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Recruiting

NCT Number: NCT04263857

Register of Blood Stem Cell Transplantation

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

Recruiting

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Key information

Conditions

Hematologic Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar der TU München

Munich, 81675, Germany

Location status: Recruiting

Location contact

Mareike Verbeek, MD

CONTACT

[email protected]

+49 89 4140 ext. 5336

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed IC
  • patients eligible for stem cell transplantation

Exclusion criteria

  • unable to consent to study participation

Treatment and study plan

Primary outcomes

  1. Register of stem cell transplantation

    Time frame: approximately over 20 years

    Recording of all stem cell transplantations over many years

Secondary outcomes

  1. Register of toxicities

    Time frame: approximately over 20 years

    Recording of toxicities occured during and after SCT according to GvHD Score Standards and blood and bone marrow samples, and Imaging (CT Scans)

  2. Register of complications

    Time frame: approximately over 20 years

    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)

  3. Register of morbidities

    Time frame: approximately over 20 years

  4. Register of survivals

    Time frame: approximately over 20 years

    Recording of survival Status, Assessment of Remission Status by bone marrow and blood diagnostics, clinical follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Mareike Verbeek, MD

CONTACT

[email protected]

+49 89 4140 ext. 5336

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: REBB3M

Important dates

Study start
2017
Primary completion
2037
Study completion
2037
First posted
Feb 11, 2020
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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