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

Completed · Phase 2

Conditions studied: Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT01097057

Run by

Fred Hutchinson Cancer Center

People needed

20

Starts

2010-11-09

Expected to finish

2017-12-26

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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