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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

Page last updated: August 23, 2015

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