Myelodysplastic Syndromes, Myeloproliferative Neoplasms, Myelofibrosis
Conditions
Keywords
MDS, MF, MPN
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 myelofibrosis. Giving Jaktinib and azacytidine may be an effective treatment for myelodysplastic syndromes with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm with myelofibrosis.
Interventions
DRUGJaktinib
Jaktinib PO BID
DRUGazacitidine
Azacytidine SC
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (complete remission+partial remission+marrow compete remission +cytogenetic complete remission + hematological improvement) in patients with Myelodysplastic Syndromes | Up to16 weeks | 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. |
| Objective response rate (complete remission+cytogenetic complete remission+partial remission+clinical improvement) in patients with myelodysplastic syndromes/myeloproliferative neoplasms | Up to16 weeks | According to the 2015 ICP in MDS/MPN. The objective response rate will be estimated along with the Bayesian 95% credible interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Time from treatment start till death or last follow-up, assessed up to 2 years | Will be listed and summarized by the Kaplan-Meier estimator |
| Duration of response | Duration from the first documented onset of partial response or complete response to the date of progressive disease/relapse, assessed up to 2 years | Will be listed and summarized by the Kaplan-Meier estimator |
| Relapse-free survival | 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 | Will be listed and summarized by the Kaplan-Meier estimator |
Countries
China
Outcome results
None listed