TerminatedPhase 2

RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation

Stopped: inclusions difficulties.

France9 participantsStarted 2019-09-05

Plain-language 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

Who can participate

Age range6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 are performed, * Affiliation to a social security system. Exclusion Criteria: * Criteria for poor graft function not fulfilled (see above), * Patients aged less than 6 years old (or unable to swallow), * Hepatic impairment (Child-Pugh ≥ 5), * Patients with bone morrow fibrosis, * 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…

What they're measuring

Platelet response

Timeframe: at 12 weeks

Trial details

NCT IDNCT03948529

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-24