Prospective Observational Study on Plerixafor After Chemotherapy
1 other identifier
observational
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedOctober 4, 2012
October 1, 2012
3.6 years
October 1, 2012
October 2, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients who were able to collect >= 2 x 10^6 CD34+/kg
From day 1 to day 25 after mobilizing chemotherapy
Secondary Outcomes (1)
Number of patients who were able to collect > 4 x 10^6 CD34+/kg.
From day 1 to day 25 after mobilizing chemotherapy
Other Outcomes (1)
To determine the median number of apheresis to reach >= 2-4 x 10^6 CD34+/kg
From day 1 to day 25 after mobilizing chemotherapy
Study Arms (1)
plerixafor treated patients
lymphoma and myeloma patients
Interventions
plerixafor 240 mcg/kg/day at the hematopoietic recovery after chemotherapy
Eligibility Criteria
lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF
You may qualify if:
- lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF
You may not qualify if:
- patients treated only with G-CSF and plerixafor without chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Corradini, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 4, 2012
Study Start
September 1, 2008
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
October 4, 2012
Record last verified: 2012-10