Clinical trial NCT01700608: Prospective Observational Study on Plerixafor After Chemotherapy
Official title: Prospective Observational Study on Plerixafor After Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Myeloma
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF

Brief 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.

Eligibility 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

Primary outcomes:
measure: Number of patients who were able to collect >= 2 x 10^6 CD34+/kg
timeFrame: From day 1 to day 25 after mobilizing chemotherapy
Secondary outcomes:
measure: Number of patients who were able to collect > 4 x 10^6 CD34+/kg.
timeFrame: From day 1 to day 25 after mobilizing chemotherapy
Other outcomes:
measure: To determine the median number of apheresis to reach >= 2-4 x 10^6 CD34+/kg
timeFrame: From day 1 to day 25 after mobilizing chemotherapy
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Paolo Corradini, MD
role: PRINCIPAL_INVESTIGATOR
References: