Children Cancer, Solid TumorPhase 2MEP1NCT01225419
Mobilization by Plerixafor of Haematopoietic Stem Cells in Children
A Phase 2 study testing Plerixafor, mozobil in people with Children Cancer, Solid Tumor, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This is a prospective Phase II, monocentre study. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Children Cancer, Solid Tumor
- What is being tested?
- Plerixafor, mozobil
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to May 2011
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 0 to 18 years old
- Solid malign tumor
- Lansky score ≥ 70%
- Indication of hematopoietic stem cell taking by cytapheresis for extensive chemotherapy followed by one or several reinjections of hematopoietic stem cells
Who cannot join
- Administration of hematopoietic growth factors in 8 days preceding the injection of Plerixafor.
- Contraindication in the cytapheresis or in the extensive chemotherapy.
- Clinical or biological state dissuading the realization of the cytapheresis
- Chemotherapy in 15 days preceding the injection of plerixafor or neutrophils < 1500/mm3
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective Phase II, monocentre study.
Read the detailed description
The extensive chemotherapy followed of hematopoietic stem cells reinjection (HSC) is one therapeutic option which the profit is well demonstrated in the treatment of children's solid tumors. It's one of the "standard" treatment of the following tumors: neuroblastoma, metastatic medulloblastoma, Ewing sarcoma, lymphoma in relapse; and because of the big chemosensibility of paediatric cancers, stays an important therapeutic option in the rhabdomyosarcoma in relapse or metastatic, nephroblastoma, etc. The stem cells can be taken in the blood by cytapheresis after mobilization with pharmacologic molecules. At present, the reference of the mobilization treatment is the G-CSF (Granulocyte colony-stimulating factor) in monotherapy during 4 to 6 days. His inconveniences are: lasted of the treatment (4 to 6 days), reproduction of the injections (1 to 2 subcutaneous injections daily), day variability of the peak of mobilization, this hematopoietic stimulation imposes to delay the chemotherapy. The plerixafor activates a massive and fast mobilization of the HSC ( hematopoietic stem cells)(between 6 and 11 hours after the injection). Currently, it's indicated in association with the G-CSF ( Granulocyte colony-stimulating factor)in case of mobilization failure. However, his big flexibility of use could be of a big interest in monotherapy at the child. To date, there is in our knowledge no data on the use of this molecule at the child.
Schema of study: Subcutaneous injection of 240 µg/kg of Plerixafor (Mozobil ®, Genzyme) at 8 am the day of the cytapheresis. Determination of CD34+ cells circulating in h0 then every hour of h3 to h11. Taking by cytapheresis from the 5th hour of the injection if the rate of CD34+ is upper or equal in 10.106/l. If the rate of CD34+ in the blood does not reach 10.106/l after the first injection of plerixafor or if the first cytapheresis does not allow the collection of at least 5.106/kg CD34+ cells, the patient will be considered in failure and a conventional mobilization by G-CSF(Granulocyte colony-stimulating factor) will be programmed.
- Conditions
- Children Cancer, Solid Tumor
- Being tested
- Plerixafor, mozobil
- Keywords
- Plerixafor, Hematopoietic Stem Cell Transplant mobilization, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plerixafor, mozobilDrug
Subcutaneous injection of 240 µg/kg of Plerixafor (Mozobil ®, Genzyme) at 8 am the day of the cytapheresis. Determination of CD34+ cells circulating in h0 then every hour of h3 to h11. Taking by cytapheresis from the 5th hour of the injection if the rate of CD34+ is upper or equal in 10.106/l. If the rate of CD34+ in the blood does not reach 10.106/l after the first injection of plerixafor or if the first cytapheresis does not allow the collection of at least 5.106/kg CD34+ cells, the patient will be considered in failure and a conventional mobilization by G-CSF will be programmed
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the children to whom 5.106 cells CD34 + / kg can be collected in 2 masses blood treated (one cytapheresis).
Measured: between H4 and H9 at day 0
Secondary outcomes (5)
Describe the kinetics of mobilization of the hematopoietic progenitor at the child in situation of hematopoietic stable state after a subcutaneous injection of plerixafor
Measured: between the injection and the apheresis at day 0
Describe the pharmacokinetics of the plerixafor at the child
Measured: between the injection and the apheresis at day 0
Describe the side effects
Measured: day 0 to day 3
Describe the capacity of hematopoietic reconstruction of taken cells after mobilization by plerixafor only
Measured: during the 30 following days
the toxicity of the plerixafor at the child.
