Solid TumorsPhase 2RICENCT00750126
Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Fludarabine, Busulfan, Thymoglobulin in people with Solid Tumors and Hematologic Neoplasms, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
To assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation chimerism and hematological reconstitution. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Solid Tumors, Hematologic Neoplasms
- What is being tested?
- Fludarabine, Busulfan, Thymoglobulin
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Apr 2009
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged less than 20 years old
- Lansky score > 60%
- Life expectancy greater than 2 months
- Diagnoses:
- 3- Solid tumor or hematological malignancy remaining unresponsive to the reference strategies according to French best practices in pediatrics.
- 4- Malignancies for which allografting is the recognized indication but is contraindicated with myeloablative conditioning.
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- Usual criteria for allogeneic grafting (pre-graft profile)
- Having a HLA-identical sibling donor for HLA-A, HLA-B and HLA-DR antigens or a HLA mismatch on only one antigen, or having a 10/10 pheno-identical donor, or compatible cord blood.
- Signed informed consent
Who cannot join
- Patient presenting rapidly-progressive malignancy
- In cases where the potential donor is related, sibling presenting contraindication against hematopoietic stem cell donation
- Unable to sufficiently understand the treatment and its consequences, even after explanation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Paillard Catherine
Clermont-Ferrand, 63003
Paillard Catherine, Dr, cpaillard@chu-clermontferrand.fr
About this study
Official title: Feasibility Study on Allogeneic Hematopoietic Stem Cell Transplantation Following Fludarabine-Busulfan-ALS-based Reduced-intensity Conditioning in Children With Hematological Malignancy or Solid Tumor Not Responding to Standard Therapy or for Which the Indication for Allograft is Maintained But Cannot be Carried Out Due to the Toxicity Involved in Myeloablative Conditioning.
To assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation chimerism and hematological reconstitution.
To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post-transplantation To study the effectiveness of the protocol on tumor response.
To study overall survival.
Read the detailed description
Primary criterion
- Hematological reconstitution and chimerism post-transplantation
Secondary criteria
- Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
- Analysis of variations in post-transplantation immunological function profiles
- Median duration of response in therapy-responsive patients and median duration of stability in stabilized patients
- Conditions
- Solid Tumors, Hematologic Neoplasms
- Being tested
- Fludarabine, Busulfan, Thymoglobulin
- Keywords
- Allograft, Children, malignancy, Reduced Intensity Conditioning, Fludarabin, Busulfex, Thymoglobulin
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine, Busulfan, ThymoglobulinDrug
study :
- acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post transplantation
- the effectiveness of the protocol on tumor response
- overall survival
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary criterion - Hematological reconstitution and chimerism post-transplantation
Measured: post-transplantation
Secondary outcomes (1)
Secondary criteria - Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
Measured: post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Paillard Catherine, Dr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750126
- Sponsor's protocol ID
- CHU-0039
- Acronym
- RICE
- Status last verified
- Jan 2011
- First submitted
- 9 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
- Feasibility Study on Allogeneic Hematopoietic Stem Cell Transplantation Following Fludarabine-Busulfan-ALS-based Reduced-intensity Conditioning in Children With Hematological Malignancy or Solid Tumor Not Responding to Standard Therapy or for Which the Indication for Allograft is Maintained But Cannot be Carried Out Due to the Toxicity Involved in Myeloablative Conditioning.
- ClinicalTrials.gov ID
- NCT00750126
- Acronym / sponsor ID
- RICE / CHU-0039
- Conditions
- Solid Tumors, Hematologic Neoplasms
- Keywords
- Allograft, Children, malignancy, Reduced Intensity Conditioning, Fludarabin, Busulfex, Thymoglobulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 10 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.
To assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation chimerism and hematological reconstitution.
To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post-transplantation To study the effectiveness of the protocol on tumor response.
To study overall survival.
Detailed description
Primary criterion
- Hematological reconstitution and chimerism post-transplantation
Secondary criteria
- Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
- Analysis of variations in post-transplantation immunological function profiles
- Median duration of response in therapy-responsive patients and median duration of stability in stabilized patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patients aged less than 20 years old
- Lansky score > 60%
- Life expectancy greater than 2 months
- Diagnoses:
- 3- Solid tumor or hematological malignancy remaining unresponsive to the reference strategies according to French best practices in pediatrics.
Key exclusion criteria (3 listed)
- Patient presenting rapidly-progressive malignancy
- In cases where the potential donor is related, sibling presenting contraindication against hematopoietic stem cell donation
- Unable to sufficiently understand the treatment and its consequences, even after explanation
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 |
|---|---|---|
| Fludarabine, Busulfan, Thymoglobulinstudy : * acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post transplantation * the effectiveness of the protocol on tumor response * overall survival | Drug | – |
Primary outcome
Primary criterion - Hematological reconstitution and chimerism post-transplantation
Time frame: post-transplantation
1 secondary outcome
Secondary criteria - Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
Time frame: post-transplantation
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.
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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.
Paillard Catherine, 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 Fludarabine, Busulfan, Thymoglobulin in people with Solid Tumors and Hematologic Neoplasms, 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 9 inclusion and 3 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 Lacarin Patrick (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?
Primary criterion - Hematological reconstitution and chimerism post-transplantation (time frame: post-transplantation). 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.