Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection -The European Perspective

Study Overview
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Brief Summary
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This study aims to observe the effects of the availability of plerixafor on the time and effort associated with autologous peripheral blood stem cell collection.

Detailed Description
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This non interventional study will consist of two parts: I. Retrospective study: A medical record review will be conducted covering 200 patients file undergoing peripheral blood stem cell mobilization in some European centers. II. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.

Official Title
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Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection - The European Perspective

Conditions
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Lymphoma

Intervention / Treatment
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* Other: Time/Motion evaluation of actual apheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must satisfy the following for the part 1 Oncology patients diagnosed with Non-Hodgkin lymphoma who are candidates for autologous hematopoietic stem cell transplantation (HSCT) A patient that fails to achieve a target CD34+>20 cells/µl, before or on the first day of apheresis Age > 18 years Exclusion Criteria for the part 1 Patients with: Age < 18 years; Primary diagnosis other than Non-Hodgkin lymphoma Undergone prior autologous hematopoietic stem cell transplantation (HSCT)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Plerixafor era<br>The first era (Pre-Plerixafor era) will be defined as a two year period immediately preceding commercialization of plerixafor in Europe, (e.g., June 1, 2007 through June 1, 2009). | |
| Plerixafor era<br>The second era (Plerixafor era) will be defined as July 1, 2010 through July 1, 2012). | Other: Time/Motion evaluation of actual apheresis<br>* The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, duration and length of administration of mobilizing agents | Number of visits for administration of mobilizing agents Duration (days) of administration of mobilizing agents Type of agents used as mobilizing agents | one week | 
| Number and length of apheresis sessions and number of collected stem cells | Number of apheresis sessions Number of hours of apheresis sessions Attainment of CD34+ cells target (yes, no) Number of days until CD34+ target level is met | one week |