Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells
Condition: Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Carboplatin; Etoposide; Filgrastim; Ifosfamide; Leukapheresis; Plerixafor; Rituximab
Intervention description: Given IV; Given IV; Given SC; Given IV; Given through catheter; Given SC; Given IV
Intervention MeSH terms: Plerixafor; Rituximab; Antineoplastic Agents, Immunological; Carboplatin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Podophyllotoxin; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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