Malignant and Non-malignant High Risk DiseasesPhase 2NCT00945126
Allogeneic Stem Cell Transplantation in Pediatric Patients With Malignant and Non-malignant High-risk Diseases
A Phase 2 study testing Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACS in people with Malignant and Non-malignant High Risk Diseases, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The aim of the study is to investigate the feasibility and toxicity of allogeneic haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with a reduced or a standard conditioning regimen in pediatric patients with malignant and non-malignant high-risk diseases, for whom allogeneic… Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Malignant and Non-malignant High Risk Diseases
- What is being tested?
- Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACS
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Aug 2017
- 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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 0 to 30 years
- Written informed consent from patient and/or parents or guardian
- Patients with Karnofsky Index > 60%
- Malignant disease:
- acute lymphoblastic leukemia
- acute myeloid leukemia
Show all 13Show fewer
- myelodysplastic syndrome
- chronic myeloid leukemia according to the standard indications
- solid tumors (e.g. neuroblastoma recurrence, soft-tissue sarcoma, Ewing's sarcoma, osteosarcoma, hepatoblastoma)
- . Non malignant disease:
- acquired anemias (e.g. severe aplastic anemia, particularly severe Evans syndrome)
- congenital anemias (e.g. thalassemia and sickle cell anemia)
- Women reliable contraception method when appropriate
Who cannot join
- Participation in other clinical trials
- Patients, parents, or guardians unable to understand the nature, the importance and the implications of the procedure
- Pregnant or nursing women
- Patients who underwent a stem cell transplantation in the last 250 days
- Patients with kidney, heart or liver insufficiency
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Frankfurt, Dept. for Children and Adolescents, Division for Stem Cell Transplantation, Goethe University
Frankfurt am Main, Hesse, 60590
About this study
Official title: Allogeneic Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells of Related or Unrelated Haploidentical Donors in Pediatric Patients With Malignant and Non-malignant Diseases
The aim of the study is to investigate the feasibility and toxicity of allogeneic haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with a reduced or a standard conditioning regimen in pediatric patients with malignant and non-malignant high-risk diseases, for whom allogeneic stem cell transplantation represents the only possible therapy option and no human leukocyte antigen (HLA) compatible related donors are available.
- Being tested
- Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACS
- Keywords
- Allogeneic stem cell transplantation in pediatric patients, CD3/CD19 depleted stem cells, malignant and non-malignant high risk diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACSOther
The aim is to transplant 7x106 CD34+/kg of recipient body weight.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate engraftment after CD3/CD19 depletion of the graft
Measured: within 1 year
Secondary outcomes (1)
To evaluate immunoreconstitution after transplantation by assessing lymphocyte subsets
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startDec 2006
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Poor accrural
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant and Non-malignant High Risk DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Bader, Johann Wolfgang Goethe University Hospital
- Investigators
- Peter Bader, Professor, Principal investigator, University Hospital Frankfurt, Dept. for Children and Adolescents, Division for Stem Cell Transplantation, Goethe University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945126
- Sponsor's protocol ID
- ZKI-SCT-HAPLO-0106
- Status last verified
- Aug 2018
- First submitted
- 21 Jul 2009
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells of Related or Unrelated Haploidentical Donors in Pediatric Patients With Malignant and Non-malignant Diseases
- ClinicalTrials.gov ID
- NCT00945126
- Acronym / sponsor ID
- ZKI-SCT-HAPLO-0106
- Keywords
- Allogeneic stem cell transplantation in pediatric patients, CD3/CD19 depleted stem cells, malignant and non-malignant high risk diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrural
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 23 Jul 2009 (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.
The aim of the study is to investigate the feasibility and toxicity of allogeneic haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with a reduced or a standard conditioning regimen in pediatric patients with malignant and non-malignant high-risk diseases, for whom allogeneic stem cell transplantation represents the only possible therapy option and no human leukocyte antigen (HLA) compatible related donors are available.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Patients aged 0 to 30 years
- Written informed consent from patient and/or parents or guardian
- Patients with Karnofsky Index > 60%
- Malignant disease:
- Women reliable contraception method when appropriate
Key exclusion criteria (5 listed)
- Participation in other clinical trials
- Patients, parents, or guardians unable to understand the nature, the importance and the implications of the procedure
- Pregnant or nursing women
- Patients who underwent a stem cell transplantation in the last 250 days
- Patients with kidney, heart or liver insufficiency
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 |
|---|---|---|
| Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACSThe aim is to transplant 7x106 CD34+/kg of recipient body weight. | Other | – |
Primary outcome
To evaluate engraftment after CD3/CD19 depletion of the graft
Time frame: within 1 year
1 secondary outcome
To evaluate immunoreconstitution after transplantation by assessing lymphocyte subsets
Time frame: within 1 year
Results and safety
The study was stopped early (reason given: Poor accrural). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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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.
Peter Bader, Professor principal investigator
University Hospital Frankfurt, Dept. for Children and Adolescents, Division for Stem Cell Transplantation, Goethe University.
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 Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACS in people with Malignant and Non-malignant High Risk Diseases, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 13 inclusion and 5 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 15 Aug 2018. 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 Germany. 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 was stopped early (reason given: Poor accrural). 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?
To evaluate engraftment after CD3/CD19 depletion of the graft (time frame: within 1 year). 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 15 Aug 2018.