Register of Blood Stem Cell Transplantation

Hematologic Malignancies Clinical Trial

— REBB3M  

Official title:

Register of Survey and Evaluation of Blood Stem Cell Transplantations of Clinic III of Internal Medicine III

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263857
• Other study ID #: REBB3M
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms

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