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NCT03948529: REGALIA

RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation

Terminated Phase 2 Last updated 30 September 2025
What this trial tests

Phase 2 trial testing eltrombopag in Leukemia in 9 participants. Terminated before completion.

Timeline
5 September 2019
Primary endpoint
24 February 2023
21 August 2023

Quick facts

Lead sponsorUniversity Hospital, Lille
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date5 September 2019
Primary completion24 February 2023
Estimated completion21 August 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Lille

Who can join

6 and older, any sex, with Leukemia or Graft Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Poor graft function (PGF) after allogeneic hematopoietic cell transplantation (allo-HCT) is a misunderstood complication associated with poor outcome and limited therapeutic options. Despite the lack of standardized diagnostic criteria, PGF is commonly defined as follows: one or several significant cytopenias after allo-HCT persisting or developing after allo-HCT despite full donor chimerism and in the absence of relapse or other causes. Not only PGF can alter patients' quality of life by leading to recurrent transfusions, bleeding events and infections, but it is also associated with poor survival after allo-HCT. Although PGF is relatively frequent, there is no well-codified behavior in the literature or in the recommendations issued by the various learned societies of transplantation. The aim objective of the investigator's study is to demonstrate that eltrombopag improve PGF after allo-HCT

Publications & conference data

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

  1. Eltrombopag: Role in Cytopenias Following Hematopoietic Stem Cell Transplantation.
    Vasudevan Nampoothiri R, Kumar R. · · 2020 · cited 7× · PMID 32425372 · DOI 10.1007/s12288-019-01194-7
  2. Efficacy and Immunomodulating Properties of Eltrombopag in Aplastic Anemia following Autologous Stem Cell Transplant: Case Report and Review of the Literature.
    Bortolotti M, Pettine L, Zaninoni A, Croci GA, et al · · 2022 · cited 6× · PMID 35455416 · DOI 10.3390/ph15040419
  3. The Development of New Agents for Post-Hematopoietic Stem Cell Transplantation Non-Infectious Complications in Children.
    Ilan U, Brivio E, Algeri M, Balduzzi A, et al · · 2023 · cited 2× · PMID 36983151 · DOI 10.3390/jcm12062149

Verify or expand the search:

Other trials of eltrombopag

Trials testing the same drug.

Other recruiting trials for Leukemia

Currently open trials in the same condition.

Other University Hospital, Lille trials

Trials by the same sponsor.

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Data sources for this page

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