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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02287012

Enrollment

248

Registered

2014-11-10

Start date

2013-10-31

Completion date

2015-10-31

Last updated

2016-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Brief summary

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

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.

Interventions

OTHERTime/Motion evaluation of actual apheresis

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Type, duration and length of administration of mobilizing agents	one week	Number of visits for administration of mobilizing agents Duration (days) of administration of mobilizing agents Type of agents used as mobilizing agents
Number and length of apheresis sessions and number of collected stem cells	one week	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026