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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01281 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE2410 | Other Identifier | Case Comprehensive Cancer Center | |
| P30CA043703 | U.S. NIH Grant/Contract | View source |
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Slow Accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies etoposide, filgrastim and plerixafor in improving stem cell mobilization in patients with non-Hodgkin lymphoma. Giving colony-stimulating factors, such as filgrastim, and plerixafor and etoposide together helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored.
PRIMARY OBJECTIVES:
I. To determine whether the addition of plerixafor improves the proportion of patients with lymphoma who collect >= 8 x 10^6 cluster of differentiation (CD)34+ cells/kg within two days by 25% compared to the historical estimate of 42% with etoposide and G-CSF (filgrastim).
II. To determine whether patients achieving collection of >= 8 x 10^6 CD34+ cells/kg have a 15% one year survival advantage relative to the historical estimate of 68% among patients mobilizing >= 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and G-CSF.
SECONDARY OBJECTIVES:
I. To demonstrate that patients receiving >= 8 x 10^6 CD34+ cells/kg have more rapid neutrophil and platelet recovery and earlier hospital discharge than those receiving < 8 x 10^6 CD 34+ cells/kg.
II. To compare overall survival and progression-free survival between patients receiving >= 8 x 10^6 CD34+ cells/kg and those receiving < 8 x 10^6 CD34+ cells/kg.
III. To compare number of days of apheresis required to achieve goal, transfusion requirements, hospitalization costs, need for remobilization between groups.
IV. To evaluate whether peripheral CD34+ cell count correlates with graft content of CD34+ cells.
OUTLINE:
Patients receive etoposide intravenously (IV) over 4 hours on day 0, filgrastim subcutaneously (SC) once daily (QD) beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician.
After completion of study treatment, patients are followed up at 28 days and then for at least 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (stem cell supermobilization) | Experimental | Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plerixafor | Drug | Given SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Collection Using Plerixafor, Etoposide, and Filgrastim | Number of participants able to collect equal to or more than 8 x 10^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10^6 CD34+ cells/kg are defined as normal mobilizers. | Within 2 days of apheresis |
| Progression-free Survival | The number of participants of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year | Up to 1 year post-transplant |
| Overall Survival | Number of participants who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant | Up to 1 year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Neutrophil Recovery in Super Mobilizers and Normal Mobilizers | Neutrophil recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg entered as the mean cell count of super mobilizers and normal mobilizers. | Up to 28 days post treatment |
| Platelet Recovery in Super Mobilizers and Normal Mobilizers |
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Inclusion Criteria:
Have biopsy-confirmed non-Hodgkin lymphoma, of any type
Must be eligible for autologous transplantation according to institutional guidelines
Eastern Cooperative Oncology Group performance status of 0 or 1
Karnofsky performance status of 70 to 100
Negative for human immunodeficiency virus (HIV)
prior to the start of mobilization, subjects must have:
All patients must be able to comprehend and sign informed consent
If childbearing potential must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization and for at least 3 months following last plerixafor dose; female patients will undergo pregnancy test prior to stem cell mobilization therapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Navneet Majhail, MD | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Stem Cell Supermobilization) | Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| filgrastim | Biological | Given SC |
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| etoposide | Drug | Given IV |
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| leukapheresis | Procedure | Undergo apheresis |
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Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg. |
| Up to 28 days post treatment |
| Length of Hospital Stay in Super Mobilizers and Normal Mobilizers | Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg. | Up to 28 days post treatment |
| Progression-free Survival in Supermobilizers and Normal Mobilizers | Percentage of participants who were alive and free of progression 1 year after transplant (PFS) | Up to 1 year post-transplant |
| Overall Survival in Supermobilizers and Normal Mobilizers | Percentage of participants who were alive 1 year after transplant (OS) | Up to 1 year post-transplant |
| Number of Days of Apheresis Required | Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers | Up to 28 days post treatment |
| Number of Transfusion Requirements | Number of transfusions (number of packed red blood cells and platelet transfusions required from day 0 to +28 post-transplant) in supermobilizers and normal mobilizers | Up to 28 days post treatment |
| Need for Remobilization | Number of participants that needed remobilization in supermobilizers and normal mobilizers. Remobilization can be described as follows: The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as "mobilization failure". For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time ("remobilization"). The need to do a second 'mobilization' attempt is not ideal. | Up to 28 days post treatment |
| Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells | Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation. | Up to 28 days post treatment |
| COMPLETED |
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| NOT COMPLETED |
