Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC) - Full Text View

Sponsored by:	University Hospital Freiburg
Information provided by:	University Hospital Freiburg
ClinicalTrials.gov Identifier:	NCT00682799

Purpose

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:

To study hematopoietic chimerism in whole blood and different cell population (CD14, CD15, CD 56, CD3, CD19) as well as in dendritic cells and regulatory T-cells after SCT with RIC in patients with RC
To compare the results of chimerism obtained with standard STR PCR (sensitivity 1%) with those obtained with SNP PCR (sensitivity 0.1- 0.01%)

Secondary objectives:

To evaluate the relationship between mixed chimerism and hematological engraftment, OS and EFS
To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T-cells on the incidence of acute and chronic GVHD

Condition
Refractory Cytopenia (RC) Reduced Intensity Conditioning (RIC) Myelodysplastic Syndrome (MDS) Hematopoietic Stem Cell Transplantation (SCT)

U.S. FDA Resources

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

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:

To study hematopoietic chimerism in whole blood and different cell population (CD14, CD15, CD 56, CD3, CD19) as well as in dendritic cells and regulatory T-cells after SCT with RIC in patients with RC [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To compare the results of chimerism obtained with standard STR PCR (sensitivity 1%) with those obtained with SNP PCR (sensitivity 0.1- 0.01%) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the relationship between mixed chimerism and hematological engraftment, OS and EFS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T-cells on the incidence of acute and chronic GVHD [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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

Eligibility

Ages Eligible for Study:	up to 215 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

Inclusion Criteria:

RC patients enrolled in this study are to meet the following Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682799

Contacts

Contact: Charlotte M. Niemeyer, M.D.

49-761-270 ext 4506

charlotte.niemeyer@uniklinik-freiburg.de

Locations

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.

Sponsors and Collaborators

University Hospital Freiburg

Investigators

Principal Investigator:

Peter Bader, M.D.

University Children´s Hospital Frankfurt am Main

More Information

Homepage of the EWOG-MDS-Study Group This link exits the ClinicalTrials.gov site

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
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:

RC
RIC
MDS
SCT

Study placed in the following topic categories:

Myelodysplastic syndromes
Preleukemia
Precancerous Conditions
Hematologic Diseases

Myelodysplasia
Myelodysplastic Syndromes
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009