A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosis (NCT05020652) | Clinical Trial Compass
CompletedPhase 2
A Clinical Trial of TQ05105 Tablets in the Treatment of Moderate and High Risk Myelofibrosis
China107 participantsStarted 2021-11-11
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Spleen Volume was Reduced by more than 35% from baseline（SVR35） assessed by Independent Review Committee (IRC)
Timeframe: up to 24 weeks
Trial details
NCT IDNCT05020652
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
. 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;
Exclusion criteria
. 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;