- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202917
Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies
May 28, 2014 updated by: University Hospital Tuebingen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dresden, Germany, D-01307
- University of Dresden Medical Center
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Essen, Germany, 45122
- Center for Marrow Transplantation
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Hamburg, Germany, 20246
- Medical Center University of Hamburg
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Muenster, Germany, 48129
- Medical Center University of Muenster
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Tuebingen, Germany, 72076
- South West German Cancer Center, University of Tuebingen Medical Center
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Wiesbaden, Germany, 65191
- Deutsche Klinik für Diagnostik
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Wuerzburg, Germany, D-97070
- University of Wuerzburg Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age <60, >18 years
- Karnofsky >60%
- High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with:
- ALL
- AML
- PNH
- 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
Exclusion Criteria:
- < 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
- Creatinine clearance <50 ml/min
- Respiratory insufficiency on supplemental O2 or DLCO < 30%
- Allergy against murine antibodies
- HIV infection
- Pregnancy
- Unable for informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Engraftment
|
Mortality and Morbidity
|
Secondary Outcome Measures
Outcome Measure |
---|
Infections
|
GVHD
|
Immune reconstitution
|
Disease response
|
Long term toxicity
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wolfgang A Bethge, MD, University of Tuebingen Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
May 29, 2014
Last Update Submitted That Met QC Criteria
May 28, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Hematologic Diseases
- Neoplasms
- Hematologic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Melphalan
- Fludarabine
- Thiotepa
Other Study ID Numbers
- E203/2004
- IRB Project Nr. 21/2004
- HSZ-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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