Non-Hodgkin's LymphomaPhase 2NCT01339572
Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation
A Phase 2 study testing Plerixafor and Filgrastim in people with Non-Hodgkin's Lymphoma and Multiple Myeloma, run by University of Florida at 1 site in United States.
Trial summary
This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Multiple Myeloma
- What is being tested?
- Plerixafor and Filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Nov 2015
- Phase
- Phase 2
- 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
Who may be able to join
- Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization.
- Karnofsky Performance Status ≥ 70.
- Age ≥ 18
- Less than 30% involvement of marrow with disease.
Who cannot join
- > 30% marrow involvement with disease
- Age < 18.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Cancer Hospital at the University of Florida
Gainesville, Florida, 32608
About this study
This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.
Read the detailed description
Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.
- Conditions
- Non-Hodgkin's Lymphoma, Multiple Myeloma
- Being tested
- Plerixafor, Filgrastim
- Keywords
- autologous transplantation, peripheral stem cell mobilization
- Medical subject headings
- Lymphoma, Non-Hodgkin, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called AMD3100
240 mcg/kg/day based on ideal body weight will be given for the following conditions:
- Pre-apheresis peripheral blood CD34+ count <20 cells/μL on day 5.
- Estimated CD34+ cell collection is < 25% of target cell dose after 1 day of apheresis.
- Estimated CD34+ cell collection is < 50% of target cell dose after 2 days of apheresis.
FilgrastimDrug
Also called G-CSF
All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient:
- Standard risk: 5 μg/kg SQ BID.
- High risk: 10 μg/kg SQ BID.
| Study group | Role | What they receive |
|---|---|---|
| Plerixafor | Experimental | All subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen. Receives: Drug: Plerixafor; Drug: Filgrastim |
| Observation | Active comparator | All subjects will receive filgrastim as part of their primary mobilization regimen. If the subject meets minimum peripheral blood CD34+ cell count levels or adequately collects a threshold number of CD34+ cells, plerixafor will not be added to the mobilization regimen. Receives: Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers
The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls.
Measured: Day 2 of apheresis
Secondary outcomes (3)
Economic impact
The economic impact of plerixafor use will be divided into two phases, mobilization and transplantation. The comparator arm for the mobilization phase would be matched historical controls. The comparator arm for the transplant phase will be patients who did not require plerixafor for mobilization during the study period.
Measured: Day 2 of mobilization and Day +100 after transplantation
Kinetics of CD34+ mobilization with early introduction of plerixafor
The kinetics of CD34+ cell counts during mobilization in this setting is unknown. We will attempt to determine mobilization kinetics by following peripheral blood CD34+ counts daily starting from first day of plerixafor administration until completion of apheresis. Kinetics will be analyzed according to the following parameters:
- Peripheral CD34 cell counts on each day of apheresis.
- Total CD34 cells collected on each day of apheresis
- Multiple myeloma vs. NHL.
Measured: On Day 1 and Day 2 of apheresis
Graft composition
Graft composition will be analyzed on each day of successful apheresis. Cell populations to be quantitated include total CD3+ lymphocytes, CD4+ lymphocytes, CD8+ lymphocytes.
Measured: On Day 1 and Day 2 of apheresis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack W Hsu, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339572
- Sponsor's protocol ID
- Plerixafor-UF01
- Status last verified
- Jul 2017
- First submitted
- 15 Apr 2011
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation
- ClinicalTrials.gov ID
- NCT01339572
- Acronym / sponsor ID
- Plerixafor-UF01
- Conditions
- Non-Hodgkin's Lymphoma, Multiple Myeloma
- Keywords
- autologous transplantation, peripheral stem cell mobilization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Apr 2011 (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 protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.
Detailed description
Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plerixafor | Experimental | Drug: Plerixafor, Drug: FilgrastimAll subjects will receive filgrastim as part of their primary mobilization regimen. If a subject does not meet minimum peripheral blood CD34+ cell count levels or fails to adequately collect a threshold number of CD34+ cells, plerixafor will be added to the mobilization regimen. |
| Observation | Active comparator | Drug: FilgrastimAll subjects will receive filgrastim as part of their primary mobilization regimen. If the subject meets minimum peripheral blood CD34+ cell count levels or adequately collects a threshold number of CD34+ cells, plerixafor will not be added to the mobilization regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization.
- Karnofsky Performance Status ≥ 70.
- Age ≥ 18
- Less than 30% involvement of marrow with disease.
Key exclusion criteria (3 listed)
- > 30% marrow involvement with disease
- Age < 18.
- Pregnant women.
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 |
|---|---|---|
| PlerixaforAlso: AMD3100240 mcg/kg/day based on ideal body weight will be given for the following conditions: 1. Pre-apheresis peripheral blood CD34+ count <20 cells/μL on day 5. 2. Estimated CD34+ cell collection is < 25% of target cell dose after 1 day of apheresis. 3. Estimated CD34+ cell collection is < 50% of target cell dose after 2 days of apheresis. | Drug | Plerixafor |
| FilgrastimAlso: G-CSFAll patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: * Standard risk: 5 μg/kg SQ BID. * High risk: 10 μg/kg SQ BID. | Drug | Observation, Plerixafor |
Primary outcome
Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers
Time frame: Day 2 of apheresis
The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls.
3 secondary outcomes
Economic impact
Time frame: Day 2 of mobilization and Day +100 after transplantation
Kinetics of CD34+ mobilization with early introduction of plerixafor
Time frame: On Day 1 and Day 2 of apheresis
Graft composition
Time frame: On Day 1 and Day 2 of apheresis
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 1 Aug 2017.
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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.
Jack W Hsu, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plerixafor and Filgrastim in people with Non-Hodgkin's Lymphoma and Multiple Myeloma, run by University of Florida at 1 site in United States.
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 3 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers (time frame: Day 2 of apheresis). 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 1 Aug 2017.