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Secondary Haplo HSCT for Relapse After Initial Allogeneic HSCT
2 mei 2018 bijgewerkt door: University Hospital Tuebingen
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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
60
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Patients receiving salvage secondary haploidentical allogeneic HSCT after failure of primary allogeneic HSCT
Beschrijving
Inclusion Criteria:
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Treatment related mortality (TRM) of haploidentical HSCT2
Tijdsspanne: up to day 365
|
up to day 365
|
|
|
Toxicity of haploidentical HSCT2
Tijdsspanne: up to day 365
|
NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4
|
up to day 365
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
complete remission (CR) rate after haploidentical HSCT2
Tijdsspanne: day 100
|
day 100
|
|
Overall survival (OS) at 2 years after haploidentical HSCT2
Tijdsspanne: 2 years
|
2 years
|
|
Graft versus host disease (GVHD) after haploidentical HSCT2
Tijdsspanne: 2 years
|
2 years
|
|
Incidence of rejection after haploidentical HSCT2
Tijdsspanne: 1 year
|
1 year
|
|
Disease free survival (DFS) at 2 years after haploidentical HSCT2
Tijdsspanne: 2 years
|
2 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Wolfgang A Bethge, MD, University Hospital Tuebingen
- Hoofdonderzoeker: Christoph Schmid, MD, University Hospital Augsburg
- Hoofdonderzoeker: Johanna Tischer, MD, Ludwig-Maximilians University Hospital Munich
- Hoofdonderzoeker: Maximilian Christopeit, MD, University Hospital of Halle
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 oktober 2013
Primaire voltooiing (Werkelijk)
30 december 2017
Studie voltooiing (Werkelijk)
30 december 2017
Studieregistratiedata
Eerst ingediend
29 oktober 2013
Eerst ingediend dat voldeed aan de QC-criteria
27 november 2013
Eerst geplaatst (Schatting)
28 november 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 mei 2018
Laatste update ingediend die voldeed aan QC-criteria
2 mei 2018
Laatst geverifieerd
1 mei 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KTS 2. Haplo HSCT
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