AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts
Condition: Autologous Stem Cell Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety, efficacy, and pharmacokinetics (PK) of plerixafor given in
      addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood
      stem cells (PBSCs) for autologous transplantation in patients who would benefit from an
      autologous stem cell transplant but have failed previous collections or collection attempts
      with a mobilization regimen of G-CSF alone, chemotherapy and G-CSF, or any other conventional
      therapy including cytokines, chemotherapy and cytokines and bone marrow harvests.

      The only change to standard of care of a mobilization regimen that includes G-CSF is the
      addition of a dose of AMD3100 (plerixafor) on the evening prior to each day of apheresis.

      Efficacy outcomes include quantification of CD34+ cells in the apheresis product and
      assessment of successful polymorphonuclear leukocyte (PMN) and platelet (PLT) engraftment
      after transplantation. PK outcomes include analysis of repeated doses of plerixafor.
    

Detailed description: 
      This is a Phase 2, multicenter, prospective, open-label study. Once 70 patients have
      enrolled, subsequent patients enrolled should have a diagnosis of lymphoma. Patients who
      would benefit from an autologous stem cell transplant, who have failed previous collections
      or collection attempts with a mobilization regimen of granulocyte colony-stimulating factor
      (G-CSF) alone, chemotherapy and G-CSF, or any other conventional therapy including cytokines,
      chemotherapy and cytokines and bone marrow harvests, and who meet the inclusion/exclusion
      criteria are eligible to receive plerixafor as outlined in this protocol. The only change to
      standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of
      plerixafor on the evening prior to each day of apheresis.

      Patients will undergo mobilization with G-CSF (10 µg/kg) for 4 days. On Day 4, plerixafor
      (240 µg/kg) will be administered in the evening prior to the first apheresis and each
      subsequent evening prior to apheresis thereafter, such that there is a 10 to 11 hour interval
      between dosing and the initiation of apheresis. Patients will continue to receive G-CSF on
      each day of apheresis. Patients will undergo a minimum of 2 and a maximum of 7 aphereses or
      until ≥2*10^6 CD34+ cells/kg are collected, whichever occurs first. In addition, the
      mobilization of NHL tumor cells and the pharmacokinetics of repeat doses of plerixafor will
      be examined.

      After the last apheresis has been completed, or after the patient has collected ≥2*10^6 CD34+
      cells/kg, he/she will be treated with high-dose chemotherapy in preparation for
      transplantation. Patients will be transplanted with cells obtained from the G-CSF with
      plerixafor mobilization regimen. In the event that the minimum number of ≥2*10^6 cells for
      transplantation are not obtained from the first mobilization with plerixafor, cells may be
      retained and pooled for transplantation with those from a second mobilization with plerixafor
      (or from prior mobilization with other agents), at the investigator's discretion. If a second
      mobilization with plerixafor is attempted, a minimum rest interval of one week should be
      allowed between the last apheresis of the first regimen and the first dose of G-CSF of the
      second. The number of CD34+ cells mobilized in the peripheral blood (PB), collected in the
      apheresis product, and the number of apheresis sessions performed will be measured. Success
      of the transplantation will be evaluated by the time to engraftment of polymorphonuclear
      leukocytes (PMN) and platelets (PLT). Participants will be assessed for durability of their
      transplant for 12 months after transplantation.

      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): G-CSF plus plerixafor
Intervention type(s): Drug
Intervention description(s): Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
Other intervention name(s): AMD3100; Mozobil
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Non-Hodgkin's Lymphoma; autologous transplantation; AMD3100; stem cell mobilization; plerixafor