Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.

Study Overview
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Brief Summary
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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 myelofibrosis. Giving Jaktinib and azacytidine may be an effective treatment for myelodysplastic syndromes with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm with myelofibrosis.

Official Title
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A Multicentric Phase I/II Study of Jaktinib Hydrochloride Tablets in Combination With Azacitidine for Injection in Patients With Myelodysplastic Syndromes(MDS) With Myelofibrosis(MF) or MDS/Myeloproliferative Neoplasms With MF

Conditions
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Myelodysplastic Syndromes, Myeloproliferative Neoplasms, Myelofibrosis

Intervention / Treatment
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* Drug: Jaktinib
* Drug: azacitidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment(Jaktinib+Azacitidine)<br>Patients receive azacitidine subcutaneously (SC) on days 1-7 and Jaktinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. | Drug: Jaktinib<br>* Jaktinib PO BID<br>Drug: azacitidine<br>* Azacytidine SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (complete remission+partial remission+marrow compete remission +cytogenetic complete remission + hematological improvement) in patients with Myelodysplastic Syndromes | According to the 2006 International Working Group (IWG) response criteria in myelodysplasia，The objective response rate will be estimated along with the Bayesian 95% credible interval. | Up to16 weeks | 
| Objective response rate (complete remission+cytogenetic complete remission+partial remission+clinical improvement) in patients with myelodysplastic syndromes/myeloproliferative neoplasms | According to the 2015 ICP in MDS/MPN. The objective response rate will be estimated along with the Bayesian 95% credible interval. | Up to16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Will be listed and summarized by the Kaplan-Meier estimator | Time from treatment start till death or last follow-up, assessed up to 2 years | 
| Duration of response | Will be listed and summarized by the Kaplan-Meier estimator | Duration from the first documented onset of partial response or complete response to the date of progressive disease/relapse, assessed up to 2 years | 
| Relapse-free survival | Will be listed and summarized by the Kaplan-Meier estimator | Time from start of response to the date of event defined as the first documented progressive disease/relapse or death, whichever comes first, assessed up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDS, MF, MPN