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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Etoposide
* Biological: Filgrastim
* Drug: Ifosfamide
* Procedure: Leukapheresis
* Drug: Plerixafor
* Biological: Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (rituximab, etoposide, carboplatin, ifosfamide)<br>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. | Drug: Carboplatin<br>* Given IV<br>* Other names: Ribocarbo;Drug: Etoposide<br>* Given IV<br>* Other names: VP-16-213;Biological: Filgrastim<br>* Given SC<br>* Other names: Tevagrastim;Drug: Ifosfamide<br>* Given IV<br>* Other names: Z-4942;Procedure: Leukapheresis<br>* Given through catheter<br>* Other names: Therapeutic Leukopheresis;Drug: Plerixafor<br>* Given SC<br>* Other names: SDZ SID 791;Biological: Rituximab<br>* Given IV<br>* Other names: RTXM83;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |