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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01562 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2310.00 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.
OBJECTIVES:
I. Evaluate the efficacy of combining RICE (rituximab-ifosfamide-carboplatin-etoposide regimen [R-ICE regimen]), G-CSF, and plerixafor to collect autologous peripheral blood stem cell (PBSC) for non-Hodgkin's lymphoma (NHL) patients by: the number of days of apheresis required to reach >= 5 x 10^6 cluster of differentiation (CD)34 cells/kg and by the total number of CD34 cells/kg collected in a maximum of 4 days if >= 5 x 10^6 CD34 cells/kg is not obtained.
OUTLINE:
Patients receive rituximab intravenously (IV) on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive filgrastim subcutaneously (SC) once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.
After completion of study treatment, patients are followed up at 30 days and then periodically for up to 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (rituximab, etoposide, carboplatin, ifosfamide) | Experimental | Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy) | Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis. | One Month |
| Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days | Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures. | Up to Four Apheresis Days |
| Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg | Number of participants requiring one or two apheresis collection days to reach collection goal. | Up to Four Apheresis Days |
| Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days | Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days | Up to Four Apheresis Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leona Holmberg | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected. Carboplatin: Given IV Etoposide: Given IV Filgrastim: Given SC Ifosfamide: Given IV Leukapheresis: Given through catheter Plerixafor: Given SC Rituximab: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Etoposide | Drug | Given IV |
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| Filgrastim | Biological | Given SC |
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| Ifosfamide | Drug | Given IV |
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| Leukapheresis | Procedure | Given through catheter |
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| Plerixafor | Drug | Given SC |
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| Rituximab | Biological | Given IV |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected. Carboplatin: Given IV Etoposide: Given IV Filgrastim: Given SC Ifosfamide: Given IV Leukapheresis: Given through catheter Plerixafor: Given SC Rituximab: Given IV |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy) | Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis. | Posted | Count of Participants | Participants | One Month |
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| Primary | Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days | Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures. | Posted | Count of Participants | Participants | Up to Four Apheresis Days |
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| Primary | Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg | Number of participants requiring one or two apheresis collection days to reach collection goal. | Posted | Count of Participants | Participants | Up to Four Apheresis Days |
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| Primary | Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days | Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days | Note: No patients were in this category. | Posted | Count of Participants | Participants | Up to Four Apheresis Days |
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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 | Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide) | Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected. Carboplatin: Given IV Etoposide: Given IV Filgrastim: Given SC Ifosfamide: Given IV Leukapheresis: Given through catheter Plerixafor: Given SC Rituximab: Given IV | 5 | 20 | 2 | 20 | 3 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment | No treatment related deaths |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | No treatment related deaths |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DVT | Vascular disorders | Systematic Assessment | Non-hematological toxicity. Grading of toxicity according NCI-CTCAE version 3. Asymptomatic line-associated DVT requiring therapeutic anticoagulant. |
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| Cellulitis | Infections and infestations | Systematic Assessment | Non-hematological toxicity. Grading of toxicity according NCI-CTCAE version 3. Cellulitis at Hickman site |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment | Non-hematological toxicity. Grading of toxicity according NCI-CTCAE version 3. One patient had both hyperglycemia and cellulitis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leona A. Holmberg | Fred Hutchinson Cancer Research Center | 206-667-6447 | lholmber@fredhutch.org |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| 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 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D007069 | Ifosfamide |
| D007937 | Leukapheresis |
| C088327 | plerixafor |
| C049051 | ferric pyrophosphate |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
| D002241 | Carbohydrates |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| 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 |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016238 | Cytapheresis |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
| D047589 | Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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