Blood Stem Cell Harvest FailurePhase 2MOBIL1NCT01954914
Plerixafor as a Salvage Regimen to Mobilize Allogeneic Stem Cells in Healthy Volunteers
A Phase 2 study testing Plerixafor in people with Blood Stem Cell Harvest Failure, run by Technische Universität Dresden at 3 sites in Germany.
Trial summary
With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are therefore called "poor mobilizers". Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Stem Cell Harvest Failure
- What is being tested?
- Plerixafor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesGermany
- Study dates
- Dec 2013to Jan 2016
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Donor age between 18 years and 75 years
- Eligibility of the donor for allogeneic PBSC donation according to German Guidelines (Richtlinien Hämotherapie Bundesärztekammer 2005) preceding the application of G-CSF
- The donor has understood and signed the donor information. Written informed consent has been obtained.
- Donation of less than 2.0 x 106 CD34 cells/kg recipient body weight after one apheresis following five days of stem-cell mobilization with Lenograstim 7.5 to 10 µg/kg donor body weight
- First leukapheresis according to standard recommendations with a processing of 3 x donor's blood volume ± 10% using either of the following three devices: Cobe Spectra (Terumo BCT) Spectra Optia (Terumo BCT) Fresenius COM.TEC
Who cannot join
- Pain or any discomfort in the left upper square of the abdomen during physical examination immediately prior to study inclusion or any spontaneous complaint about abdominal discomfort without an ultrasound investigation which rules out splenomegaly.
- Palpitations or any thoracic discomfort in the absence of an ECG which shows normal results
- Platelet count < 80 x 109/l
- Serum creatinine > 80 µmol/l for female donors or > 106 µmol/l for male donors. If serum creatinine is elevated then the estimated creatinine clearance has to be > 50 ml/min. Estimation by the Modification of Diet in Renal Disease equation where predicted GFR(ml/min/1.73m2) = 186 x (Serum Creatinine in mg/dL)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black) or GFR(ml/min/1.73m2) = 186 x 176 (Serum Creatinine in µmol/l)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
- Contraindications against a second leukapheresis, such as severe side effects during 1st leukapheresis (intolerable pain, severe circulatory disorder, severe citrate intolerance)
- Missing written approval by the transplant center that the transplantation of the Plerixafor-mobilized graft is being considered
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- Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrolment or participation in any other interventional clinical study
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise donor safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
- Female donors of childbearing potential unable or unwilling to use adequate contraception methods for three months after the administration of the study drug. Adequate methods for contraception in female donors are sexual abstinence, the use of condoms by their partners, vasectomy of the partner or hormonal contraception.
- Male donors unable or unwilling to use adequate contraception methods for one month after the administration of the study drug. Adequate methods for contraception for males are sexual abstinence or the use of condoms.
- Known intolerance to Plerixafor
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Cellex Gesellschaft für Zellgewinnung mbH Köln
Cologne, 50670
Cellex Gesellschaft für Zellgewinnung mbH Dresden
Dresden, 01307
Universitätsklinikum Dresden, Medizinische Klinik I
Dresden, 01307
About this study
With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are therefore called "poor mobilizers". A generally accepted optimum CD34+ PBSC dose for allogeneic transplantation is > 4.5 x 106/kg body weight of the recipient. The minimum total CD34+ PBSC dose certainly amounts to 2 x 106/kg body weight of the recipient.The objective of this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure in allogeneic stem cell donors with a poor CD34+ cell yield after the first day of peripheral blood stem cell collection.
Read the detailed description
In this trial the administration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1 will be provided. The apheresis on day 2 is performed according to standard recommendations.
- Conditions
- Blood Stem Cell Harvest Failure
- Being tested
- Plerixafor
- Keywords
- Plerixafor, donor, allogeneic peripheral stam cell donation, PBSC, poor donors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlerixaforDrug
Also called Mozobil
Administration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1.
| Study group | Role | What they receive |
|---|---|---|
| Plerixafor, Mozobil | Experimental | Administration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1. Receives: Drug: Plerixafor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of donation success
A generally accepted optimum CD34+ PBSC dose for allogeneic transplantation is > 4.5 x 10e6/kg body weight of the recipient. The minimum total CD34+ PBSC dose certainly amounts to 2 x 10e6/kg body weight of the recipient.
Measured: 1 day
Secondary outcomes (1)
Assessment of donor safety and tolerability based on self-reporting on a questionnaire, clinical findings, and laboratory evaluations; and evaluation of the cellular composition of the apheresis products collected with and without Plerixafor application.
