Hematologic MalignanciesPhase 1/2NCT00202917
Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies
A Phase 1/2 study testing Fludarabine, Thiotepa and Melphalan in people with Hematologic Malignancies, run by University Hospital Tuebingen at 7 sites in Germany.
Trial summary
The purpose of this study is to study the feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Fludarabine, Thiotepa and Melphalan
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 7 sitesGermany
- Study dates
- Feb 2004to Dec 2010
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age <60, >18 years
- Karnofsky >60%
- High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with:
- ALL
- AML
- PNH
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- MDS (RAEB-t/secondary AML)
- NHL
- ALL
- HD
- CML
- MM
- No HLA-identical MRD or URD if not preceding allo-HCT
- Use haploidentical donor with KIR-Mismatch if choice
Who cannot join
- < 3 months after preceding HCT
- Active cerebral seizures
- > 30% blasts in BM if ALL/AML/CML-BC
- Completely chemo-refractory
- Preceding myocardial infarction
- Ejection fraction <30 % echocardiography
Show all 12Show fewer
- Creatinine clearance <50 ml/min
- Respiratory insufficiency on supplemental O2 or DLCO < 30%
- Allergy against murine antibodies
- HIV infection
- Pregnancy
- Unable for informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
University of Dresden Medical Center
Dresden, D-01307
Center for Marrow Transplantation
Essen, 45122
Medical Center University of Hamburg
Hamburg, 20246
Medical Center University of Muenster
Münster, 48129
South West German Cancer Center, University of Tuebingen Medical Center
Tübingen, 72076
Deutsche Klinik für Diagnostik
Wiesbaden, 65191
University of Wuerzburg Medical Center
Würzburg, D-97070
About this study
Official title: Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies
The purpose of this study is to study the feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning.
Read the detailed description
Transplantation of a CD3/CD19 depleted stem cell grafts after dose reduced conditioning for the treatment of treatment refractory or relapsed hematologic malignancies after preceding allogeneic or autologous hematopoietic cell transplantation.
- Conditions
- Hematologic Malignancies
- Being tested
- Fludarabine, Thiotepa, Melphalan, OKT-3, CD3/CD19 depletion on CliniMACS
- Keywords
- haploidentical transplantation, immunomagnetic cell sorting, allogeneic hematopoietic cell transplantation, dose reduced conditioning
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
ThiotepaDrug
MelphalanDrug
OKT-3Drug
CD3/CD19 depletion on CliniMACSProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment
Toxicity
Mortality and Morbidity
Secondary outcomes (5)
Infections
GVHD
Immune reconstitution
Disease response
Long term toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionJul 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Wolfgang A Bethge, MD, Principal investigator, University of Tuebingen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202917
- Sponsor's protocol ID
- E203/2004
- Other IDs
- IRB Project Nr. 21/2004, HSZ-001
- Status last verified
- May 2014
- First submitted
- 12 Sep 2005
- Last updated
- 29 May 2014
- Results posted
- No
Publications
Federmann B, Bornhauser M, Meisner C, Kordelas L, Beelen DW, Stuhler G, Stelljes M, Schwerdtfeger R, Christopeit M, Behre G, Faul C, Vogel W, Schumm M, Handgretinger R, Kanz L, Bethge WA. Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: a phase II study. Haematologica. 2012 Oct;97(10):1523-31. doi: 10.3324/haematol.2011.059378. Epub 2012 Apr 4.
PubMed 22491731
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00202917
- Acronym / sponsor ID
- E203/2004
- Conditions
- Hematologic Malignancies
- Keywords
- haploidentical transplantation, immunomagnetic cell sorting, allogeneic hematopoietic cell transplantation, dose reduced conditioning
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 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.
The purpose of this study is to study the feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning.
Detailed description
Transplantation of a CD3/CD19 depleted stem cell grafts after dose reduced conditioning for the treatment of treatment refractory or relapsed hematologic malignancies after preceding allogeneic or autologous hematopoietic cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age <60, >18 years
- Karnofsky >60%
- High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with:
- ALL
- AML
Key exclusion criteria (12 listed)
- < 3 months after preceding HCT
- Active cerebral seizures
- > 30% blasts in BM if ALL/AML/CML-BC
- Completely chemo-refractory
- Preceding myocardial infarction
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 | Drug | – |
| Thiotepa | Drug | – |
| Melphalan | Drug | – |
| OKT-3 | Drug | – |
| CD3/CD19 depletion on CliniMACS | Procedure or surgery | – |
Primary outcome
Engraftment
Toxicity
Mortality and Morbidity
5 secondary outcomes
Infections
GVHD
Immune reconstitution
Disease response
Long term toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Derived from this study: PubMed 22491731Federmann B, Bornhauser M, Meisner C, Kordelas L, Beelen DW, Stuhler G, Stelljes M, Schwerdtfeger R, Christopeit M, Behre G, Faul C, Vogel W, Schumm M, Handgretinger R, Kanz L, Bethge WA. Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: a phase II study. Haematologica. 2012 Oct;97(10):1523-31. doi: 10.3324/haematol.2011.059378. Epub 2012 Apr 4.
- Related InfoLink provided by the sponsor.
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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.
Wolfgang A Bethge, MD principal investigator
University of Tuebingen Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fludarabine, Thiotepa and Melphalan in people with Hematologic Malignancies, run by University Hospital Tuebingen at 7 sites 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 14 inclusion and 12 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: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Engraftment. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00202917, which also lists 1 linked publication.
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 29 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.