non-Hodgkin lymphoma.
PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab after autologous stem cell transplant works in treating patients with relapsed or primary refractory follicular non-Hodgkin lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After the completion of study treatment, patients are followed periodically for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GM-CSF and Rituximab After Autologous Stem Cell Transplant | Experimental | GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, administered on alternate days. Thus, 24 doses of GM-CSF will be administered. Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF; rituximab. The second course of GM-CSF and rituximab will be administered approximately 22-26 weeks (day +154 to +182) after ASCT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
| ||
| rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Rate | after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as:
| up to 3 years |
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DISEASE CHARACTERISTICS:
Histologic diagnosis of grade 1, 2, 3, or transformed follicular lymphoma
Achieved a complete or partial response to last salvage therapy
One of the following disease statuses must have been present prior to receiving salvage therapy
Minimum of 2 x 10^6 CD34+ cells/kg cryopreserved and available for hematopoietic stem cell support
No leptomeningeal disease or brain parenchyma involvement
PATIENT CHARACTERISTICS:
Cardiac ejection fraction > 50%
Adjusted diffusing capacity ≥ 50% of the predicted value on pulmonary function testing
Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mL/min
ANC > 1,000/μL
Platelet count > 50,000/μL
Total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL if Gilbert's disease is suspected)
Not pregnant or breast-feeding
Fertile patients must use an acceptable form of birth control
HIV I or II negative
No acute or chronic hepatitis B
No active hepatitis C
No medical illness (unrelated to non-Hodgkin lymphoma), including malignancies that, in the opinion of the attending physician and/or principal investigator, would preclude study treatment
No other malignancy within the past 5 years except curatively treated cutaneous basal cell or squamous cell carcinoma or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
No more than 3 prior anti-lymphoma regimens, inclusive of the salvage therapy
No prior autologous or allogeneic hematopoietic stem cell transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Craig Moskowitz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Matthew Matasar, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Relapsed Follicular Lymphoma Patients | Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
|
| sargramostim | Biological |
|
| carmustine | Drug |
|
| cytarabine | Drug |
|
| etoposide | Drug |
|
| melphalan | Drug |
|
| autologous hematopoietic stem cell transplantation | Procedure |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Relapsed Follicular Lymphoma Patients | Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma |
| 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 | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Progression-free Survival Rate | after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as:
| Posted | Mean | Full Range | years | up to 3 years |
|
|
|
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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 | Relapsed Follicular Lymphoma Patients | Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma | 2 | 13 | 13 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Inf norm ANC/gr1/2 | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Obstruction, GI- Gallbladder | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Buttock | General disorders | CTC-3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Amylase | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Moskowitz | Memorial Sloan Kettering Cancer Center | 212-639-7992 | moskowic@mskcc.org |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D000069283 | Rituximab |
| C081222 | sargramostim |
| D002330 | Carmustine |
| D003561 | Cytarabine |
| D005047 | Etoposide |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| 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 |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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