NCT01097057

Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells

Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Etoposide	Given IV
BIOLOGICAL	Filgrastim	Given SC
DRUG	Ifosfamide	Given IV
PROCEDURE	Leukapheresis	Given through catheter
DRUG	Plerixafor	Given SC
BIOLOGICAL	Rituximab	Given IV

Timeline

• Start date: 2010-11-09
• Primary completion: 2013-09-01
• Completion: 2017-12-26
• First posted: 2010-04-01
• Last updated: 2018-01-23
• Results posted: 2017-07-02

Locations

1 site across 1 country: United States