Relapse of Hematological MalignanciesNCT01997918
Secondary Haplo HSCT for Relapse After Initial Allogeneic HSCT
An observational study of Relapse of Hematological Malignancies, run by University Hospital Tuebingen.
Trial summary
Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2). Choosing an alternative donor is often advocated to maximize chances of a graft versus tumour (GVT) effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapse of Hematological Malignancies
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to 30 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients receiving salvage secondary haploidentical allogeneic HSCT after failure of primary allogeneic HSCT
Who may be able to join
- Age >18 years at time of HSCT2
- Malignant hematologic disease
- Informed consent signed by the patients on the use of data in registry analyses
- 1st allogeneic HSCT performed from any donor, including haploidentical HSCT1
- Hematological or extramedullary relapse after HSCT1
- Haploidentical 2nd allogeneic HSCT (i.e. >= 2 Antigen mismatch family donor) between 01.07.2003 and 30.06.2013
- Third or higher allogeneic HSCT does not preclude analysis as long as HSCT2 was haploidentical.
Who cannot join
None listed.
About this study
Official title: Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in the Treatment of Relapse After a First Allogeneic HSCT: a Retrospective Cohort Study by the German Cooperative Transplant Study Group
Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2). Choosing an alternative donor is often advocated to maximize chances of a graft versus tumour (GVT) effect. We and others published that success of this strategy when using an alternative human leukocyte antigen (HLA) identical donor is limited, at least when acute leukemia is the underlying disease. The aggressivity of the rapidly proliferating leukemia seems to prevail over GVT effects. A more potent alloimmune response is observed following haploidentical HSCT, especially early after haploidentical HSCT. This might be related to a fast and large expansion of natural killer (NK)-cells. Their alloreactive effect might translate into higher rates of tumor control. On the other hand, non-relapse complications (treatment related mortality, TRM) might be high in advanced relapsed tumour patients with heavy pretreatment and due to delayed immune reconstitution after haploidentical HSCT. The use of a haploidentical donor for HSCT2 following a first allogeneic HSCT from an HLA identical donor has been so far only systematically evaluated in small retrospective single center reports. Thus, in this multicenter study we aim to collect data on the extent to which participating centers employ haploidentical transplantation in the situation of relapse after HSCT2.
Read the detailed description
Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2). Choosing an alternative donor is often advocated to maximize chances of a graft versus tumour (GVT) effect. We and others published that success of this strategy when using an alternative HLA identical donor is limited, at least when acute leukemia is the underlying disease. The aggressivity of the rapidly proliferating leukemia seems to prevail over GVT effects. A more potent alloimmune response is observed following haploidentical HSCT, especially early after haploidentical HSCT. This might be related to a fast and large expansion of NK-cells. Their alloreactive effect might translate into higher rates of tumor control. On the other hand, non-relapse complications (treatment related mortality, TRM) might be high in advanced relapsed tumour patients with heavy pretreatment and due to delayed immune reconstitution after haploidentical HSCT. The use of a haploidentical donor for HSCT2 following a first allogeneic HSCT from an HLA identical donor has been so far only systematically evaluated in small retrospective single center reports. Thus, in this multicenter study we aim to collect data on the extent to which participating centers employ haploidentical transplantation in the situation of relapse after HSCT2. We will describe and quantify the specific patient, donor, treatment, graft and outcomes characteristics associated with the course of treatment. To assess and control for the bias that is associated with the retrospective nature of this study, we will emphasize to collect clearly stated reasons for the decision to use a haploidentical transplant, e.g. as opposed to drug therapy or a second transplant from the original or an alternative HLA identical donor. This is a retrospective observational cohort study. German centers performing allogeneic HSCT are asked to contribute. Data will be validated and missing information will be further retrieved by the four principal investigators through phone. Final follow up will be performed in April 2014, 2014. To be able to supply durable data on the primary endpoints, only patients receiving a haploidentical HSCT2 between 01.07.2003 and 30.06.2013 will be included.
- Conditions
- Relapse of Hematological Malignancies
- Keywords
- Secondary allogeneic HSCT, Haploidentical HSCT
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related mortality (TRM) of haploidentical HSCT2
Measured: up to day 365
Toxicity of haploidentical HSCT2
NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4
Measured: up to day 365
Secondary outcomes (5)
complete remission (CR) rate after haploidentical HSCT2
Measured: day 100
Overall survival (OS) at 2 years after haploidentical HSCT2
Measured: 2 years
Graft versus host disease (GVHD) after haploidentical HSCT2
Measured: 2 years
Incidence of rejection after haploidentical HSCT2
Measured: 1 year
Disease free survival (DFS) at 2 years after haploidentical HSCT2
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse of Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Hospital Augsburg
- Responsible party
- Sponsor
- Investigators
- Wolfgang A Bethge, MD, Principal investigator, University Hospital TuebingenChristoph Schmid, MD, Principal investigator, University Hospital AugsburgJohanna Tischer, MD, Principal investigator, Ludwig-Maximilians University Hospital MunichMaximilian Christopeit, MD, Principal investigator, University Hospital of Halle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997918
- Sponsor's protocol ID
- KTS 2. Haplo HSCT
- Status last verified
- May 2018
- First submitted
- 29 Oct 2013
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in the Treatment of Relapse After a First Allogeneic HSCT: a Retrospective Cohort Study by the German Cooperative Transplant Study Group
- ClinicalTrials.gov ID
- NCT01997918
- Acronym / sponsor ID
- KTS 2. Haplo HSCT
- Conditions
- Relapse of Hematological Malignancies
- Keywords
- Secondary allogeneic HSCT, Haploidentical HSCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Hospital Augsburg
- Study start
- Oct 2013 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 28 Nov 2013 (estimated)
- 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.
Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2). Choosing an alternative donor is often advocated to maximize chances of a graft versus tumour (GVT) effect. We and others published that success of this strategy when using an alternative human leukocyte antigen (HLA) identical donor is limited, at least when acute leukemia is the underlying disease. The aggressivity of the rapidly proliferating leukemia seems to prevail over GVT effects. A more potent alloimmune response is observed following haploidentical HSCT, especially early after haploidentical HSCT. This might be related to a fast and large expansion of natural killer (NK)-cells. Their alloreactive effect might translate into higher rates of tumor control. On the other hand, non-relapse complications (treatment related mortality, TRM) might be high in advanced relapsed tumour patients with heavy pretreatment and due to delayed immune reconstitution after haploidentical HSCT. The use of a haploidentical donor for HSCT2 following a first allogeneic HSCT from an HLA identical donor has been so far only systematically evaluated in small retrospective single center reports. Thus, in this multicenter study we aim to collect data on the extent to which participating centers employ haploidentical transplantation in the situation of relapse after HSCT2.
Detailed description
Relapse of underlying hematologic malignancies after allogeneic hematopoietic stem cell transplantation (HSCT) is frequently treated by a second allogeneic HSCT (HSCT2). Choosing an alternative donor is often advocated to maximize chances of a graft versus tumour (GVT) effect. We and others published that success of this strategy when using an alternative HLA identical donor is limited, at least when acute leukemia is the underlying disease. The aggressivity of the rapidly proliferating leukemia seems to prevail over GVT effects. A more potent alloimmune response is observed following haploidentical HSCT, especially early after haploidentical HSCT. This might be related to a fast and large expansion of NK-cells. Their alloreactive effect might translate into higher rates of tumor control. On the other hand, non-relapse complications (treatment related mortality, TRM) might be high in advanced relapsed tumour patients with heavy pretreatment and due to delayed immune reconstitution after haploidentical HSCT. The use of a haploidentical donor for HSCT2 following a first allogeneic HSCT from an HLA identical donor has been so far only systematically evaluated in small retrospective single center reports. Thus, in this multicenter study we aim to collect data on the extent to which participating centers employ haploidentical transplantation in the situation of relapse after HSCT2. We will describe and quantify the specific patient, donor, treatment, graft and outcomes characteristics associated with the course of treatment. To assess and control for the bias that is associated with the retrospective nature of this study, we will emphasize to collect clearly stated reasons for the decision to use a haploidentical transplant, e.g. as opposed to drug therapy or a second transplant from the original or an alternative HLA identical donor. This is a retrospective observational cohort study. German centers performing allogeneic HSCT are asked to contribute. Data will be validated and missing information will be further retrieved by the four principal investigators through phone. Final follow up will be performed in April 2014, 2014. To be able to supply durable data on the primary endpoints, only patients receiving a haploidentical HSCT2 between 01.07.2003 and 30.06.2013 will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving salvage secondary haploidentical allogeneic HSCT after failure of primary allogeneic HSCT
Key inclusion criteria (7 listed)
- Age >18 years at time of HSCT2
- Malignant hematologic disease
- Informed consent signed by the patients on the use of data in registry analyses
- 1st allogeneic HSCT performed from any donor, including haploidentical HSCT1
- Hematological or extramedullary relapse after HSCT1
Key exclusion criteria (0 listed)
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
Treatment related mortality (TRM) of haploidentical HSCT2
Time frame: up to day 365
Toxicity of haploidentical HSCT2
Time frame: up to day 365
NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4
5 secondary outcomes
complete remission (CR) rate after haploidentical HSCT2
Time frame: day 100
Overall survival (OS) at 2 years after haploidentical HSCT2
Time frame: 2 years
Graft versus host disease (GVHD) after haploidentical HSCT2
Time frame: 2 years
Incidence of rejection after haploidentical HSCT2
Time frame: 1 year
Disease free survival (DFS) at 2 years after haploidentical HSCT2
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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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. This study is not recruiting at the moment.
Wolfgang A Bethge, MD principal investigator
University Hospital Tuebingen
Christoph Schmid, MD principal investigator
University Hospital Augsburg
Johanna Tischer, MD principal investigator
Ludwig-Maximilians University Hospital Munich
Questions about this trial
What is this clinical trial studying?
An observational study of Relapse of Hematological Malignancies, run by University Hospital Tuebingen.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related mortality (TRM) of haploidentical HSCT2 (time frame: up to day 365). The study lists 2 primary outcomes in all. 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 3 May 2018.