Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia

NCT05944211 | Not Yet Recruiting Phase 2

• 1 other identifier: 22-OBU-SH-CIT-II-001
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized, controlled, open study to evaluate the efficacy and safety of Hetrombopag in the treatment of chemotherapy-induced thrombocytopenia(CIT) in patients with acute myeloid leukemia

Conditions

Chemotherapy-Induced Thrombocytopenia

Keywords

Chemotherapy-Induced Thrombocytopenia; Acute Myeloid Leukemia; Hetrombopag

Outcome Measures

Primary Outcomes (1)

• Days that platelet count firstly rebound to 100×109/L

  Randomization up to 28 days

Secondary Outcomes (6)

• Days that platelet count firstly rebound to 50×109/L

  Randomization up to 28 days

• The median dose and duration of hetrombopag from starting treatment to platelet count ≥100×109/L

  Randomization up to 28 days

• The minimum platelet count at the chemotherapy cycle

  Randomization up to 28 days

• The lasting days of platelet count below 50×109/L at the chemotherapy cycle

  Randomization up to 28 days

• The lasting days of platelet count below 25×109/L at the chemotherapy cycle

  Randomization up to 28 days

Study Arms (2)

Hetrombopag

EXPERIMENTAL

The study in a 1:1 randomization ratio (36 subjects to experimental group). The treatment group received Herteppa Ethanolamine tablets and platelet transfusion.

Drug: Hetrombopag Olamine

Control

NO INTERVENTION

The study in a 1:1 randomization ratio (36 subjects to control group). The control group did not receive other platelet raising therapy except platelet transfusion.

Interventions

Hetrombopag Olamine DRUG

The subjects will initiate treatment with 7.5 mg hetrombopag once a day, starting orally 24 hours after the end of chemotherapy. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts once every two weeks, and maximum dose should not exceed 15 mg daily. Subjects whose platelet count \<25×109/L for 2 weeks, the hetrombopag dose will be increased by 2.5mg. If subjects whose platelet count ≥100×109/L or who had received hetrombopag for 28 days, hetrombopag can be stopped. Hetrombopag Olamine is sponsored by Jiangsu Hengrui Pharmaceuticals Co., Ltd. Emergency treatment: When the platelet count was less than 20×109/L, platelet transfusion was given according to the evaluation of the investigator.

Hetrombopag

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-70;
• Participant with a histologically or cytologically confirmed acute myeloid leukemia in complete remission (PLT≥100×109/L) (except acute promyelocytic leukemia);
• Participant who have completed induction therapy and achieved complete remission, have received ≤1 course of intensive consolidation chemotherapy, and will continue to receive intensive consolidation or maintenance chemotherapy;
• Intensive chemotherapy after complete remission including: high-dose or medium-dose cytarabine chemotherapy (1-1.5g/m2 q12h×3 days), standard-dose chemotherapy (cytarabine combined with anthracycline/anthraquinones, HHT, pohyllotoxin, etc.);
• Participant whose Expected survival time ≥3 months, and who can receive at least 2 cycles of intensive chemotherapy;
• ECOG performance status \<=2;
• Participants of childbearing age who agree to use reliable contraceptive methods;
• Patients signed the informed consent form and volunteered to participate in this study with good compliance;

You may not qualify if:

• Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
• Participant has a history of arterial or venous thrombosis within 6 months before screening (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or has clinical symptoms and medical history suggestive of thrombophilia;
• Participant has a history of severe cardiovascular disease within 6 months before screening, such as congestive heart failure (NYHA class III-IV), arrhythmia known to increase the risk of thromboembolism (atrial fibrillation), post-coronary stent implantation, angioplasty, or coronary artery bypass grafting;
• Known human immunodeficiency virus infection,or hepatitis C infection (if hepatitis B surface antigen is positive, or hepatitis B surface antigen is negative but hepatitis B core antibody is positive, HBV-DNA testing is required, if virus replication is suggested, the subject should be excluded);
• Abnormal liver function (TBL\>3xULN; alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]\>3xULN);
• Abnormal renal function with serum creatinine\>1.5xULN or creatinine clearance ≤ 60 ml/min using Cockcroft-Gault estimated creatinine clearance;
• Pregnant or lactating women, or those planning to receive/give birth in the near 6 months;
• Participant participated in other clinical trials within 3 months before enrollment;
• Previous use of thrombopoietin receptor agonist (TPO-RA), recombinant human TPO, recombinant human interleukin-11(rhlL-11) within 1 month before screening;
• Received platelet transfusions within 3 days before enrollment;
• Patients with known or expected allergy or intolerance to the active ingredient or excipients of hetrombopag;
• Inability to understand the nature of the study or failure to obtain informed consent;
• The investigator considers that there are any other conditions that may prevent the subject from completing the study or present a significant risk to the subject;

Sponsors & Collaborators

• RenJi Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Xiaofeng Han, MD.,Ph.D

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Yi Fang, MD.,Ph.D

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Fang, MD.,Ph.D

CONTACT

86-21-68383144; fangyi@renji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 13, 2023

Record last verified: 2023-07