A Pilot Cohort Study of AMD3100 in Combination With G-CSF and Rituximab Compared With AMD3100 in Combination With G-CSF Alone for Mobilization of BPCs in Patients With Relapsed or Refractory NHL or HD Prior to Autologous HPC Transplant
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
(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
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Day 1 and up to Day 59 (maximum time before start of chemotherapy)
United States: Food and Drug Administration
|Winship Cancer Institute||Atlanta, Georgia 30322|