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- Essai clinique NCT01997918
Secondary Haplo HSCT for Relapse After Initial Allogeneic HSCT
2 mai 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
60
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients receiving salvage secondary haploidentical allogeneic HSCT after failure of primary allogeneic HSCT
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Treatment related mortality (TRM) of haploidentical HSCT2
Délai: up to day 365
|
up to day 365
|
|
|
Toxicity of haploidentical HSCT2
Délai: up to day 365
|
NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4
|
up to day 365
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
complete remission (CR) rate after haploidentical HSCT2
Délai: day 100
|
day 100
|
|
Overall survival (OS) at 2 years after haploidentical HSCT2
Délai: 2 years
|
2 years
|
|
Graft versus host disease (GVHD) after haploidentical HSCT2
Délai: 2 years
|
2 years
|
|
Incidence of rejection after haploidentical HSCT2
Délai: 1 year
|
1 year
|
|
Disease free survival (DFS) at 2 years after haploidentical HSCT2
Délai: 2 years
|
2 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Wolfgang A Bethge, MD, University Hospital Tuebingen
- Chercheur principal: Christoph Schmid, MD, University Hospital Augsburg
- Chercheur principal: Johanna Tischer, MD, Ludwig-Maximilians University Hospital Munich
- Chercheur principal: Maximilian Christopeit, MD, University Hospital of Halle
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 octobre 2013
Achèvement primaire (Réel)
30 décembre 2017
Achèvement de l'étude (Réel)
30 décembre 2017
Dates d'inscription aux études
Première soumission
29 octobre 2013
Première soumission répondant aux critères de contrôle qualité
27 novembre 2013
Première publication (Estimation)
28 novembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 mai 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 mai 2018
Dernière vérification
1 mai 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KTS 2. Haplo HSCT
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .