Prospective Observational Study on Plerixafor After Chemotherapy

Lymphoma Clinical Trial

Official title:

Prospective Observational Study on Plerixafor After Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700608
• Other study ID #: 011012
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: October 2, 2012
• Start date: September 2008
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma
• Myeloma

Intervention

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

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Number of patients who were able to collect >= 2 x 10^6 CD34+/kg		From day 1 to day 25 after mobilizing chemotherapy	No
Secondary	Number of patients who were able to collect > 4 x 10^6 CD34+/kg.		From day 1 to day 25 after mobilizing chemotherapy	No