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

Pr Mohamad MOHTY

Status: Completed

Conditions: Lymphoma

Treatments: Other: Time/Motion evaluation of actual apheresis

Study type: Observational

Funder types: Other

Identifiers

NCT02287012

Mozo Time and Motion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

248 participants in 2 patient groups

Pre-Plerixafor era

Description:

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

Description:

The second era (Plerixafor era) will be defined as July 1, 2010 through July 1, 2012).

Treatment:

Other: Time/Motion evaluation of actual apheresis