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

NCT02287012 | Completed

• 1 other identifier: Mozo Time and Motion
• Study Type: observational
• Target: 248
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Interventions

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.

Plerixafor era

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients with:
• Age \< 18 years;
• Primary diagnosis other than Non-Hodgkin lymphoma
• Undergone prior autologous hematopoietic stem cell transplantation (HSCT)

Sponsors & Collaborators

• Pr Mohamad MOHTY: lead

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mohamad Mohty, MD, PhD

  Hôpital Saint-Antoine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 10, 2014
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 7, 2016

Record last verified: 2016-01