The Effect of Rituximab on Mobilization With AMD3100 (Plerixafor) Plus G-CSF in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD)
Condition: Non-Hodgkin Lymphoma; Hodgkin Disease
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one
      of 2 arms based on the immunophenotype of their lymphoma.

      (A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte
      colony-stimulating factor (G-CSF) and plerixafor.

      (B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and
      plerixafor. They will receive a weekly dose of rituximab beginning 1 week prior to, and
      continuing until 2 weeks after, the first dose of G-CSF.

      Participants in both groups will receive G-CSF twice daily for 4 days. In the evening on Day
      4, a dose of plerixafor will be administered. Apheresis will be initiated the next morning.
      Participants will continue to receive G-CSF twice daily and to receive the evening dose of
      plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until
      ≥5*10^6 CD34+ cells/kg are collected.

      Participants who are transplanted will be monitored for the time to polymorphonuclear
      leukocytes (PMN), platelets (PLT), and lymphocyte engraftment. Follow-up assessments will be
      done at 100 days, and 6 and 12 months post-transplantation.
    

Detailed description: 
      This is a single-center, 2-arm, non-randomized, open-label study to evaluate the safety of
      plerixafor when used in combination with rituximab (Rituxan®) and granulocyte
      colony-stimulating factor (G-CSF) in patients with relapsed or refractory Hodgkin disease
      (HD) or non-Hodgkin lymphoma (NHL).

      Participants will be assigned to one of 2 arms based on the immunophenotype of their
      lymphoma.

      (A)Participants with CD20(-) lymphoma will undergo mobilization with G-CSF and plerixafor.

      (B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and
      plerixafor. They will receive a weekly dose of 375 mg/m2 rituximab by intravenous (iv)
      infusion beginning 1 week prior to, and continuing until 2 weeks after, the first dose of
      G-CSF.

      Participants in both groups will receive 7.5 µg/kg G-CSF twice daily (morning and evening)
      for 4 days. In the evening (approximately 10:00 pm) on Day 4, a dose of plerixafor (240
      µg/kg) will be administered. Apheresis will be initiated the next morning, approximately 10
      to 11 hours after plerixafor is given. Participants will continue to receive G-CSF twice
      daily and to receive the evening dose of plerixafor followed by apheresis the next morning
      for up to a total of 4 aphereses or until ≥5*10^6 CD34+ cells/kg are collected.

      Participants with an adequate number of autologous peripheral blood stem cells (PBSCs)
      collected by apheresis will be admitted to the study center for the administration of
      high-dose chemotherapy and autologous transplantation. After transplantation, the times to
      PMN, PLT, and lymphocyte engraftment will be measured. Participants will remain hospitalized
      until they achieve an absolute granulocyte count of >500/µl in the peripheral blood. Graft
      durability will be assessed at 100 days, and 6 and 12 months post-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; G-CSF plus plerixafor; rituximab
Intervention type(s): Drug; Drug; Biological
Intervention description(s): Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (sc) injection. 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 (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.; Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (SC) injection. 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 (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥5*10^6 CD34+ cells/kg were collected.; Participants were given a weekly dose of rituximab 375mg/m2 by intravenous infusion for 1 week prior to and continuing until 2 weeks after the first dose of G-CSF.
Other intervention name(s): AMD3100; Mozobil; Mozobil; AMD3100; Rituxan; MabThera
Intervention MeSH terms: Plerixafor; Rituximab; Lenograstim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AMD3100; stem cell mobilization; autologous transplant; Non-Hodgkin Lymphoma; Hodgkin Disease