Eltrombopag For Secondary Poor Graft Function Post Allogeneic Hematopoietic Stem Cell Transplantation

NCT03437603 | Unknown Phase 2

• 1 other identifier: Eltrombopag For PGF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the efficacy and safety for secondary poor graft function (PGF) post allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary objective is the hematologic response rate. Secondary objectives include: (1) incidence and severity of adverse events; (2) overall survival (OS), and disease-free survival(DFS).

Conditions

Poor Graft Function

Keywords

Eltrombopag; Allogenetic Hematopoietic Stem Cell Transplantation; Poor Graft Function

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate(Complete Response+Partial Response)

  Complete Response(CR)：CR was defined as neutrophil count ≥ 1.0×109/L independent of G-CSF for 3 consecutive days;platelets count ≥ 50×109/L without the need of platelet transfusion for at least 7 consecutive days;hemoglobin ≥ 90g/L. Partial response (PR)：Patients with at least 2 lines of blood cell count meeting the criteria of hematopoietic engraftment but not that of CR were defined as PR.

  8weeks

Secondary Outcomes (5)

• Overall Survival(OS)/Disease Free Survival(DFS)

  12 months from study entry

• Time to complete response

  8 weeks

• Time to achieve each lineage recovery

  8weeks

• Maintenance time after drug withdrawal

  12 months from study entry

• Incidence of Adverse Events

  12months from study entry

Study Arms (1)

Eltrombopag group

EXPERIMENTAL

Starting dose is 25mg daily for the first 3 days, then increasing to 50mg for another week. Maintenance dosage is 50mg or 75 mg per day dependent on patients' status and doctors' opinion.Planned duration of treatment with eltrombopag is 8 weeks.When patients achieve persistent complete response for 2 weeks,they may stop medicine.

Drug: Eltrombopag

Interventions

Eltrombopag DRUG

Starting Eltrombopag daily on empty stomach (2 hour before breakfast) for 8 weeks.

Also known as: Revolade

Eltrombopag group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients develop poor graft function post allo-HSCT(primary or secondary),who had no response or were transfusion dependent after clinical therapeutic approaches(including growth factors,MSC transfusion,Cluster of differentiation(CD34) positive selected tem cell boosts infusion et al)
• No recurrence or progression of primary malignancy after allo- HSCT
• Patients with full donor chimerism
• Patients without severe GVHD or active infectious diseases, or drug-related myelosuppression;
• Written informed consent obtained from the subject.

You may not qualify if:

• Alanine aminotransferase(ALT)≥2.5 times the upper limit of normal(ULN)
• Serum bilirubin \>2mg/dl
• History of hepatic cirrhosis or the history of portal hypertension
• Patients had any history of arterial / venous thrombosis within 1 year before enrollment in the study.
• Take another treatment for drugs in 30 days or five half-life (no matter which longer) before the first drug delivery.
• Eastern Cooperative Oncology Group(ECOG) performance status≥2.
• Patients with a birth plan within 1 years, the pregnant or lactating women.
• History of heart disease in the last 3 months, including congestive heart failure(III/IV Level, NHYA) ,arrhythmia, or myocardial infarction which medication is necessary. Any arrhythmia which could increase the risk of thrombotic events, or extended QT interval (QTc) of \>480 milliseconds after correction.
• Patients with cataract history；
• Patients with myelofibrosis;
• Patients who are unable to comply in the test and / or follow up stage.
• Any abnormal situation in the screening stage or any other medical history or status that the researchers think is not suitable for the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Interventions

eltrombopag

Study Officials

• Xiaowen Tang, MD

  The First Affliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Tang, MD

CONTACT

8613913538266; tangxiaowen@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Hematology Department，Clinical Professor

Study Record Dates

• First Submitted: January 27, 2018
• First Posted: February 19, 2018
• Study Start: February 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

CN (1)