Children Treated With High-Dose Chemotherapy (HDC) Followed by Haematopoietic Stem Cell Transplantation (HSCT)Phase 3NCT00180986
Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child
A Phase 3 study testing Platelet concentrates in people with Children Treated With High-Dose Chemotherapy (HDC) Followed by Haematopoietic Stem Cell Transplantation (HSCT), run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Children Treated With High-Dose Chemotherapy (HDC) Followed by Haematopoietic Stem Cell Transplantation (HSCT)
- What is being tested?
- Platelet concentrates
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 1995to not given
- Phase
- Phase 3
- 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 0 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children weighing 30 kg or less with a diagnosis of haematological malignancy or solid tumour, who were candidates for HSCT were eligible for inclusion in the study.
- Written informed consent was required from parents of eligible children.
Who cannot join
- Children were excluded if they had a anti-HLA and/or anti-HPA antibody, if they were prior included in this study or if the parents declined to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child
- Being tested
- Platelet concentrates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet concentratesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of the study was tocompare the number of platelet concentrates donors who were implicated in platelet transfusion supportive after HSCT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Treated With High-Dose Chemotherapy (HDC) Followed by Haematopoietic Stem Cell Transplantation (HSCT)Studies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- Valérie LAPIERRE, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180986
- Sponsor's protocol ID
- Minnie
- Other IDs
- CSET 94/357
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 14 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child
- ClinicalTrials.gov ID
- NCT00180986
- Acronym / sponsor ID
- Minnie
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Oct 1995
- First posted
- 16 Sep 2005 (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.
Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children weighing 30 kg or less with a diagnosis of haematological malignancy or solid tumour, who were candidates for HSCT were eligible for inclusion in the study.
- Written informed consent was required from parents of eligible children.
Key exclusion criteria (1 listed)
- Children were excluded if they had a anti-HLA and/or anti-HPA antibody, if they were prior included in this study or if the parents declined to participate.
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 |
|---|---|---|
| Platelet concentrates | Procedure or surgery | – |
Primary outcome
The primary end point of the study was tocompare the number of platelet concentrates donors who were implicated in platelet transfusion supportive after HSCT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2005.
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.
Valérie LAPIERRE, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet concentrates in people with Children Treated With High-Dose Chemotherapy (HDC) Followed by Haematopoietic Stem Cell Transplantation (HSCT), run by Gustave Roussy, Cancer Campus, Grand Paris 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 2 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 14 Dec 2005. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
The primary end point of the study was tocompare the number of platelet concentrates donors who were implicated in platelet transfusion supportive after HSCT.. 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 14 Dec 2005.