Prospective Observational Study on Plerixafor After Chemotherapy
Information source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma; Myeloma
Intervention: plerixafor (Drug)
Phase: N/A
Status: Completed
Sponsored by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Official(s) and/or principal investigator(s): Paolo Corradini, MD, Principal Investigator, Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori
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.
Clinical Details
Official title: Prospective Observational Study on Plerixafor After Chemotherapy
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of patients who were able to collect >= 2 x 10^6 CD34+/kg
Secondary outcome: Number of patients who were able to collect > 4 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery
after chemotherapy and G-CSF
Exclusion Criteria:
- patients treated only with G-CSF and plerixafor without chemotherapy
Locations and Contacts
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan 20133, Italy
Additional Information
Starting date: September 2008
Last updated: October 2, 2012
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