Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and
      granulocyte colony-stimulating factor (G-CSF or generic name filgrastim) is better than G-CSF
      alone to mobilize and collect the optimal number of stem cells in non-Hodgkin's lymphoma
      patients for autologous transplantation.
    

Detailed description: 
      A peripheral stem cell transplant may be able to replace blood-forming cells that were
      destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used
      to cause the growth and mobilization of stem cells from bone marrow to peripheral blood,
      which can then be collected from the peripheral blood by a process called apheresis.
      Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral
      blood, possibly allowing for a more rapid collection of a larger number of stem cells from
      the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery
      times after high dose chemotherapy followed with stem cell transplantation. This study is
      intended to determine whether the combination of plerixafor with filgrastim is better than
      filgrastim alone in helping non-Hodgkin's lymphoma patients collect at least 5 million stem
      cells in four or less apheresis sessions.

      This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
      acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
    

Intervention name(s): Granulocyte colony-stimulating factor plus plerixafor; Granulocyte colony-stimulating factor plus placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.; Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Other intervention name(s): AMD3100; Mozobil
Intervention MeSH terms: Plerixafor; Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-Hodgkin's lymphoma; Stem cell mobilization