LymphomaNCT02287012
Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection -The European Perspective
An observational study of Lymphoma, run by Pr Mohamad MOHTY.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Time/Motion evaluation of actual apheresis
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with:
- Age < 18 years;
- Primary diagnosis other than Non-Hodgkin lymphoma
- Undergone prior autologous hematopoietic stem cell transplantation (HSCT)
About this study
Official title: 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.
Read the detailed description
This non interventional study will consist of two parts:
- 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.
- Conditions
- Lymphoma
- Being tested
- Time/Motion evaluation of actual apheresis
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time/Motion evaluation of actual apheresisOther
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Time/Motion evaluation of actual apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr Mohamad MOHTY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr Mohamad MOHTY, Association for Training, Education, and Research in Hematology, Immunology, and Transplantation
- Investigators
- Mohamad Mohty, MD, PhD, Principal investigator, Hôpital Saint-Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287012
- Sponsor's protocol ID
- Mozo Time and Motion
- Status last verified
- Jan 2016
- First submitted
- 3 Nov 2014
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Time and Effort Required for Peripheral Blood Stem Cell Collection - The European Perspective
- ClinicalTrials.gov ID
- NCT02287012
- Acronym / sponsor ID
- Mozo Time and Motion
- Conditions
- Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Pr Mohamad MOHTYUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This non interventional study will consist of two parts:
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Time/Motion evaluation of actual apheresisThe second era (Plerixafor era) will be defined as July 1, 2010 through July 1, 2012). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Age < 18 years;
- Primary diagnosis other than Non-Hodgkin lymphoma
- Undergone prior autologous hematopoietic stem cell transplantation (HSCT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time/Motion evaluation of actual apheresisThe 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. | Other | Plerixafor era |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamad Mohty, MD, PhD principal investigator
Hôpital Saint-Antoine
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Pr Mohamad MOHTY.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, duration and length of administration of mobilizing agents (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.