Status:
TERMINATED
Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Myelodysplastic Syndromes
Myeloproliferative Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial studies how well Jaktinib and azacytidine work in treating patients with myelodysplastic syndromes with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm with...
Eligibility Criteria
Inclusion
- Subjects voluntarily sign the informed consent form (ICF);
- Age ≥ 18 years, either male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Expected life expectancy is greater than 24 weeks;
- Diagnosis of myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) according to World Health Organization (WHO)；
- The patients understands the purpose of and procedures required for the study and is willing to participate in the study；
Exclusion
- Subjects with congestive heart failure, uncontrolled or unstable angina or myocardial infarction,cerebrovascular accident, or pulmonary embolism within 6 months prior to screening;
- Subjects suffering from arrhythmia and requiring treatment, or QTcB \> 480ms at screening;
- Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening;
- Subjects with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC);
- Female subjects who are pregnant, currently breastfeeding, planning to become pregnant;
- Subjects who had experienced malignant tumors (except for adequately treated local basal cell or squamous cell carcinoma of the skin and cervical carcinoma in situ that have been cured) within the past 5 years;
- Subjects who have any other conditions that are not specified in the protocol but the investigator believes that they are not suitable for inclusion in this trial.
Key Trial Info
Start Date :
September 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2022
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04866056
Start Date
September 30 2021
End Date
June 10 2022
Last Update
December 1 2022
Active Locations (1)
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1
79 Qingchun Road
Hangzhou, Zhejiang, China