Hetrombopag for the Enhancement of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This investigator-initiated, prospective, multicenter, open-label, randomized, controlled clinical study is designed to evaluate the clinical efficacy and safety of hetrombopag for promoting platelet engraftment after allo-HSCT in patients with hematological disease.

After signing the informed consent form, the patients will enter the screening period (up to 14 days), and the qualified patients will be randomly selected into the experimental group and the control group according to the ratio of 1:1.

Experimental group: After hematopoietic stem cell reinfusion, the patients begin to take hetrombopag orally 7.5mg/d, until the patients reach complete platelet response (CR, platelet count ≥ 50×109/L for 3 consecutive days without platelet transfusions for 7 consecutive days). The treatment will stop when patients accept 21 consecutive days of treatment or reach the discontinuation criteria.

Control group: After hematopoietic stem cell transfusion, the patients will be only observed, and the observation during the treatment period will be ended after 30 days.

Patients will continue to enter the follow-up period (+ 100 days after transplantation) and the survival follow-up period (1 year after transplantation) after the end of the treatment period.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital

Criteria

Inclusion Criteria:

1. The patients signed the informed consent and participated in the study voluntarily;

2. Age ≥ 18 years old, regardless of gender;

3. ECOG score ≤ 2;

4. Expected survival ≥ 3 months;

5. Patients with hematological diseases who received allo-HSCT for the first time;

6. The patient's laboratory tests met the following criteria:

1. Alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN), Aspartate aminotransferase (AST) ≤ 3.0 × ULN;

2. Serum total bilirubin ≤ 1.5 × ULN;

3. Serum creatinine ≤ 1.5 × ULN;

7. Investigators evaluated that patients would benefit from hetrombopag.

Exclusion Criteria:

1. History of allergy to TPO-RA drugs;

2. Previous bone marrow or hematopoietic stem cell transplantation;

3. Hematologic malignancies did not reach complete remission before transplantation;

4. Central nervous system leukemia;

5. Arterial or venous thrombosis, such as cerebral infarction, pulmonary embolism, arterial thrombosis, deep venous thrombosis and disseminated intravascular coagulation (DIC), occurred within 6 months before the screening period;

6. Heart disease, such as New York Heart Association (NYHA) class III/IV congestive heart failure, angina pectoris, myocardial infarction, and arrhythmias requiring treatment, occurring within 6 months before the screening period;

7. Prolonged QT syndrome during the screening period;

8. Active hepatitis B or hepatitis C;

9. Positive for anti-HIV antibodies or anti-TP antibodies;

10. Active infection that is difficult to control;

11. Pregnant or breastfeeding women;

12. Other conditions not suitable for inclusion evaluated by the investigator.