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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma
• Intervention / Treatment: Other: Time/Motion evaluation of actual apheresis

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.

• Study Type: Observational
• Enrollment (Actual): 248

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The 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 different European centers. Patients will be selected from each of centers, evenly divided between two eras: 1) prior to approval of plerixafor= Pre-P era (July 2009); and 2) after approval of plerixafor= P era .

II. Prospective study :Time/Motion evaluation of actual apheresis - 20 events each center

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-Plerixafor era; 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; The second era (Plerixafor era) will be defined as July 1, 2010 through July 1, 2012).	Other: Time/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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pr Mohamad MOHTY
• Investigators: Principal Investigator: Mohamad Mohty, MD, PhD, Hopital Saint-Antoine

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 10, 2014

Study Record Updates

• Last Update Posted (Estimate): October 7, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Mozo Time and Motion