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
• Trial end date: 2017-12-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Carboplatin; Etoposide; Etoposide phosphate; Ifosfamide; Immunoglobulins; Isophosphamide mustard; JM 3100; Lenograstim; Plerixafor; Podophyllotoxin; Rituximab

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