MedTrace Logo

RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation

NCT03948529 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-09-30

No results posted yet for this study

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

Conditions

Interventions

DRUG

eltrombopag

eltrombopag at the starting dose of 50mg/day. After 2 weeks of eltrombopag initiation and in the absence of platelet response, eltrombopag will be increased every two weeks (50mg increase) up to a maximum dose of 150mg/day (2 maximum escalation from D1, with maximum dose escalation phase of 4 weeks).

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Ibrahim Yakoub-Agha, MD,PhD · University Hospital, Lille

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2023-02-24
Completion
2023-08-21

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03948529 on ClinicalTrials.gov