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Sponsored by: |
University Hospital Freiburg |
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Information provided by: | University Hospital Freiburg |
ClinicalTrials.gov Identifier: | NCT00682799 |
This is a prospective, non-randomized multi-center multi-national study to evaluate the chimerism measured by STR and SNP in patients with hypoplastic RC and normal karyotype transplanted with a preparative regimen of reduced intensity.
Primary objectives:
Secondary objectives:
Condition |
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Refractory Cytopenia (RC) Reduced Intensity Conditioning (RIC) Myelodysplastic Syndrome (MDS) Hematopoietic Stem Cell Transplantation (SCT) |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC) EWOG MDS SCT RC RIC-06 |
Hematopoietic chimerism will be investigated from PB samples. Prior to transplant 5 ml EDTA PB from patient and donor are required and will be sent to the laboratory of the Coordinating Investigator (P.B.). Post transplant PB samples (5 -10 ml EDTA blood) from day +30 (4 days), +60(4 days), +100 (7 days) and +180 (7 days) will also being sent to the laboratory of the Coordinating Investigator (P.B.) From EDTA PB cell subpopulations will be isolated and DNA will be extracted and stored for further investigations.
Estimated Enrollment: | 70 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | March 2013 |
Ages Eligible for Study: | up to 215 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients will only be allowed to enter the trial if they or their caretakers provide written informed consent about their participation (following full explanation of the trial) and if the physician has verified that the patient meets all of the Inclusion Criteria and none of the Exclusion Criteria.
Inclusion Criteria:
RC patients enrolled in this study are to meet the following Inclusion Criteria:
Exclusion Criteria:
Patients who do not fulfill the Inclusion Criteria may not be included into study. Specific Exclusion Criteria are:
Contact: Charlotte M. Niemeyer, M.D. | 49-761-270 ext 4506 | charlotte.niemeyer@uniklinik-freiburg.de |
Germany, Hessen | |
University Children´s Hospital | Recruiting |
Frankfurt am Main, Hessen, Germany, 60590 | |
Contact: Peter Bader, M.D. 49-69-63017542 peter.bader@kgu.de | |
Principal Investigator: Peter Bader, M.D. |
Principal Investigator: | Peter Bader, M.D. | University Children´s Hospital Frankfurt am Main |
Responsible Party: | University Children´s Hospital, Department of Pediatric Hematology /Oncology, Frankfurt am Main ( Peter Bader, M.D. ) |
Study ID Numbers: | EWOG MDS SCT RC RIC-06 |
Study First Received: | May 16, 2008 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00682799 History of Changes |
Health Authority: | Germany: Ethics Commission |
RC RIC MDS SCT |
Preleukemia Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Bone Marrow Diseases |
Neoplasms Preleukemia Precancerous Conditions |
Hematologic Diseases Myelodysplastic Syndromes Bone Marrow Diseases |