Solid MalignanciesPhase 2NCT00695370
Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children
A Phase 2 study testing Pegfilgrastim (drug) in people with Solid Malignancies, run by University Hospital, Clermont-Ferrand.
Trial summary
Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state 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 2 blood volume processed) 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 (drug)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jan 2008
- 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%
- more than 17 days since the beginning of the last chemotherapy cycle
- absolute neutrophil count (ANC) greater than 1×109/l
- 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
About this study
Official title: Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State
Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state 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 2 blood volume processed)
Read the detailed description
Patients: consecutively referred for HSC mobilization. At least 17 days after the previous chemotherapy. No hematological growth factor during the 8 previous days.
Mobilization: one sc injection of 300 µg/kg pegfilgrastim (Neulasta, Amgen)
Evaluation during the study: CD34 circulating cells from day 2 to day 7 ; AE recording
Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
Analysis: sequential Bayesian study
- Conditions
- Solid Malignancies
- Being tested
- Pegfilgrastim (drug)
- Keywords
- Children, cancer, Bone marrow transplantation, 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 (drug)Drug
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 2 blood volume processed)
Secondary outcomes (1)
Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2007 (estimated)
- Study completionJan 2008 (estimated)
Why it stopped: Recruiting or enrolling participants has halted and will not resume
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, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695370
- Sponsor's protocol ID
- CHU-0035
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2008
- Last updated
- 13 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State
- ClinicalTrials.gov ID
- NCT00695370
- Acronym / sponsor ID
- CHU-0035
- Conditions
- Solid Malignancies
- Keywords
- Children, cancer, Bone marrow transplantation, Mobilization, G-CSF, Children with solid malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting or enrolling participants has halted and will not resume
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (estimated)
- Study completion
- Jan 2008 (estimated)
- First posted
- 11 Jun 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 300 µg/kg in hematological steady state 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 2 blood volume processed)
Detailed description
Patients: consecutively referred for HSC mobilization. At least 17 days after the previous chemotherapy. No hematological growth factor during the 8 previous days.
Mobilization: one sc injection of 300 µg/kg pegfilgrastim (Neulasta, Amgen)
Evaluation during the study: CD34 circulating cells from day 2 to day 7 ; AE recording
Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 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 (6 listed)
- 0 to 18 years
- solid malignancy
- Lansky score >70%
- more than 17 days since the beginning of the last chemotherapy cycle
- absolute neutrophil count (ANC) greater than 1×109/l
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 (drug) | Drug | – |
Primary outcome
percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
1 secondary outcome
Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells
Results and safety
The study was stopped early (reason given: Recruiting or enrolling participants has halted and will not resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2008.
Related trials for Solid Malignancies
RecruitingPhase 1/2
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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
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, MD principal investigator
University Hospital, Clermont-Ferrand
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegfilgrastim (drug) in people with Solid Malignancies, run by University Hospital, Clermont-Ferrand.
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 6 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: stopped early, as of the sponsor's last update on 13 Jun 2008. 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.
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 was stopped early (reason given: Recruiting or enrolling participants has halted and will not resume). Results are not available in the source record.
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 children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 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 13 Jun 2008.