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

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04866056
• Other study ID #: ZGJAK019
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 30, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: November 2022
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 10, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Myelofibrosis
• Myeloproliferative Disorders
• Myeloproliferative Neoplasms
• Neoplasms
• Preleukemia
• Primary Myelofibrosis
• Syndrome

Intervention

Drug:
• Jaktinib
Jaktinib PO BID
• azacitidine
Azacytidine SC

Locations

Country	Name	City	State
China	79 Qingchun Road	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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