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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287012
• Other study ID #: Mozo Time and Motion
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: October 6, 2016
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pr Mohamad MOHTY

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No