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

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

Research Study Number       2310.00
    
Principal Investigator       Leona Holmberg, MD, PhD
    
Phase       II

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Research Study Description

This phase II trial is studying how well giving rituximab, ICE combination chemotherapy, and 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 filgrastim (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

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- Diagnosis of CD20+ non-Hodgkin's lymphoma

- Cardiac: left ventricular ejection fraction at rest >= 50% demonstrated by MUGA or echocardiogram

- Hepatic: bilirubin =< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome) and ALT and AST =< 3 times the upper limit of normal

- Renal: creatinine clearance (calculated creatinine clearance is permitted) > 50 mL/min

- Signed informed consent

- Planned autologous transplant within 3 months after collection of PBSCs

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- -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 HSCT

- HIV positive

- Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study

- Hepatitis B carriers

Other exclusion criteria may apply.



Research Study Number       2310.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Burkitt's Lymphoma; Hematologic Malignancies; Lymphoma; Non-Hodgkin's Lymphoma (NHL)

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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