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A Study of Hematopoietic Stem Cell Supermobilization in Patients with Non-Hodgkin Lymphoma
|Blood & Marrow Transplant (BMT)
|Lymphoma, Non - Hodgkin
- To determine whether the addition of plerixafor improves the proportion of patients with lymphoma who collect ≥ 8 x 10^6 CD34+ cells/kg within two days by 25% compared to the historical estimate of 42% with etoposide and G-CSF.
- To determine whether patients achieving collection of ≥ 8 x 10^6 CD34+ cells/kg have a 15% one year survival advantage relative to the historical estimate of 68% among patients mobilizing ≥ 2 but < 8 x 10^6 CD34+ cells/kg with etoposide and G-CSF.
- Participants must be 18 years of age or older but not more than 78 years old
- Have biopsy-confirmed non-Hodgkin lymphoma, of any type
- Be in first or second complete or partial remission
- Must be eligible for autologous transplantation according to institutional guidelines
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Karnofsky performance status of 70 to 100
- ≥ 3 weeks since last cycle of chemotherapy
- Negative for HIV
- Prior to the start of Mobilization, must have:
- White blood cell count ≥ 2.5 x 10^9/L
- Absolute neutrophil count of ≥ 1.2 x 10^9/L
- Platelet count of ≥ 100 x 10^9/L
- Creatinine clearance ≥ 30 mL/minute
- All patients must be able to comprehend and sign informed consent.
- If childbearing potential must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization. Female patients will undergo pregnancy test prior to stem cell mobilization therapy.
- Have had previous transplants and/or prior mobilization attempts
- Have evidence of progressive non-Hodgkin lymphoma
- Have evidence of bone marrow involvement of lymphoma at time of transplant staging
- Had evidence of active CNS involvement
- Have had > 3 prior regimens for treatment of non-Hodgkin lymphoma
- Have had previous radiation of the pelvic area
- Have had prior radioimmunotherapy
- Have received G-CSF or other growth factors within 14 days of the etoposide dose.
- Have received experimental therapy within 4 weeks of enrollment
- Be currently enrolled in another investigational protocol
- Have prior history of other malignancies, excluding basal cell carcinoma or squamous cell carcinoma of the skin
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