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|
- Number of Participants Who Achieved > 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 ]
- Number of Participants Experiencing a Grade III/IV Toxicity [ Time Frame: 6 months post transplant or until relapse ] [ Designated as safety issue: Yes ]Safety of plerixafor as measured by Grade III/IV Toxicity
- Number of Subjects Experiencing Graft Failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]To investigate the hematological activity of Plerixafor as measured by Graft Failure. Graft failure is defined as failure of initial engraftment (primary graft failure) or initial engraftment, but subsequent loss of hematopoiesis (secondary graft failure).
- Days to Absolute Neutrophil Count >500 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Number of Subjects Experiencing Durability of Engraftment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Durability of engraftment is defined as the duration and stability of hematopoiesis following autologous transplantation. Subjects who experience durable engraftment have neutrophil counts greater than 500 and platelet counts greater than 20,000 within the specified time frame.
- Platelet Engraftment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Days to platelet count >20,000
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901225
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Mitchell Horwitz, MD||Duke University|