The composition of apheresis products collected after filgrastim or filgrastim plus Plerixafor will be characterized with respect to:
- CD34+ cell subsets (differential expression of prominin1/CD133+)33
- Regulatory T-cells34
- Dendritic cells
- Myeloid-derived suppressor cells
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stem Cell Harvest FailureStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Carl Gustav Carus, Cellex Gesellschaft für Zellgewinnung mbH Dresden, Cellex Gesellschaft für Zellgewinnung mbH Köln
- Responsible party
- Sponsor
- Investigators
- Kristina Hölig, Dr. med., Principal investigator, Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954914
- Sponsor's protocol ID
- TUD-MOBIL1-056
- Acronym
- MOBIL1
- Status last verified
- Sep 2016
- First submitted
- 27 Sep 2013
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plerixafor as a Salvage Regimen to Mobilize Allogeneic Stem Cells in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01954914
- Acronym / sponsor ID
- MOBIL1 / TUD-MOBIL1-056
- Conditions
- Blood Stem Cell Harvest Failure
- Keywords
- Plerixafor, donor, allogeneic peripheral stam cell donation, PBSC, poor donors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- University Hospital Carl Gustav Carus, Cellex Gesellschaft für Zellgewinnung mbH Dresden, Cellex Gesellschaft für Zellgewinnung mbH Köln
- Study start
- Dec 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Oct 2013 (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.
With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are therefore called "poor mobilizers". A generally accepted optimum CD34+ PBSC dose for allogeneic transplantation is > 4.5 x 106/kg body weight of the recipient. The minimum total CD34+ PBSC dose certainly amounts to 2 x 106/kg body weight of the recipient.The objective of this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure in allogeneic stem cell donors with a poor CD34+ cell yield after the first day of peripheral blood stem cell collection.
Detailed description
In this trial the administration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1 will be provided. The apheresis on day 2 is performed according to standard recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plerixafor, Mozobil | Experimental | Drug: PlerixaforAdministration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Donor age between 18 years and 75 years
- Eligibility of the donor for allogeneic PBSC donation according to German Guidelines (Richtlinien Hämotherapie Bundesärztekammer 2005) preceding the application of G-CSF
- The donor has understood and signed the donor information. Written informed consent has been obtained.
- Donation of less than 2.0 x 106 CD34 cells/kg recipient body weight after one apheresis following five days of stem-cell mobilization with Lenograstim 7.5 to 10 µg/kg donor body weight
- First leukapheresis according to standard recommendations with a processing of 3 x donor's blood volume ± 10% using either of the following three devices: Cobe Spectra (Terumo BCT) Spectra Optia (Terumo BCT) Fresenius COM.TEC
Key exclusion criteria (11 listed)
- Pain or any discomfort in the left upper square of the abdomen during physical examination immediately prior to study inclusion or any spontaneous complaint about abdominal discomfort without an ultrasound investigation which rules out splenomegaly.
- Palpitations or any thoracic discomfort in the absence of an ECG which shows normal results
- Platelet count < 80 x 109/l
- Serum creatinine > 80 µmol/l for female donors or > 106 µmol/l for male donors. If serum creatinine is elevated then the estimated creatinine clearance has to be > 50 ml/min. Estimation by the Modification of Diet in Renal Disease equation where predicted GFR(ml/min/1.73m2) = 186 x (Serum Creatinine in mg/dL)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black) or GFR(ml/min/1.73m2) = 186 x 176 (Serum Creatinine in µmol/l)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
- Contraindications against a second leukapheresis, such as severe side effects during 1st leukapheresis (intolerable pain, severe circulatory disorder, severe citrate intolerance)
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: MozobilAdministration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1. | Drug | Plerixafor, Mozobil |
Primary outcome
Rate of donation success
Time frame: 1 day
A generally accepted optimum CD34+ PBSC dose for allogeneic transplantation is > 4.5 x 10e6/kg body weight of the recipient. The minimum total CD34+ PBSC dose certainly amounts to 2 x 10e6/kg body weight of the recipient.
1 secondary outcome
Assessment of donor safety and tolerability based on self-reporting on a questionnaire, clinical findings, and laboratory evaluations; and evaluation of the cellular composition of the apheresis products collected with and without Plerixafor application.
Time frame: 30 days
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 19 Sep 2016.
- Individual participant dataSharing planned: No
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.
Kristina Hölig, Dr. med. principal investigator
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
3 sites 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 in people with Blood Stem Cell Harvest Failure, run by Technische Universität Dresden at 3 sites in Germany.
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 5 inclusion and 11 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 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 donation success (time frame: 1 day). 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 19 Sep 2016.