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Completed

NCT Number: NCT02287012

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Time/Motion evaluation of actual apheresis

Other

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.

Primary outcomes

  1. Type, duration and length of administration of mobilizing agents

    Time frame: one week

    Number of visits for administration of mobilizing agents Duration (days) of administration of mobilizing agents Type of agents used as mobilizing agents

  2. Number and length of apheresis sessions and number of collected stem cells

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pr Mohamad MOHTY

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 10, 2014
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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