Prospective Observational Study on Plerixafor After Chemotherapy
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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 |
- 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 ]
- 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 ]
- 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 |
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:
- patients treated only with G-CSF and plerixafor without chemotherapy
Contacts and Locations| Italy | |
| Fondazione IRCCS Istituto Nazionale dei Tumori | |
| Milan, Italy, 20133 | |
| 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 June 18, 2013