Title A Study of Hematopoietic Stem Cell Supermobilization in Patients with Non-Hodgkin Lymphoma
IRB CASE 2410
Hospital Main Campus
Disease Blood & Marrow Transplant (BMT), Lymphoma, Lymphoma, Non - Hodgkin
- To determine whether the addition of plerixafor improves the proportion of patients with lymphoma who collect ≥ 8 x 106 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 106 CD34+ cells/kg have a 15% one year survival advantage relative to the historical estimate of 68% among patients mobilizing ≥ 2 but < 8 x 106 CD34+ cells/kg with etoposide and G-CSF.
- To demonstrate that patients receiving ≥ 8 x 106 CD34+ cells/kg have more rapid neutrophil and platelet recovery and earlier hospital discharge than those receiving < 8 x 106 CD 34+ cells/kg.
- To compare overall survival and progression-free survival between patients receiving ≥8 x 106 CD34+ cells/kg and those receiving <8 x 106 CD34+ cells/kg.
- To compare number of days of apheresis required to achieve goal, transfusion requirements, hospitalization costs, need for remobilization between groups.
- To evaluate whether peripheral CD34+ cell count correlates with graft content of CD34+ cells.
- 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
- 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
- Negative for HIV
- Prior to the start of mobilization, must have:
- Absolute neutrophil count of ≥ 1.2 x 109/L
- Platelet count of ≥ 100 x 109/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 and for at least 3 months following last plerixafor dose. 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 previous radiation of the pelvic area
- Have had prior radioimmunotherapy
- Have received experimental therapy within 2 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