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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Winship Cancer Institute
Atlanta, Georgia, United States
Summary of Adverse Events (AEs)
Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization in participants with CD20- lymphoma or start of rituximab in participants with CD20+ lymphoma) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for seriousness and relatedness to study treatment.
Time frame: Day 1 and up to Day 59 (maximum time before start of chemotherapy)
Median Cumulative Number of CD34+ Cells Collected During Apheresis
Median total number of CD34+ cells collected during apheresis.
Time frame: Days 5-8
Median Fold Increase in the Number of CD34+ Cells After Plerixafor Administration
Fold Increase = (Pre-Apheresis CD34+ cells/Pre-Plerixafor CD34+ cells).
Time frame: Days 4-5
Median Number of Apheresis Days Required to Reach a Minimum of 3*10^6 CD34+ Cells/kg
Median number of apheresis days in each treatment arm to collect a minimum of 3\*10\^6 CD34+ cells/kg.
Time frame: Days 5-8
Median Number of Apheresis Days Required to Reach the Target of 5*10^6 CD34+ Cells/kg
Median number of apheresis days in each treatment arm to reach the target of 5\*10\^6 CD34+ cells/kg.
Time frame: Days 5-8
Median Number of Days to Polymorphonuclear Leukocyte (PMN) Engraftment
Median number of days from transplantation to PMN engraftment which was defined as PMN counts ≥0.5\*10\^9/L for 3 consecutive days or ≥1.0\*10\^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
Time frame: Days post transplantation (approximately Day 40)
Median Number of Days to Platelet (PLT) Engraftment
Median number of days from transplantation to PLT engraftment which was defined as platelet counts ≥20\*10\^9/L without transfusion for the preceding 7 days or platelet counts ≥50\*10\^9/L for one day. Time to engraftment corresponded to the first day that the criteria were met.
Time frame: Days post transplantation (approximately Day 40)
Median Number of Days to Lymphocyte Engraftment
Median number of days from transplantation to lymphocyte engraftment which was defined as lymphocyte counts ≥5\*10\^8/L. Time to engraftment corresponded to the first day that criteria were met.
Time frame: Days post transplantation (approximately Day 40)
Median Level of CD19+CD2-CD14- B-cells Six Months Post-Transplant
Time frame: Approximately 7 months (6 months post-transplant)
Median Level of CD19+CD2-CD14- B-cells Twelve Months Post-Transplant
Time frame: 13 months (12 months post-transplant)
The Percentage of CD19+CD3-CD14- B-cells of the Total Cells on the First Apheresis Day
Time frame: Day 5
Number of Participants With Durable Engraftment 12 Months After Transplantation
The number of participants maintaining a durable graft 12 months after autologous transplantation. A durable graft is defined as the maintenance of normal blood counts.
Time frame: Approximately 13 months (12 months post-transplant )
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