A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosis

NCT05020652 | Active Not Recruiting Phase 2

• 1 other identifier: TQ05105-II-01
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 4

Brief Summary

Q05105 tablet is a Janus kinase 2 (JAK2) inhibitor, which can be used to treat JAK2 target related diseases, such as moderate or high-risk multiple myelofibrosis

Conditions

Moderate and High Risk Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• Spleen Volume was Reduced by more than 35% from baseline（SVR35） assessed by Independent Review Committee (IRC)

  Proportion of subjects whose spleen volume was reduced by more than 35% from baseline at the end of week 24 of IRC assessment (SVR35)

  up to 24 weeks

Secondary Outcomes (10)

• SVR35 assessed by the researchers and objective response rate (ORR)

  up to 24 weeks

• optimal response rate of splenic response

  up to 120 weeks

• onset time of splenic response

  up to 120 weeks

• Duration of Maintenance of a Least 35% Reduction in Spleen Volume(DoMSR)

  up to 120 weeks

• the proportion of subjects whose total symptom score of Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score(MPN-SAF TSS) decreased by more than 50% compared with baseline

  up to 24 weeks

Study Arms (2)

TQ05105 tablets + Hydroxyurea blank tablets

EXPERIMENTAL

Take TQ05105 Tablets + Hydroxyurea blank tablets orally on an empty stomach, with an interval of at least 8 hours, and the best interval is 12 hours. Every 4 weeks is a period of administration

Drug: TQ05105 tablets

TQ05105 blank tablets + Hydroxyurea tablets

ACTIVE COMPARATOR

Take TQ05105 blank tablets + Hydroxyurea tablets orally on an empty stomach, with an interval of at least 8 hours, and the best interval is 12 hours. Every 4 weeks is a period of administration

Drug: Hydroxycarbamide tablets

Interventions

TQ05105 tablets DRUG

TQ05105 tablet is a JAK2 inhibitor, which can be used to treat JAK2 target related diseases, such as moderate or high-risk multiple myelofibrosis.

TQ05105 tablets + Hydroxyurea blank tablets

Hydroxycarbamide tablets DRUG

Hydroxycarbamide tablet is a nucleoside diphosphate reductase inhibitor.

TQ05105 blank tablets + Hydroxyurea tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects volunteered to join the study and signed informed consent, with good compliance;
• Age: 18-75 years old (when signing the informed consent form); Eastern Cooperative oncology Group (ECoG) Performance Status (PS) score: 0-2; The expected survival time is more than 24 weeks;
• Primary Myelofibrosis (PMF) was diagnosed according to World Health Organization (WHO) standard (2016 Edition), or Post Polycythemia Vera(PV)-MF or Post Essential Thrombocythemia (ET)-MF was diagnosed according to International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) standard; JAK2 mutation or not was included in the study;
• According to Dynamic International Prognostic Scoring System (DIPSS) prognosis grading criteria, the patients with myelofibrosis were assessed as medium risk (including medium risk-1, medium risk-2) or high risk;
• Splenomegaly: palpate the splenic margin at least 5cm below the ribs (the distance from the costal margin to the farthest point of splenic protrusion);
• Peripheral blood primordial cells ≤ 10%;
• If antifibrotic treatment for myelofibrosis is ongoing before screening, hydroxyurea, any immunomodulators such as thalidomide, short-acting interferons, androgenic drugs, and any immunosuppressants (such as prednisone \> 10mg/day or equivalent strength corticosteroids) must be discontinued for at least 2 weeks before randomization; long-acting interferons and erythropoietin must be discontinued for at least 4 weeks before randomization;
• No growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and hemoglobin (Hgb) ≥ 80g / L, platelet count (PLT) ≥ 100 within 7 days before the random date × 10\^9 / L and neutrophil absolute value (neut) ≥ 1.0 × 10\^9/L;
• The main organs were functional 7 days before the random date, which was in accordance with the following criteria: Total Bilirubin (TBIL) was less than 2 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) were less than 2.5 times of ULN; Serum creatinine (Cr) \< 1.5 times of ULN or creatinine clearance rate (Ccr) ≥ 50ml/min; The blood coagulation function should be checked in accordance with: prothrombin time (PT), activated partial thromboplastin time (APTT), international standardized ratio (INR) \< 1.5 × ULN (not anticoagulant treatment); Left ventricular ejection fraction (LVEF) evaluated by color Doppler ultrasonography ≥ 50%;
• Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; The serum pregnancy test was negative within 7 days before the date of randomization and must be non lactating subjects; Male subjects should agree to use contraception during the study period and within 6 months after the end of the study period.

You may not qualify if:

• Those who have received allogeneic stem cell transplantation in the past, or autologous stem cell transplantation within 3 months before the random date, or recently planned stem cell transplantation;
• Patients who have received JAK inhibitors in the past;
• Those who had undergone splenectomy or received splenic radiotherapy within 6 months before the date of randomization (including internal and external radiotherapy);
• Other malignancies were present or present within 3 years before the date of randomization. The following two cases can be included: other malignant tumors treated by single operation have achieved 5-year disease-free survival (DFS) in a row; Cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non-invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
• Patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.) affecting oral or absorption of drugs;
• Non hematological toxicity caused by previous treatment did not return to ≤ 1 (excluding alopecia);
• Patients who received major surgical treatment or had obvious traumatic injury within 4 weeks before the date of randomization;
• At present, there are congenital bleeding or coagulation diseases, or are using anticoagulant therapy;
• Arteriovenous thrombotic events occurred within 6 months before the random date, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
• A history of psychotropic substance abuse or mental disorder;
• Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events(CTCAE)2 infection);
• Hepatitis B Virus (HBV) DNA≥ULN； Hepatitis C antibody positive and Hepatitis C Virus (HCV) RNA ≥ ULN;
• Myocardial ischemia or myocardial infarction, arrhythmia, QT interval prolongation (corrected QT interval (QTc) ≥ 450 ms for male, QTc ≥ 470 ms for female) and congestive heart failure (NYHA classification) of grade 2 or above;
• Blood pressure control is not ideal (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
• Renal failure requires hemodialysis or peritoneal dialysis;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (4)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

Location

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, 510055, China

Location

West China School of Medicine / West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Institute of Hematology & Blood Diseases Hostpital, Chinese Academy of medical sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 25, 2021
• Study Start: November 11, 2021
• Primary Completion: October 15, 2023
• Study Completion: February 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CN (4)