Clinical trial · Observational
Secondary Haplo HSCT for Relapse After Initial Allogeneic HSCT
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapse of Hematological Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Treatment related mortality (TRM) of haploidentical HSCT2
- timeFrame
- up to day 365
- measure
- Toxicity of haploidentical HSCT2
- timeFrame
- up to day 365
- description
- NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4
Secondary outcomes (5)
- measure
- complete remission (CR) rate after haploidentical HSCT2
- timeFrame
- day 100
- measure
- Overall survival (OS) at 2 years after haploidentical HSCT2
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available