A Phase I/II Study of Intravenous AMD3100 Added to a Mobilization Regimen of G-CSF to Increase the Number of Autologous Peripheral Blood Stem Cells Collected From Patients With Lymphoma
Autologous stem cell transplantation (ASCT) is indicated for patients with non-Hodgkin
lymphoma (NHL) or Hodgkin lymphoma (HL) who have primary progressive disease or who relapse
after a chemotherapy-induced complete remission. For these patients, as for other patients
undergoing autologous transplantation, the number of CD34+ cells collected is a reliable
predictor of neutrophil and platelet (PLT) engraftment after transplantation.
AMD3100 (plerixafor) is a promising new mobilizing agent that has demonstrated efficacy in
patients with NHL, HL, and multiple myeloma (MM). Although efficacious, the subcutaneous
dosing of AMD3100 requires that patients receive the drug in the evening prior to apheresis,
which can present logistical problems. Intravenous dosing of AMD3100 may result in a faster
rise in peripheral CD34+ cell count, so that the drug can be administered the same day as
apheresis. Intravenous dosing may also increase the peak CD34+ cell count, improving the
number of CD34+ cells collected via apheresis.
This Phase I/II study will evaluate the safety and efficacy of intravenous AMD3100 added to
the standard G-CSF mobilization regimen of patients undergoing autologous stem cell
transplantation for Hodgkin and non-Hodgkin lymphomas.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of IV AMD3100 + G-CSF in mobilization of peripheral blood stem cell in patients with lymphoma
7 days from first dose of IV AMD3100
Amanda F. Cashen, M.D.
United States: Food and Drug Administration
08-0897 / 201105349
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