Secondary Haplo HSCT for Relapse After Initial Allogeneic HSCT

NCT01997918 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2018-05-03

No results posted yet for this study

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. 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.

Conditions

  • Relapse of Hematological Malignancies

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER
  • University Hospital Augsburg

    collaborator OTHER
  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Wolfgang A Bethge, MD · University Hospital Tuebingen

  • Christoph Schmid, MD · University Hospital Augsburg

  • Johanna Tischer, MD · Ludwig-Maximilians University Hospital Munich

  • Maximilian Christopeit, MD · University Hospital of Halle

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-12-30
Completion
2017-12-30

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View NCT01997918 on ClinicalTrials.gov