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Moderate and High Risk MyelofibrosisPhase 2NCT05020652

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

A Phase 2 study testing TQ05105 tablets and Hydroxycarbamide tablets in people with Moderate and High Risk Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Moderate and High Risk Myelofibrosis
What is being tested?
TQ05105 tablets and Hydroxycarbamide tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
4 sitesChina
Study dates
11 Nov 2021to 26 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%;
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  • 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.

Who cannot join

  • 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);
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  • 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;
  • Newly diagnosed pulmonary fibrosis or drug-related interstitial lung disease within 3 months before the date of randomization;
  • History of immunodeficiency, including Human Immunodeficiency Virus (HIV) positive or other acquired or congenital immunodeficiency diseases, or organ transplantation;
  • Patients with epilepsy and need treatment;
  • Within 4 weeks prior to the random date, the patient had received chemotherapy, radiotherapy or other anti-cancer treatments (except as stipulated in item 7 of the inclusion criteria);
  • Within 2 weeks before the date of randomization, he received Chinese patent medicines (including compound cantharis capsule, Kang'ai injection, kang'laite capsule / injection, Aidi injection, Brucea javanica oil injection / capsule, Xiaoaiping tablet / injection, cinobufagin capsule, etc.) with anti-tumor indications specified in nmpa approved drug instructions;
  • Uncontrolled pleural effusion, pericardial effusion or ascites;
  • Patients with central nervous system involvement;
  • There was a history of live attenuated vaccine inoculation within 4 weeks before the date of randomization or live attenuated vaccine inoculation was planned during the study period;

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100005

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

    Chengdu, Sichuan, 610041

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510055

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

    Tianjin, Tianjin Municipality, 300020

Other trials in China

About this study

Official title: A Randomized, Double Blind, Double Dummy, Parallel Controlled, Multicenter Phase II Clinical Trial of TQ05105 Tablets Versus Hydroxyurea Tablets in the Treatment of Moderate and High Risk Myelofibrosis

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

Being tested
TQ05105 tablets, Hydroxycarbamide tablets
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQ05105 tabletsDrug

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

  • Hydroxycarbamide tabletsDrug

    Hydroxycarbamide tablet is a nucleoside diphosphate reductase inhibitor.

Study groups in NCT05020652
Study groupRoleWhat they receive
TQ05105 tablets + Hydroxyurea blank tabletsExperimentalTake 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
Receives: Drug: TQ05105 tablets
TQ05105 blank tablets + Hydroxyurea tabletsActive comparatorTake 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
Receives: Drug: Hydroxycarbamide tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: up to 24 weeks

Secondary outcomes (10)

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

    Proportion of subjects whose spleen volume was reduced by more than 35% from baseline to the end of the 24th week assessed by the researchers and ORR

    Measured: up to 24 weeks

  2. optimal response rate of splenic response

    Proportion of subjects with at least one reduction in spleen volume ≥ 35% from baseline.

    Measured: up to 120 weeks

  3. onset time of splenic response

    The time between the date of randomization and the date when the spleen volume decreased ≥ 35% from the baseline for the first time.

    Measured: up to 120 weeks

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

    Duration of spleen volume reduction ≥ 35% from baseline (domsr): the time between the date when the spleen volume reduction ≥ 35% from baseline occurs for the first time and the date when the spleen volume reduction < 35% from baseline.

    Measured: up to 120 weeks

  5. 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

    At the 24th week, the proportion of subjects whose total symptom score of MPN-SAF TSS) decreased by more than 50% compared with baseline.

    Measured: up to 24 weeks

  6. The total symptom score of MPN-SAF TSS decreased compared with baseline

    The total symptom score of MPN-SAF TSS decreased compared with baseline;

    Measured: up to 24 weeks

  7. Progression-free survival (PFS)

    The interval from the random date to the date of occurrence of any of the following events, whichever occurs first: ① the spleen volume increases by ≥ 25% compared with the lowest value during the treatment period (including the screening period); ② Death from any cause; ③ Start other anti-MF treatments;

    Measured: up to 120 weeks

  8. Leukemia free survival (LFS)

    The time interval between the random date and the date of any of the following events, whichever occurs first, shall prevail: ① the date when the first bone marrow smear showed that the number of primordial cells was more than or equal to 20%; ② The first peripheral blood smear showed that the number of primordial cells was more than or equal to 20% and the absolute value of primordial cells was more than or equal to 1% × 10^9 / L for at least 2 weeks; ③ Death from any cause;

    Measured: up to 120 weeks

  9. Overall survival (OS)

    The time interval between the random date and death from any cause

    Measured: up to 120 weeks

  10. The incidence and severity of adverse events (AEs) occurred during the study

    The incidence and severity of AEs occurred during the study

    Measured: up to 120 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start11 Nov 2021
  3. Primary completion15 Oct 2023
  4. Study completion26 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05020652
Sponsor's protocol ID
TQ05105-II-01
Status last verified
Dec 2025
First submitted
23 Aug 2021
Last updated
2 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQ05105 tablets and Hydroxycarbamide tablets in people with Moderate and High Risk Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spleen Volume was Reduced by more than 35% from baseline（SVR35） assessed by Independent Review Committee (IRC) (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05020652.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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