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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04263857
Other study ID # REBB3M
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date November 2037

Study information

Verified date November 2023
Source Technical University of Munich
Contact Mareike Verbeek, MD
Phone +49 89 4140
Email mareike.verbeek@tum.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Register of patients with blood stem cell transplantations (autologous, allogen).


Description:

Documenting the success rate in terms of complication rate, disease response, survival rate, engraftment, and details of transplantation settings, for example donor and conditioning data, remission status before transplantation. It's a register of patients who have one or more autologous and / or allogenic blood stem cell transplants due to an existing indication for performing myeloablative / non-myeloablative high-dose chemotherapy. The inclusion occurs at our center during preparation for blood stem cell transplantation. The written consent will be obtained separately in the context of the information on blood stem cell transplantation. Participation is voluntary and consent can be revoked at any time. This involves no additional effort for the patient and has no influence on his treatment. It may be necessary in the course of contacting the patient at home, as long as the data is incomplete. This is also explicitly explained. A copy of the declaration of consent is given to the patient.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date November 2037
Est. primary completion date November 2037
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - signed IC - patients eligible for stem cell transplantation Exclusion Criteria: - unable to consent to study participation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Klinikum rechts der Isar der TU München Munich

Sponsors (1)

Lead Sponsor Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Register of stem cell transplantation Recording of all stem cell transplantations over many years approximately over 20 years
Secondary Register of toxicities Recording of toxicities occured during and after SCT according to GvHD Score Standards and blood and bone marrow samples, and Imaging (CT Scans) approximately over 20 years
Secondary Register of complications Recording of complications occurred during and after SCT in Terms of infectious complications and occurance of GvHD (according to GvHD Score and Imaging and clinical assessment) approximately over 20 years
Secondary Register of morbidities approximately over 20 years
Secondary Register of survivals Recording of survival Status, Assessment of Remission Status by bone marrow and blood diagnostics, clinical follow up approximately over 20 years
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