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

October 6, 2016 updated by: Pr Mohamad MOHTY

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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
one week
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
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pr Mohamad MOHTY

Investigators

  • Principal Investigator: Mohamad Mohty, MD, PhD, Hôpital Saint-Antoine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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