Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
NCT ID: NCT01097057
Last Updated: 2018-01-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2010-11-09
2017-12-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Interventions
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Carboplatin
Given IV
Etoposide
Given IV
Filgrastim
Given SC
Ifosfamide
Given IV
Leukapheresis
Given through catheter
Plerixafor
Given SC
Rituximab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction at rest \>= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram
* Bilirubin =\< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 times the upper limit of normal
* Creatinine clearance (calculated creatinine clearance is permitted) \> 50 mL/min
* Signed informed consent
* Planned autologous transplant within 3 months after collection of peripheral blood stem cells (PBSCs)
Exclusion Criteria
* Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
* Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent \> 5 years previously will be allowed
* Pregnant or breastfeeding
* Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
* Prior autologous or allogeneic hematopoietic stem cell transplant (HSCT)
* Human immunodeficiency virus (HIV) positive
* Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
* Hepatitis B carriers
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Leona Holmberg
Principal Investigator
Principal Investigators
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Leona Holmberg
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2009-01562
Identifier Type: REGISTRY
Identifier Source: secondary_id
2310.00
Identifier Type: OTHER
Identifier Source: secondary_id
2310.00
Identifier Type: -
Identifier Source: org_study_id
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