TQB3909 tablets combined with azacitidine for myeloid malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1/2 study gives investigational oral TQB3909 in combination with standard azacitidine to adults with myeloid malignancies including AML and MDS. Phase 1 will determine safety, tolerability, and a recommended dose while Phase 2 will look for signals of efficacy. Participants will have regular blood tests, bone marrow assessments, and monitoring for adverse events during treatment. The trial is conducted at several hospitals in China and enrolls adults with adequate organ function who can take oral medication.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntary and signed informed consent, good compliance
* Age: ≥18 years old (at the time of signing the informed consent); expected survival time greater than 3 months.
* Diagnosis of one of the following diseases:

  1. Acute Myeloid Leukemia (AML):
  2. Myelodysplastic Syndromes (MDS)
  3. Major organ functions are normal.
  4. Fertile male and female subjects agree to use contraception during the study and for 6 months after the study ends.

Exclusion Criteria:

* Comorbidities and Medical History:

  1. Diagnosis of or current concomitant malignancy within 3 years prior to the first dose;
  2. Presence of multiple factors affecting oral drug intake and/or absorption;
  3. Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose;
  4. History of arterial/venous thrombotic events within 6 months prior to the first dose;
  5. History of psychiatric drug abuse that cannot be discontinued, or psychiatric disorders;
  6. Presence of any severe and/or uncontrolled disease in the subject.
* Tumor-related Symptoms and Treatment:

  1. Diagnosis of Acute Promyelocytic Leukemia (APL), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN);
  2. Presence of leukemia central nervous system (CNS) involvement or high suspicion of CNS involvement but unable to confirm;
  3. Subjects with extramedullary disease only in AML;
  4. Presence of life-threatening severe leukemia-related complications;
* Study Treatment-related:

  1. Received live vaccines within 4 weeks prior to the first dose, or planned to receive live vaccines during the study period;
  2. Participated in other clinical trials involving anti-tumor drugs within 4 weeks prior to the first dose.

Where it's running

• ShangHai Tongren Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Not yet recruiting
• Beijing Chaoyang Hospital Affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Affiliated Hospital of Chengde Medical University
  Chengde, Hebei, China Not yet recruiting

Study contacts

• Study coordinator: JianXiang Wang, Master
• Email: wangjx@ihcams.ac.cn
• Phone: 13821389157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.