A Phase 2, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Poor Mobilizing Adult Patients Who Have Previously Failed Stem Cell Collection/Attempts
This is a Phase 2, multicenter, prospective, open-label study. Once 70 patients have
enrolled, subsequent patients enrolled should have a diagnosis of lymphoma. Patients who
would benefit from an autologous stem cell transplant, who have failed previous collections
or collection attempts with a mobilization regimen of granulocyte colony-stimulating factor
(G-CSF) alone, chemotherapy and G-CSF, or any other conventional therapy including
cytokines, chemotherapy and cytokines and bone marrow harvests, and who meet the
inclusion/exclusion criteria are eligible to receive plerixafor as outlined in this
protocol. The only change to standard of care of a mobilization regimen that includes G-CSF
is the addition of a dose of plerixafor on the evening prior to each day of apheresis.
Patients will undergo mobilization with G-CSF (10 µg/kg) for 4 days. On Day 4, plerixafor
(240 µg/kg) will be administered in the evening prior to the first apheresis and each
subsequent evening prior to apheresis thereafter, such that there is a 10 to 11 hour
interval between dosing and the initiation of apheresis. Patients will continue to receive
G-CSF on each day of apheresis. Patients will undergo a minimum of 2 and a maximum of 7
aphereses or until ≥2*10^6 CD34+ cells/kg are collected, whichever occurs first. In
addition, the mobilization of NHL tumor cells and the pharmacokinetics of repeat doses of
plerixafor will be examined.
After the last apheresis has been completed, or after the patient has collected ≥2*10^6
CD34+ cells/kg, he/she will be treated with high-dose chemotherapy in preparation for
transplantation. Patients will be transplanted with cells obtained from the G-CSF with
plerixafor mobilization regimen. In the event that the minimum number of ≥2*10^6 cells for
transplantation are not obtained from the first mobilization with plerixafor, cells may be
retained and pooled for transplantation with those from a second mobilization with
plerixafor (or from prior mobilization with other agents), at the investigator's discretion.
If a second mobilization with plerixafor is attempted, a minimum rest interval of one week
should be allowed between the last apheresis of the first regimen and the first dose of
G-CSF of the second. The number of CD34+ cells mobilized in the peripheral blood (PB),
collected in the apheresis product, and the number of apheresis sessions performed will be
measured. Success of the transplantation will be evaluated by the time to engraftment of
polymorphonuclear leukocytes (PMN) and platelets (PLT). Participants will be assessed for
durability of their transplant for 12 months after 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment Period
Number of participants with adverse events (AEs) collected from Day 1 (start of G-CSF mobilization) 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 severity (mild, moderate, severe, life-threatening) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Day 1 to approximately day 38
United States: Food and Drug Administration
|Hackensack University Medical Center||Hackensack, New Jersey 07601|
|H. Lee Moffitt Cancer Center||Tampa, Florida 33612|
|Kansas City Cancer Centers||Kansas City, Missouri 64111|
|City of Hope National Medical Center`||Duarte, California 91010|
|Blood & Marrow Transplant Group of Georgia||Atlanta, Georgia 30342|
|University of Mississippi Medical Center, Div of Hematology||Jackson, Mississippi 39216|
|Virginia Commonwealth University - Massey Cancer Center||Richmond, Virginia 23298-0037|
|University of Wisconsin, Blood and Bone Marrow Transplant||Madison, Wisconsin 53792-5156|