Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
| Status: | Archived |
|---|---|
| Conditions: | Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2009 |
| End Date: | April 2013 |
An Observational Study of Plerixafor Mobilization Rescue for Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF
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.
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. At total of 20
patients will be enrolled. Enrollment will be stratified such that a total of 10 subjects
will carry the diagnosis of multiple myeloma and have received prior lenalidomide therapy.
The other 10 patients will carry the diagnosis of non-hodgkins lymphoma, hodgkins disease or
multiple myeloma and not have prior therapy with lenalidomide.
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.
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