Clinical Trials Directory

Trials / Completed

CompletedNCT01700608

Prospective Observational Study on Plerixafor After Chemotherapy

Status
Completed
Phase
Study type
Observational
Enrollment
27 (actual)
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC) mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be more efficient and cost-effective, but the timing of administration and criteria for patient selection are still under investigation. We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF. The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt, according to the attending physician choice. The primary endpoint was the assessment of the rate of patients who were able to collect \>=2 x 10\^6 CD34+/kg.

Detailed description

Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell (PBSC) mobilization when combined with granulocyte-colony-stimulating factor (G-CSF). The 'on demand' use of plerixafor at the hematopoietic recovery after chemotherapy + G-CSF may be more efficient and cost-effective, but the timing of administration and criteria for patient selection are still under investigation. We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy + G-CSF. The decision of adding plerixafor was based on PB CD34+ cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt, according to the attending physician choice. The primary endpoint was the assessment of the rate of patients who were able to collect \>=2 x 10\^6 CD34+/kg. Secondary endpoint was the assessment of the rate of patients collecting \> 4 x 10\^6 CD34+/kg and the median number of apheresis to reach the target.

Conditions

Interventions

TypeNameDescription
DRUGplerixaforplerixafor 240 mcg/kg/day at the hematopoietic recovery after chemotherapy

Timeline

Start date
2008-09-01
Primary completion
2012-04-01
Completion
2012-04-01
First posted
2012-10-04
Last updated
2012-10-04

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01700608. Inclusion in this directory is not an endorsement.