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Participants enrolled and received intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Stem Cell Supermobilization) | Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | Collection Using Plerixafor, Etoposide, and Filgrastim | Number of participants able to collect equal to or more than 8 x 10^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10^6 CD34+ cells/kg are defined as normal mobilizers. | All participants that went on study | Posted | Count of Participants | Participants | Within 2 days of apheresis |
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| ||||||||||||||||||||||||||||||||||||
| Primary | Progression-free Survival | The number of participants of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year | Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg | Posted | Count of Participants | Participants | Up to 1 year post-transplant |
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| |||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival | Number of participants who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant | Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg | Posted | Count of Participants | Participants | Up to 1 year post-transplant |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Neutrophil Recovery in Super Mobilizers and Normal Mobilizers | Neutrophil recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg entered as the mean cell count of super mobilizers and normal mobilizers. | All participants that had some mobilization | Posted | Mean | Standard Deviation | K/ul | Up to 28 days post treatment |
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| Secondary | Platelet Recovery in Super Mobilizers and Normal Mobilizers | Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg. | All participants that had some mobilization | Posted | Mean | Standard Deviation | percentage of change | Up to 28 days post treatment |
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| Secondary | Length of Hospital Stay in Super Mobilizers and Normal Mobilizers | Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg. | All participants that had some mobilization | Posted | Mean | Standard Deviation | days | Up to 28 days post treatment |
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| Secondary | Progression-free Survival in Supermobilizers and Normal Mobilizers | Percentage of participants who were alive and free of progression 1 year after transplant (PFS) | All participants that had some mobilization | Posted | Number | percent of participants | Up to 1 year post-transplant |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival in Supermobilizers and Normal Mobilizers | Percentage of participants who were alive 1 year after transplant (OS) | All participants that had some mobilization | Posted | Number | percent of participants | Up to 1 year post-transplant |
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| Secondary | Number of Days of Apheresis Required | Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers | Participants that were mobilized | Posted | Mean | Standard Deviation | days | Up to 28 days post treatment |
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| Secondary | Number of Transfusion Requirements | Number of transfusions (number of packed red blood cells and platelet transfusions required from day 0 to +28 post-transplant) in supermobilizers and normal mobilizers | Participants that were mobilized | Posted | Mean | Standard Deviation | transfusions | Up to 28 days post treatment |
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| Secondary | Need for Remobilization | Number of participants that needed remobilization in supermobilizers and normal mobilizers. Remobilization can be described as follows: The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as "mobilization failure". For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time ("remobilization"). The need to do a second 'mobilization' attempt is not ideal. | Participants that were mobilized | Posted | Count of Participants | Participants | Up to 28 days post treatment |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells | Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation. | No data collected for this outcome due to low accrual | Posted | Up to 28 days post treatment |
|
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Up to 1 year post-transplant
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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 (Stem Cell Supermobilization) | Patients receive etoposide IV over 4 hours on day 0, filgrastim SC QD beginning day 1, and plerixafor SC 15-18 hours prior to apheresis. Patients unable to achieve target collection of >= 8 x 10^6 CD34+ cells/kg receive another dose of plerixafor followed by apheresis. Following the second apheresis, patients achieving =< 2 x 10^6 CD34+ cells/kg may continue filgrastim with plerixafor and continue collection according to the attending physician. plerixafor: Given SC filgrastim: Given SC etoposide: Given IV leukapheresis: Undergo apheresis | 0 | 25 | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Navneet Majhail | Case Comprehensive Cancer Center | 216-444-2199 | majhain@ccf.org |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007943 | Leukemia, Hairy Cell |
| D054066 | Leukemia, Large Granular Lymphocytic |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| 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 |
| D000072281 | Lymphadenopathy |
| D016393 | Lymphoma, B-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015458 | Leukemia, T-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D005047 | Etoposide |
| D007937 | Leukapheresis |
| ID | Term |
|---|---|
| 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 |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| 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 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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