Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008, Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor. The route of administration and dosage level are identical to that which is listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins Lymphoma, there is no known or theoretic increased risk of the use of this drug in this patient population.
The study hypothesis for this study is that patients with a circulating CD34+ count < 20 cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
Drug: G-CSF plus Plerixafor
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Plerixafor Rescue Mobilization For Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF|
- To assess, among patients with < 20 CD34+ cells/ul after 5 days of mobilization with G-CSF alone, the percentage who achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF. [ Time Frame: 5 days after receiving G-CSF ] [ Designated as safety issue: No ]
- To evaluate if Plerixafor is generally safe. [ Time Frame: 6 months post transplant or until relapse ] [ Designated as safety issue: Yes ]
- To investigate the hematological activity of Plerixafor. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To determine the times of neutrophil and platelet engraftment. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To determine the durability of engraftment. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||May 2013|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: G-CSF plus Plerixafor
Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
Drug: G-CSF plus Plerixafor
On Day 5 of G-CSF mobilization,
Other Name: Mozobil, AMD3100
This is a single-center, Phase 2, open-label study. All patients diagnosed with non-hodgkins lymphoma, hodgkins disease or multiple myeloma and candidates for autologous transplantation are eligible to enter into the study. The only change to the standard of care is the addition of 240 ug/kg Plerixafor following 5 days of (G-CSF) mobilization.
The results of the study will provide both numeric and categorical estimates of measurements of the safety and efficacy of Plerixafor. The primary efficacy endpoint, Treatment Success, is a binary response variable categorizing whether the patient was able to mobilize at least 2 X 10(6) CD34+ cells/kg within 3 days of apheresis.
The percentage of patients achieving Treatment Success will be summarized. All AEs will be followed for 30 days after the last apheresis or until the first dose of ablative chemotherapy, whichever occurs first. All SAEs will be followed for 6 months post-transplant or until relapse. All patients who receive at least one dose of Plerixafor will be included in all summaries of AEs.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Mitchell Horwitz, MD||Duke University|