Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/25/2018 |
| Start Date: | November 9, 2010 |
| End Date: | December 26, 2017 |
Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor
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.
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.
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.
Inclusion Criteria:
- Diagnosis of CD20+ non-Hodgkin's lymphoma
- 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:
- Karnofsky performance score < 70%
- 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
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