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
Intervention: G-CSF plus plerixafor; G-CSF plus plerixafor; rituximab
Intervention description: 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.
Intervention MeSH terms: Plerixafor; Rituximab; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: AMD3100; stem cell mobilization; autologous transplant; Non-Hodgkin Lymphoma; Hodgkin Disease

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.
    

Eligibility criteria:

        Inclusion Criteria (abbreviated list):

          -  Histological diagnosis of diffuse large cell lymphoma, B-cell, T-cell or anaplastic
             histologies; peripheral T-cell lymphoma; small non-cleaved Burkitt-like lymphoma; or
             Hodgkin disease. NOTE: Participants diagnosed at a facility outside of Emory
             University will have their diagnosis confirmed by Emory University pathologists prior
             to being enrolled in this study.

          -  Eligible for autologous transplantation.

          -  History of relapse of lymphoma following initial treatment with an
             anthracycline-containing regimen or disease that is refractory or progresses during
             initial therapy with an anthracycline-containing regimen.

          -  Immunophenotyping of the lymphoma at the time of diagnosis or relapse using flow
             cytometry or immunohistochemistry.

          -  Presence of clinically- and/or radiologically-documented, measurable, and/or evaluable
             disease at the time of relapse.

          -  Received 2 cycles of salvage chemotherapy.

          -  Complete response (i.e., normal physical examination, lymph nodes, lymph node masses,
             and bone marrow) or a partial response (i.e., decrease of ≧50% in the size of lymph
             nodes or lymph node masses or decrease in size of liver/spleen on physical exam) to at
             least one cycle of a salvage chemotherapy regimen.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

          -  Absolute granulocytes count ≧1.0*10^9/l.

          -  Platelet count ≧75*10^9/l.

          -  Aspartate aminotransferase (AST) or alanine transaminase (ALT) ≦2.5 times the upper
             limit of normal (ULN) or ≦5 times the ULN if liver involvement with lymphoma.

          -  Life expectancy of at least 3 months.

          -  >4 weeks since last cycle of chemotherapy.

          -  Patient has recovered from all acute toxic effects of prior chemotherapy.

          -  Signed informed consent.

        Exclusion Criteria (abbreviated list):

          -  A second active malignancy (other than basal cell carcinoma of the skin).

          -  Uncontrolled central nervous system involvement by lymphoma.

          -  Positive/history of retroviral infection (HIV, HTLV-1).

          -  Active infection requiring antibiotics during planned lymphoma-related therapy.

          -  Previous treatment with high-dose chemotherapy or cytokine mobilization and
             hematopoietic progenitor cell transplantation.

          -  Continued evidence by morphology and flow cytometry of bone marrow involvement after
             at least one cycle of salvage chemotherapy.

          -  ≥3 cycles of salvage chemotherapy following documentation of lymphoma relapse or
             disease progression.

          -  (In patients with CD20(+) lymphoma) History of severe hypersensitivity reactions to
             rituximab.

          -  Positive pregnancy test in female patients.

          -  Lactating female patients.

          -  Previously received experimental therapy within 4 weeks of enrolling in this protocol
             or currently enrolled in another experimental protocol during G-CSF Mobilization
             Phase.

          -  Creatinine >1.5 times the ULN.

          -  Bilirubin >1.5 times the ULN.

          -  Ejection fraction <45%.

          -  Diffusion capacity of the lung for carbon monoxide (DLCO) <50%.

          -  Patients of childbearing potential unwilling to implement adequate birth control.

          -  A co-morbid condition that renders the patient at high risk from treatment
             complications.

          -  Residual acute medical condition resulting from prior chemotherapy.

          -  Documented history of ventricular arrhythmias during the last 3 years.

          -  Fever (temperature >38 °C/100.4 °F).

          -  Actual body weight exceeds 175% of ideal body weight.

          -  Participants who have deterioration of their clinical status or laboratory parameters
             between the time of enrolment and transplant (such that they no longer meet entry
             criteria) may be removed from study at the discretion of the treating physician,
             principal investigator, or sponsor.