A Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms

  • STATUS
    Recruiting
  • days left to enroll
    80
  • participants needed
    50
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 24 January 2021
myelofibrosis
leukemia
bone marrow procedure
polycythemia

Summary

TQ05105 is a JAK2 inhibitors and can be used to treat JAK2 target-related diseases. The activation of the JAK/STAT pathway is related to abnormal proliferation, obstruction of apoptosis, and differentiation disorder of leukemia cells which is caused by genetic abnormalities and viral infection.

Details
Condition MYELOPROLIFERATIVE DISORDER, Myeloproliferative Neoplasms, myeloproliferative neoplasm, myeloproliferative disorders
Treatment TQ05105
Clinical Study IdentifierNCT04339400
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Myeloproliferative Neoplasms?
Do you have any of these conditions: MYELOPROLIFERATIVE DISORDER or myeloproliferative neoplasm or myeloproliferative disorders or Myeloproliferative Neoplasms?
18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3; Life expectancy 3 months. 2. Diagnosed as Primary Myelofibrosis(PMF), Polycythemia Vera(PV), Essential Thrombocythemia(ET), Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post- Essential Thrombocythemia Myelofibrosis (PET-MF). 3. Myelofibrosis at intermediate risk -1 and above according to Dynamic International Prognostic Scoring System(DIPSS); PV or ET were resistant or intolerant to hydroxyurea and/or interferon therapy. 4. Adequate hematology laboratory index. 5.The most prominent part of the spleen 5cm to the lower edge of the ribs. 6.Bone marrow blasts and peripheral blood blasts <20%. 7\. Appropriate liver and kidney functions. 8.The main blood coagulation function is appropriate. 9. Those who have used other MPN treatment drugs before first dose need to stop exceed 2 weeks. Those who have received major surgery before first dose need to exceed 4 weeks
No pregnant or breastfeeding women, and a negative pregnancy test
Understood and signed an informed consent form

Exclusion Criteria

\. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. With exception of non-melanoma, skin cancer, and carcinoma in situ. 2. Has participated in other anticancer drug clinical trials within 4 weeks. 3. Has multiple factors affecting oral medication. 4. Has drug abuse history that unable to abstain from or mental disorders. 5. Has active hepatitis B or C, or immunodeficiency. 6\. Has immunodeficiency. 7. Has arteriovenous thrombosis events within 4 weeks. 8. Has received long-term and large-dose glucocorticoids or other immunosuppressive drugs within 28 days before signed the informed consent form. 9. Has serious systemic infections. 10. Has uncontrolled cardiovascular disease. 11. Has uncontrolled hypertension. 12. Has serious systemic infections. 13. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study
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