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NCT04469985

Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey

Completed Last updated 22 July 2021
What this trial tests

trial in Allogeneic Stem Cell Transplantation in Elderly Patients in 2,061 participants. Completed in 31 December 2020.

Timeline
1 February 2020
Primary endpoint
31 December 2020
31 December 2020

Quick facts

Lead sponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
StatusCompleted
Study typeOBSERVATIONAL
Enrollment2,061
Start date1 February 2020
Primary completion31 December 2020
Estimated completion31 December 2020
Sites1 location across Italy

Conditions studied

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — full company profile →

Who can join

60 and older, any sex, with Allogeneic Stem Cell Transplantation in Elderly Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The age of patients' population is increasing every year, as the life expectancy. Thus, the incidence and prevalence of hematological cancers is increasing. In particular, acute leukemias and myelodisplastic syndromes are the most frequent diseases of the hematopoietic system. Allogeneic stem cell transplantation (allo-SCT) is the main therapeutic options for these diseases, and the number of allo-SCTs in the elderly is currently in progressive growth. This is partially due to the improvement of the allo-SCT procedure over the years, with the amelioration of donor selection, HLA typing, graft versus host disease (GVHD) and infections prophylaxis and treatment. Nevertheless, there is still an unmet clinical need, represented by the lack of extensively and detailed outcome analysis of elderly patients addressed to allo-SCT. With this aim, we planned this retrospective analysis of allo-SCTs in patients older than 60 years, within the GITMO transplant activity of the last 17 years. This study will help us in designing future prospective trials, including a comprehensive geriatric assessment of frailty, in order to address to allo-SCT those elderly who have the highest probability to achieve the best long term outcome with the lowest transplant-related mortality and morbidity.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. GITMO Registry Study on Allogeneic Transplantation in Patients Aged ≥60 Years from 2000 to 2017: Improvements and Criticisms.
    Malagola M, Polverelli N, Rubini V, Martino M, et al · · 2022 · cited 26× · PMID 34818581 · DOI 10.1016/j.jtct.2021.11.006
  2. Busulfan or Treosulfan Conditioning Platform for Allogeneic Stem Cell Transplantation in Patients Aged >60 Y With Acute Myeloid Leukemia/Myelodysplastic Syndrome: A Subanalysis of the GITMO AlloEld Study.
    Malagola M, Polverelli N, Martino M, Patriarca F, et al · · 2023 · cited 10× · PMID 36845852 · DOI 10.1097/txd.0000000000001451
  3. Donor-specific anti-HLA antibodies (DSAs) in patients undergoing allogeneic hematopoietic stem cell transplantation from mismatched donors on behalf of GITMO and AIBT.
    La Rocca U, Ricci R, Piciocchi A, Barberi W, et al · · 2025 · PMID 39949023 · DOI 10.2450/bloodtransfus.790

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Other Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia trials

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