NCT00291811

Access Program for Use of AMD3100 to Increase Peripheral Blood Stem Cells for Transplantation in Patients Who Have Failed Standard Therapy Stem Cell Mobilization

Compassionate Use Protocol for the Use of AMD3100 to Mobilize Peripheral Blood Stem Cells for Collection and Transplantation

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this program is to provide access to AMD3100 for patients who would benefit from an autologous stem cell transplant but who have either previously failed to collect enough cells for transplant following standard therapy or are not considered by their physician to have a reasonable chance of collecting enough cells for transplant.

Detailed description

The purpose of this program is to provide access to AMD3100 for patients who would benefit from an autologous stem cell transplant but who have either previously failed to collect enough cells for transplant following standard therapy or are not considered by their physician to have a reasonable chance of collecting enough cells for transplant. Compassionate use is a way to provide experimental treatment to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Peripheral blood stem cells are obtained by apheresis following a stem cell mobilization regimen. The standard of care regimen for stem cell mobilization includes a growth factor, G-CSF. AMD3100 is given in addition to G-CSF prior to each apheresis session. If enough peripheral blood stem cells for transplant are collected, the patient is treated with high dose chemotherapy in preparation for transplant and is transplanted with cells obtained from the AMD3100 and G-CSF regimen. Patients are followed for safety and transplant outcomes for up to 12 months after transplant.

Conditions

• Autologous Stem Cell Transplant

Interventions

Type	Name	Description
DRUG	AMD3100 + G-CSF	Subcutaneous injection of 240 mcg/kg on the evening prior to each apheresis session

Timeline

• Start date: 2003-10-01
• First posted: 2006-02-15
• Last updated: 2014-02-11