Details

Details

Title A Study of Hematopoietic Stem Cell Supermobilization in Patients with Non-Hodgkin Lymphoma

IRB CASE2410

CC CC1005

Hospital Main Campus

Stage N/A

Phase N/A

Disease Blood & Marrow Transplant (BMT), Lymphoma, Lymphoma - Non - Hodgkin

Description

Description

Primary Objectives
  1. 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.
  2. 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.
Secondary Objectives
  1. 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.
  2. 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.
  3. To compare number of days of apheresis required to achieve goal, transfusion requirements, hospitalization costs, need for remobilization between groups.
  4. To evaluate whether peripheral CD34+ cell count correlates with graft content of CD34+ cells.
    5. Inclusion Criteria

    Inclusion Criteria

    1. Participants must be 18 years of age or older but not more than 78 years old
    2. Have biopsy-confirmed non-Hodgkin lymphoma, of any type
    3. Must be eligible for autologous transplantation according to institutional guidelines
    4. Eastern Cooperative Oncology Group performance status of 0 or 1
    5. Karnofsky performance status of 70 to 100
    6. Negative for HIV
    7. 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
    8. All patients must be able to comprehend and sign informed consent.
    9. 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.
    Exclusion Criteria

    Exclusion Criteria

    1. Have had previous transplants and/or prior mobilization attempts
    2. Have evidence of progressive non-Hodgkin lymphoma
    3. Have evidence of bone marrow involvement of lymphoma at time of transplant staging
    4. Had evidence of active CNS involvement
    5. Have had previous radiation of the pelvic area
    6. Have had prior radioimmunotherapy
    7. Have received experimental therapy within 2 weeks of enrollment
    8. Be currently enrolled in another investigational protocol
    9. Have prior history of other malignancies, excluding basal cell carcinoma or squamous cell carcinoma of the skin