Prospective Observational Study on Plerixafor After Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paolo Corradini, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01700608
First received: October 1, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Lymphoma
Myeloma
Drug: plerixafor

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Observational Study on Plerixafor After Chemotherapy

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: September 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
plerixafor treated patients
lymphoma and myeloma patients
Drug: plerixafor
plerixafor 240 mcg/kg/day at the hematopoietic recovery after chemotherapy
Other Name: Mozobil

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700608

Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
Principal Investigator: Paolo Corradini, MD Fondazione IRCCS Istituto Nazionale dei Tumori
  More Information

No publications provided

Responsible Party: Paolo Corradini, Professor, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01700608     History of Changes
Other Study ID Numbers: 011012
Study First Received: October 1, 2012
Last Updated: October 2, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
JM 3100
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 08, 2014