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CompletedNCT01700608Updated Oct 4, 2012

Prospective Observational Study on Plerixafor After Chemotherapy

An observational study in Lymphoma and Myeloma, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-04.

Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
27
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Lymphoma
  • Myeloma
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In context

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF

Inclusion criteria

  • lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy and G-CSF

Exclusion criteria

Exclusion Criteria:

  • patients treated only with G-CSF and plerixafor without chemotherapy
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
27 participants (actual)

Groups and cohorts

  • plerixafor treated patients

    lymphoma and myeloma patients

    Drug: plerixafor

Interventions

  • Drugplerixafor

    plerixafor 240 mcg/kg/day at the hematopoietic recovery after chemotherapy

    Also known as: Mozobil

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What researchers measure

Primary outcomes

  1. Number of patients who were able to collect >= 2 x 10^6 CD34+/kg

    Time frame: 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.

    Time frame: 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

    Time frame: From day 1 to day 25 after mobilizing chemotherapy

07

Study locations

1 site
  • Fondazione IRCCS Istituto Nazionale dei Tumori
    Milan, 20133, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01700608
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Responsible party
Paolo Corradini (Professor, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano) — Principal investigator
First posted
Oct 4, 2012
Start date
Sep 2008
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Oct 4, 2012

Study contacts

Paolo Corradini, MD
principal investigator · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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