Clinical trial · Interventional
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia
A Randomized, Controlled Study on the Efficacy and Safety of Hetrombopag in the Treatment of Chemotherapy-induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia
NCT05944211CI-TRIAL-00067989H-CIT-AMLnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hetrombopag Olamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hetrombopag
- description
- The study in a 1:1 randomization ratio (36 subjects to experimental group). The treatment group received Herteppa Ethanolamine tablets and platelet transfusion.
- interventionNames
- Drug: Hetrombopag Olamine
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
Primary outcomes (1)
- measure
- Days that platelet count firstly rebound to 100×109/L
- timeFrame
- Randomization up to 28 days
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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; Exclusion Criteria: * 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;
References
Publications (0)
Data not yet available
No reference posted for this study.