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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Jaktinib PO BID
Azacytidine SC
79 Qingchun Road
Hangzhou, Zhejiang, China
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.
Time frame: 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.
Time frame: Up to16 weeks
Overall survival
Will be listed and summarized by the Kaplan-Meier estimator
Time frame: 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
Time frame: 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 frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.