RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation (REGALIA)

  • End date
    Dec 20, 2023
  • participants needed
  • sponsor
    University Hospital, Lille
Updated on 4 October 2022
graft versus host disease
cell transplantation


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

Condition Leukemia, Graft Failure
Treatment Eltrombopag
Clinical Study IdentifierNCT03948529
SponsorUniversity Hospital, Lille
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Diagnosis of poor graft function defined as
Patient ≥ day+60 after allo-HCT
Persisting thrombocytopenia on two different samples over at least two weeks (platelet < 30G/L with transfusion requirement) +/- neutropenia (ANC <1G/L) +/- anemia (Hb <8g/dL or transfusion requirement)
Full donor chimerism on whole blood (≥ 95%)
Biopsy proven hypocellular marrow without evidence of myelodysplasia
No evidence for relapse
No evidence for active acute or chronic graft versus host disease
Absence of active viral infection (EBV, CMV, ADENOVIRUS, PARVOVIRUS B19)
Absence of B9/B12 deficiency
Absence of hypothyroidism
Absence of hypogonadism
Absence of dialysis
Absence of thrombotic microangiopathy
Absence of macrophage activation syndrome
No other known causes of poor graft function
Written informed consent must be obtained before any study-trial specific procedure
Affiliation to a social security system
are performed

Exclusion Criteria

Criteria for poor graft function not fulfilled (see above)
Patients aged less than 6 years old (or unable to swallow)
Patients with bone morrow fibrosis
Hepatic impairment (Child-Pugh ≥ 5)
Patients with a cytogenetic abnormality of chromosome 7
Hypersensitivity to eltrombopag or to any of the excipients
Patients with any contra-indication to eltrombopag, filgrastim
Unable to understand the investigational nature of the study or give informed consent
History of congestive heart failure, arrhythmia requiring chronic treatment, arterial or venous
Thrombosis (not excluding line thrombosis) within the last 1 year, or myocardial infarction within 3 months before enrollment
ECOG Performance Status of 3 or greater
Pregnant and/or lactating women
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