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New treatment option for Myelofibrosis
Official title A Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Myelofibrosis (MF)
ClinicalTrials.gov ID: NCT06122831
What this study is testing
What is TQ05105 Tablets?
TQ05105 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for myelofibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets combined with TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntary and signed informed consent, good compliance.
- Age: 18 or above (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2; Life...
- Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post PV MF), or post essential thrombocythemia...
- According to the dynamic international prognostic scoring system (DIPSS), patients with intermediate or high risk of bone marrow fibrosis were...
- Within 7 days before the first administration, the symptom score of myeloproliferative neoplasms should meet certain requirements.
You likely can't join if
- Patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before...
- Previous treatment with BET inhibitors combined with JAK inhibitor;
- Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
- Use of any MF medications, any immunomodulators, any immunosuppressive agents, within 2 weeks prior to first administration (There are separate...
- Other malignancies within 3 years prior to first administration or currently present.
- Patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal...
See the full eligibility criteria
Who can join
- Voluntary and signed informed consent, good compliance.
- Age: 18 or above (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2; Life expectancy ≥ 24 weeks.
- Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post PV MF), or post essential thrombocythemia myelofibrosis (post ET MF)
- According to the dynamic international prognostic scoring system (DIPSS), patients with intermediate or high risk of bone marrow fibrosis were evaluated.
- Within 7 days before the first administration, the symptom score of myeloproliferative neoplasms should meet certain requirements.
- Patients with poor how well it works of JAK inhibitors (for phase Ib and phase II cohort 2, cohort 3)
- Patients who had not received JAK inhibitor treatment (for phase II cohort 1).
- Spleen enlargement.
- Peripheral blood primary cells and bone marrow primary cells were ≤10%.
- No growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and the blood routine indexes met the requirements within 7 days before the first...
- The Main organ function is normal.
- Men and women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Serum human...
What rules you out
- Patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before the first administration, or recently planned stem cell transplantation;
- Previous treatment with BET inhibitors combined with JAK inhibitor;
- Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
- Use of any MF medications, any immunomodulators, any immunosuppressive agents, within 2 weeks prior to first administration (There are separate withdrawal requirements for hydroxyurea, JAK inhibitors, androgen drugs...
- Other malignancies within 3 years prior to first administration or currently present.
- 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;
- Major surgical treatment or significant traumatic injury within 4 weeks prior to first administration;
- Presence of congenital bleeding disorder and congenital coagulopathy;
- Patients who had arterial/venous thrombosis events within 6 months before the first administration.
- Have a history of mental drug abuse, or have a mental disorder.
- Active or uncontrolled severe infection;
- Active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection and HCV RNA positive, or active Corona Virus Disease 2019 (COVID-19) infection;
- Patients with grade III or above congestive heart failure, unstable angina pectoris or myocardial infarction, or arrhythmia requiring treatment, or QT interval prolongation within 6 months before the first...
- Unsatisfactory blood pressure control despite standard therapy;
- Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- Patients newly diagnosed with pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before the first administration;
- Patients with a history of immunodeficiency disease or organ transplantation;
- Patients with epilepsy requiring treatment;
- Patients who have received Chinese patent medicines with anti-tumor indications specified in the approved drug package insert of China National Medical Products Administration (NMPA) within 2 weeks before the first...
- Patients with uncontrolled pleural effusion, pericardial effusion or ascites;
- There was a history of attenuated live vaccine inoculation within 4 weeks before the first administration, or attenuated live vaccine inoculation was planned during the study period.
- People with known hypersensitivity to the study drug and excipients;
- Patients diagnosed as active autoimmune diseases within 2 years before the first administration;
- Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration (except JAK inhibitor-related clinical trials).
- According to the judgment of the investigators, some situations seriously endanger the safety of the people or affect the people to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Cangzhou, Hebei, China
- Chengde, Hebei, China
- Tangshan, Hebei, China
- Xingtai, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Hohhot, Inner Mongolia, China
- Wuxi, Jiangsu, China
- Changchun, Jilin, China
- Xi'an, Shaanxi, China
- Tai’an, Shandong, China
- Shanghai, Shanghai Municipality, China
- Changzhi, Shanxi, China
- Tianjin, Tianjin Municipality, China
- Ürümqi, Xinjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Nanning, Guangxi, China; Cangzhou, Hebei, China; Chengde, Hebei, China; Tangshan, Hebei, China; Xingtai, Hebei, China and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.