Acute LeukemiasPhase 1/2NCT01919866
Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells
A Phase 1/2 study testing Transplantation of CD3/CD19 depleted stem cells in people with Acute Leukemias and Aplastic Anemia, run by University Children's Hospital Tuebingen at 5 sites in 2 countries.
Trial summary
Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Acute Leukemias, Aplastic Anemia, Childhood Solid Tumor
- What is being tested?
- Transplantation of CD3/CD19 depleted stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Mar 2004to Dec 2015
- Phase
- Phase 1/2
- 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 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease)
- AML in complete remission of refractory
- MDS RAEB-t/secondary AML
- ALL
- CML
- Non-Hodgkin Lymphoma / Hodgkin Lymphoma
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- non malignant diseases (aplastic anemia, thalassemia, SCID)
- relapsed Neuroblastoma
- relapsed soft tissue sarcoma (Rhabdomyosarcoma, Ewing sarcoma, PNET
- soft tissue sarcoma with primary bone metastases or bone marrow
- in whom no matched donor was available,
Who cannot join
- < 6 months after previous HSCT
- active cerebral seizure conditions
- massive progression of leukemias or solid tumours before planned trp.
- left ventricular ejection fraction <25%
- creatinine clearance <40ml/min before conditioning
- respiratory insufficiency with oxygen demand or DLCO <30%
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- Bilirubin >4mg/dl, GOT/GPT >400
- severe infection (HIV, Aspergillosis)
- pregnancy
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites, 4 recruiting
- Recruiting
University Children's Hospital
Halle, 6120
Christine Mauz-Körholz, MD, christine.mauz-koerholz@medizin.uni-halle
- Recruiting
Medizinische Hochschule Zentrum für Kinderheilkunde
Hanover, 30625
Martin Sauer, MD, sauer.martin@mh-hannover.de
- Recruiting
University Children's Hospital
Jena, 7745
Bernd Gruhn, MD, bernd.gruhn@med.uni-jena.de
- Recruiting
University Children's Hospital
Tübingen, 72076
Peter Lang, MD
Austria1 site, 1 recruiting
- Recruiting
University Children's Hospital
Graz, 8036
Christian Urban, MD, christian.urban@medunigraz.at
About this study
Official title: Haploidentical Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells in Pediatric Patients With Refractory Hematological and Oncological Diseases
Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.
- Conditions
- Acute Leukemias, Aplastic Anemia, Childhood Solid Tumor
- Being tested
- Transplantation of CD3/CD19 depleted stem cells
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation of CD3/CD19 depleted stem cellsOther
| Study group | Role | What they receive |
|---|---|---|
| Transplantation of CD3/CD19 depleted stem cells | Experimental | Patients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW Receives: Other: Transplantation of CD3/CD19 depleted stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment rate and transplant related mortality
engraftment rate will be evaluated by leukocyte counts in peripheral blood . Definition of engraftment: >500 neutrophiles/µl blood. Transplant related mortality will be evaluated at day 100 and day 365 post transplant
Measured: 365 days
Secondary outcomes (1)
Graft versus Host disease and speed of immune reconstitution
Incidence of acute and chronic GvHD will be evaluated according to Glucksberg criteria. Immune recovery will be evaluated by flow cytometry. Percentages and numbers of T, B and NK cells will be measured weekly until day 100, afterwards on day 180 and 365.
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startMar 2004
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiasStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lang, University Children's Hospital Tuebingen
- Investigators
- Peter Lang, MD, Principal investigator, University Children's Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919866
- Sponsor's protocol ID
- 1075/01 PEI
- Status last verified
- Oct 2014
- First submitted
- 7 Aug 2013
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haploidentical Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells in Pediatric Patients With Refractory Hematological and Oncological Diseases
- ClinicalTrials.gov ID
- NCT01919866
- Acronym / sponsor ID
- 1075/01 PEI
- Conditions
- Acute Leukemias, Aplastic Anemia, Childhood Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Children's Hospital TuebingenUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Aug 2013 (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.
Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplantation of CD3/CD19 depleted stem cells | Experimental | Other: Transplantation of CD3/CD19 depleted stem cellsPatients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW |
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease)
- AML in complete remission of refractory
- MDS RAEB-t/secondary AML
- ALL
- CML
Key exclusion criteria (9 listed)
- < 6 months after previous HSCT
- active cerebral seizure conditions
- massive progression of leukemias or solid tumours before planned trp.
- left ventricular ejection fraction <25%
- creatinine clearance <40ml/min before conditioning
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 |
|---|---|---|
| Transplantation of CD3/CD19 depleted stem cells | Other | Transplantation of CD3/CD19 depleted stem cells |
Primary outcome
Engraftment rate and transplant related mortality
Time frame: 365 days
engraftment rate will be evaluated by leukocyte counts in peripheral blood . Definition of engraftment: >500 neutrophiles/µl blood. Transplant related mortality will be evaluated at day 100 and day 365 post transplant
1 secondary outcome
Graft versus Host disease and speed of immune reconstitution
Time frame: 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
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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 Lang, MD principal investigator
University Children's Hospital Tuebingen
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transplantation of CD3/CD19 depleted stem cells in people with Acute Leukemias and Aplastic Anemia, run by University Children's Hospital Tuebingen at 5 sites in 2 countries.
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 11 inclusion and 9 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 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Austria. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Peter Lang, MD (+4970712981386, peter.lang@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment rate and transplant related mortality (time frame: 365 days). 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 8 Oct 2014.