Status:
COMPLETED
Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)
Lead Sponsor:
Charlotte Niemeyer, MD
Conditions:
Refractory Cytopenia of Childhood
Reduced Intensity Conditioning (RIC)
Eligibility:
All Genders
Up to 215 years
Brief Summary
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 prepa...
Detailed Description
Research Question 3.1.1 Chimerism and post transplant outcome During the past 3 decades, SCT has become a well established treatment procedure for many malignant and hematopoietic disorders in childre...
Eligibility Criteria
Inclusion
- RC patients enrolled in this study are to meet the following
- RC Patients with hypocellular BM normal karyotype included in the EWOG-MDS 2006 protocol who receive SCT from a MFD or a compatible (8/8) or one allelic mismatch UD
- Written informed consent by the caretakers and whenever possible the patient's assent.
- Age less than 18 years The caretakers will have given their written informed consent to participate in the study. Consent will be documented by the caretaker's dated signature which will be also signed and dated by the investigator in the participating center. If the patient is able to understand the meaning and consequences of the study and its procedures his/her written informed assent is also needed. Written informed consent has to be obtained prior to enrollment into the study.
Exclusion
- Patients who do not fulfill the Inclusion Criteria may not be included into study. Specific Exclusion Criteria are:
- •Transplanted with a preparative regimen other than thiotepa, fludarabine
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00682799
Start Date
April 1 2007
End Date
March 1 2013
Last Update
January 15 2015
Active Locations (1)
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1
University Children´s Hospital
Frankfurt am Main, Hesse, Germany, 60590