Solid MalignanciesPhase 2MEG-5NCT00751894
Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)
A Phase 2 study testing Pegfilgrastim (Neulasta, Amgen) in people with Solid Malignancies, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Solid Malignancies
- What is being tested?
- Pegfilgrastim (Neulasta, Amgen)
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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
- solid malignancy
- Lansky score >70%
- 12 to 18 days since the beginning of the last chemotherapy cycle
- no administration of any hematopoietic growth factor in the previous 8 days
Who cannot join
- clinical or biological conditions precluding the mobilization or collection procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy
Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed
Read the detailed description
Patients: consecutively referred for HSC mobilization. 12 to 18 days after the previous chemotherapy. No haematological growth factor during the 8 previous days.
Mobilization: one sc injection of 200 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation during the study: CD34 circulating cells from day 3 to day 7 ; AE recording Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) Analysis: sequential Bayesian study
- Conditions
- Solid Malignancies
- Being tested
- Pegfilgrastim (Neulasta, Amgen)
- Keywords
- Children, cancer, Bone marrow transplantation, Stem cell mobilization, G-CSF, Children with solid malignancies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegfilgrastim (Neulasta, Amgen)Drug
sequential Bayesian study
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed)
Measured: less than 3 blood volume processed
Secondary outcomes (1)
Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells
Measured: at least 5*10e6CD34cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid MalignanciesStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Investigators
- Etienne Merlin, DR, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751894
- Sponsor's protocol ID
- CHU-0041
- Acronym
- MEG-5
- Status last verified
- Jan 2011
- First submitted
- 11 Sep 2008
- Last updated
- 19 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy
- ClinicalTrials.gov ID
- NCT00751894
- Acronym / sponsor ID
- MEG-5 / CHU-0041
- Conditions
- Solid Malignancies
- Keywords
- Children, cancer, Bone marrow transplantation, Stem cell mobilization, G-CSF, Children with solid malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Amgen
- First posted
- 12 Sep 2008 (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.
Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed
Detailed description
Patients: consecutively referred for HSC mobilization. 12 to 18 days after the previous chemotherapy. No haematological growth factor during the 8 previous days.
Mobilization: one sc injection of 200 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation during the study: CD34 circulating cells from day 3 to day 7 ; AE recording Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) Analysis: sequential Bayesian study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (5 listed)
- 0 to 18 years
- solid malignancy
- Lansky score >70%
- 12 to 18 days since the beginning of the last chemotherapy cycle
- no administration of any hematopoietic growth factor in the previous 8 days
Key exclusion criteria (1 listed)
- clinical or biological conditions precluding the mobilization or collection procedure
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 |
|---|---|---|
| Pegfilgrastim (Neulasta, Amgen)sequential Bayesian study | Drug | – |
Primary outcome
percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed)
Time frame: less than 3 blood volume processed
1 secondary outcome
Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells
Time frame: at least 5*10e6CD34cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
Related trials for Solid Malignancies
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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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, DR 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 Pegfilgrastim (Neulasta, Amgen) in people with Solid Malignancies, 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jan 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Lacarin (04.73.75.11.95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) (time frame: less than 3 blood volume processed). 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 Jan 2011.