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

STATUS

Recruiting
End date

Dec 20, 2023
participants needed

25
sponsor

University Hospital, Lille

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Updated on 4 October 2022

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graft versus host disease

anemia

myelodysplasia

cell transplantation

thrombocytopenia

Summary

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

Details

Condition	Leukemia, Graft Failure
Treatment	Eltrombopag
Clinical Study Identifier	NCT03948529
Sponsor	University Hospital, Lille
Last Modified on	4 October 2022

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Eligibility		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
	Freedom privacy

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