Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Granulocyte colony-stimulating factor plus plerixafor; Granulocyte colony-stimulating factor plus placebo
Intervention description: 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.
Intervention MeSH terms: Plerixafor; Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: Non-Hodgkin's lymphoma; Stem cell mobilization

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.
    

Eligibility criteria:

        Inclusion Criteria (Abbreviated List):

          -  Non-Hodgkin's lymphoma in first or second complete or partial remission

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  White Blood Cell count (WBC) > 2.5*10^9/L

          -  Platelet (PLT) > 100*10^9/L

        Exclusion Criteria (Abbreviated List):

          -  Failed previous stem cell collection

          -  Prior autologous or allogeneic transplant

          -  Brain metastases or bone marrow involvement > 20%

          -  Radiation to pelvis

          -  Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or
             other conduction abnormality