Hematologic MalignanciesREBB3MNCT04263857
Register of Blood Stem Cell Transplantation
An observational study of Hematologic Malignancies, run by Technical University of Munich at 1 site in Germany.
Trial summary
Register of patients with blood stem cell transplantations (autologous, allogen). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to Nov 2037
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all adults, Age >= 18 years
Who may be able to join
- signed IC
- patients eligible for stem cell transplantation
Who cannot join
- unable to consent to study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar der TU München
Munich, 81675
Mareike Verbeek, MD, +49 89 4140 ext. 5336, mareike.verbeek@tum.de
About this study
Official title: Register of Survey and Evaluation of Blood Stem Cell Transplantations of Clinic III of Internal Medicine III
Register of patients with blood stem cell transplantations (autologous, allogen).
Read the detailed 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.
- Conditions
- Hematologic Malignancies
- Keywords
- autologous & allogenic blood stem cell transplantations
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Register of stem cell transplantation
Recording of all stem cell transplantations over many years
Measured: approximately over 20 years
Secondary outcomes (4)
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)
Measured: approximately over 20 years
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)
Measured: approximately over 20 years
Register of morbidities
Measured: approximately over 20 years
Register of survivals
Recording of survival Status, Assessment of Remission Status by bone marrow and blood diagnostics, clinical follow up
Measured: approximately over 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Nov 2017
- Primary completionNov 2037 (estimated)
- Study completionNov 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mareike Verbeek, MD, Principal investigator, Klinikum rechts der Isar der TU Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263857
- Sponsor's protocol ID
- REBB3M
- Acronym
- REBB3M
- Status last verified
- Nov 2023
- First submitted
- 2 Mar 2018
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register of Survey and Evaluation of Blood Stem Cell Transplantations of Clinic III of Internal Medicine III
- ClinicalTrials.gov ID
- NCT04263857
- Acronym / sponsor ID
- REBB3M / REBB3M
- Conditions
- Hematologic Malignancies
- Keywords
- autologous & allogenic blood stem cell transplantations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Nov 2037 (estimated)
- Study completion
- Nov 2037 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Register of patients with blood stem cell transplantations (autologous, allogen).
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all adults, Age >= 18 years
Key inclusion criteria (2 listed)
- signed IC
- patients eligible for stem cell transplantation
Key exclusion criteria (1 listed)
- unable to consent to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Register of stem cell transplantation
Time frame: approximately over 20 years
Recording of all stem cell transplantations over many years
4 secondary outcomes
Register of toxicities
Time frame: approximately over 20 years
Register of complications
Time frame: approximately over 20 years
Register of morbidities
Time frame: approximately over 20 years
Register of survivals
Time frame: approximately over 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mareike Verbeek, MD principal investigator
Klinikum rechts der Isar der TU Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancies, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mareike Verbeek, MD (+49 89 4140 ext. 5336, mareike.verbeek@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Register of stem cell transplantation (time frame: approximately over 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.