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Prospective Observational Study on Plerixafor After Chemotherapy

NCT ID: NCT01700608

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Lymphoma Myeloma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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plerixafor treated patients

lymphoma and myeloma patients

plerixafor

Intervention Type DRUG

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

Interventions

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plerixafor

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

Intervention Type DRUG

Other Intervention Names

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Mozobil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role lead

Responsible Party

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Paolo Corradini

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo Corradini, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Locations

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Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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011012

Identifier Type: -

Identifier Source: org_study_id