Measured: day 0 to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Cancer, Solid TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne MERLIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225419
- Sponsor's protocol ID
- CHU-0082
- Acronym
- MEP1
- Status last verified
- Jul 2014
- First submitted
- 5 Oct 2010
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilization by Plerixafor of Haematopoietic Stem Cells in Children
- ClinicalTrials.gov ID
- NCT01225419
- Acronym / sponsor ID
- MEP1 / CHU-0082
- Conditions
- Children Cancer, Solid Tumor
- Keywords
- Plerixafor, Hematopoietic Stem Cell Transplant mobilization, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Oct 2010 (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 is a prospective Phase II, monocentre study.
Detailed description
The extensive chemotherapy followed of hematopoietic stem cells reinjection (HSC) is one therapeutic option which the profit is well demonstrated in the treatment of children's solid tumors. It's one of the "standard" treatment of the following tumors: neuroblastoma, metastatic medulloblastoma, Ewing sarcoma, lymphoma in relapse; and because of the big chemosensibility of paediatric cancers, stays an important therapeutic option in the rhabdomyosarcoma in relapse or metastatic, nephroblastoma, etc. The stem cells can be taken in the blood by cytapheresis after mobilization with pharmacologic molecules. At present, the reference of the mobilization treatment is the G-CSF (Granulocyte colony-stimulating factor) in monotherapy during 4 to 6 days. His inconveniences are: lasted of the treatment (4 to 6 days), reproduction of the injections (1 to 2 subcutaneous injections daily), day variability of the peak of mobilization, this hematopoietic stimulation imposes to delay the chemotherapy. The plerixafor activates a massive and fast mobilization of the HSC ( hematopoietic stem cells)(between 6 and 11 hours after the injection). Currently, it's indicated in association with the G-CSF ( Granulocyte colony-stimulating factor)in case of mobilization failure. However, his big flexibility of use could be of a big interest in monotherapy at the child. To date, there is in our knowledge no data on the use of this molecule at the child.
Schema of study: Subcutaneous injection of 240 µg/kg of Plerixafor (Mozobil ®, Genzyme) at 8 am the day of the cytapheresis. Determination of CD34+ cells circulating in h0 then every hour of h3 to h11. Taking by cytapheresis from the 5th hour of the injection if the rate of CD34+ is upper or equal in 10.106/l. If the rate of CD34+ in the blood does not reach 10.106/l after the first injection of plerixafor or if the first cytapheresis does not allow the collection of at least 5.106/kg CD34+ cells, the patient will be considered in failure and a conventional mobilization by G-CSF(Granulocyte colony-stimulating factor) will be programmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 0 to 18 years old
- Solid malign tumor
- Lansky score ≥ 70%
- Indication of hematopoietic stem cell taking by cytapheresis for extensive chemotherapy followed by one or several reinjections of hematopoietic stem cells
Key exclusion criteria (4 listed)
- Administration of hematopoietic growth factors in 8 days preceding the injection of Plerixafor.
- Contraindication in the cytapheresis or in the extensive chemotherapy.
- Clinical or biological state dissuading the realization of the cytapheresis
- Chemotherapy in 15 days preceding the injection of plerixafor or neutrophils < 1500/mm3
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 |
|---|---|---|
| Plerixafor, mozobilSubcutaneous injection of 240 µg/kg of Plerixafor (Mozobil ®, Genzyme) at 8 am the day of the cytapheresis. Determination of CD34+ cells circulating in h0 then every hour of h3 to h11. Taking by cytapheresis from the 5th hour of the injection if the rate of CD34+ is upper or equal in 10.106/l. If the rate of CD34+ in the blood does not reach 10.106/l after the first injection of plerixafor or if the first cytapheresis does not allow the collection of at least 5.106/kg CD34+ cells, the patient will be considered in failure and a conventional mobilization by G-CSF will be programmed | Drug | – |
Primary outcome
Percentage of the children to whom 5.106 cells CD34 + / kg can be collected in 2 masses blood treated (one cytapheresis).
Time frame: between H4 and H9 at day 0
5 secondary outcomes
Describe the kinetics of mobilization of the hematopoietic progenitor at the child in situation of hematopoietic stable state after a subcutaneous injection of plerixafor
Time frame: between the injection and the apheresis at day 0
Describe the pharmacokinetics of the plerixafor at the child
Time frame: between the injection and the apheresis at day 0
Describe the side effects
Time frame: day 0 to day 3
Describe the capacity of hematopoietic reconstruction of taken cells after mobilization by plerixafor only
Time frame: during the 30 following days
the toxicity of the plerixafor at the child.
Time frame: day 0 to day 3
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 8 Jul 2014.
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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.
Etienne MERLIN principal investigator
University Hospital, Clermont-Ferrand
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, mozobil in people with Children Cancer, Solid Tumor, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 8 Jul 2014. 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 France. 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?
Percentage of the children to whom 5.106 cells CD34 + / kg can be collected in 2 masses blood treated (one cytapheresis). (time frame: between H4 and H9 at day 0). 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 8 Jul 2014.