Does Eltrombopag Improve Blood Cell Recovery in Leukemia Patients After Transplant?

Efficacy of Prophylactic Oral Eltrombopag for Promoting Platelet and Neutrophil Engraftment After Haploidentical Hematopoietic Stem Cell Transplantation in Patients with acute lymphoblastic leukemia: A Phase II Non Randomized-controlled Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N51

Enrollment

Registered

2025-12-12

Start date

2025-10-23

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymphoblastic leukemia [ALL]. Acute lymphoblastic leukemia [ALL]

Interventions

Intervention 1: Intervention group: Patient with acute leukemia and recipient of haploidentical transplant will receive oral Eltrombopag, which is a thrombopoietin receptor agonist and will be used t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Definitive diagnosis of acute lymphocytic leukemia Medical indication of Haploidentical Hematopoietic Stem Cell Transplantation The patient must be in Complete Remission before the transplant

Exclusion criteria

Exclusion criteria: Patients with abnormal liver function tests such as alanine aminotransferase greater equal than 2.5 times the upper limit of normal or bilirubin greater than1 mg/dL will not enter the study.

Design outcomes

Primary

Measure	Time frame
Platelet engraftment (when the patient is independent of platelet transfusion for at least 7 days with a platelet count >20 × 10?/L). Timepoint: Daily measurements, from the start of the intervention and at least until 10 days after the intervention. Method of measurement: According to the complete blood count (CBC) laboratory test performed using an automated cell counter.;Neutrophil engraftment (when the absolute neutrophil count consistently exceeds 0.5 × (10)9/L for 3 days in a row without a growth factor support.). Timepoint: Daily measurements, from the start of the intervention and at least until 10 days after the intervention. Method of measurement: According to the complete blood count (CBC) laboratory test performed using an automated cell counter.;The occurrence of Graft versus Host disease according to the MAGIC criteria. Timepoint: Daily assessments , from 5 days before the start of the intervention (from the day of transplantation) and until 3 months after the intervention. Method of measurement: In accordance with the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria.;Overall survival. Timepoint: Patients will be followed from 5 days before the start of the intervention daily during hospitalization and then monthly after discharge and until 2 years after the intervention. Method of measurement: Survival data will be collected using a checklist that includes survival status and time of assessment by trained personnel during hospitalization in the ward and during post-discharge follow-ups.;Relapse. Timepoint: Patients will be followed from 5 days before the start of the intervention daily during hospitalization and then monthly after discharge and until 2 years after the intervention. Method of measurement: Relapse data will be collected using a checklist that includes relapse status and time of assessment by trained personnel during hospitalization in the ward and during post-discharge follow-ups according to patients clinical records.	—

Measure

Time frame

Platelet engraftment (when the patient is independent of platelet transfusion for at least 7 days with a platelet count >20 × 10?/L). Timepoint: Daily measurements, from the start of the intervention and at least until 10 days after the intervention. Method of measurement: According to the complete blood count (CBC) laboratory test performed using an automated cell counter.;Neutrophil engraftment (when the absolute neutrophil count consistently exceeds 0.5 × (10)9/L for 3 days in a row without a growth factor support.). Timepoint: Daily measurements, from the start of the intervention and at least until 10 days after the intervention. Method of measurement: According to the complete blood count (CBC) laboratory test performed using an automated cell counter.;The occurrence of Graft versus Host disease according to the MAGIC criteria. Timepoint: Daily assessments , from 5 days before the start of the intervention (from the day of transplantation) and until 3 months after the intervention. Method of measurement: In accordance with the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria.;Overall survival. Timepoint: Patients will be followed from 5 days before the start of the intervention daily during hospitalization and then monthly after discharge and until 2 years after the intervention. Method of measurement: Survival data will be collected using a checklist that includes survival status and time of assessment by trained personnel during hospitalization in the ward and during post-discharge follow-ups.;Relapse. Timepoint: Patients will be followed from 5 days before the start of the intervention daily during hospitalization and then monthly after discharge and until 2 years after the intervention. Method of measurement: Relapse data will be collected using a checklist that includes relapse status and time of assessment by trained personnel during hospitalization in the ward and during post-discharge follow-ups according to patients clinical records.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTahereh Rostami

Tehran University of Medical Sciences

tah.rostami94@gmail.com+98 21 8490 2635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026