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

Phase 1

Terminated

• Conditions: Myelodysplastic Syndromes; Myeloproliferative Neoplasms; Myelofibrosis
• Interventions: Drug: Jaktinib; Drug: azacitidine

• Registration Number: NCT04866056
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-29
• Study Start: 2021-09-30
• Primary Completion: 2022-06-10
• Study Completion: 2022-06-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment(Jaktinib+Azacitidine)	azacitidine	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.
Treatment(Jaktinib+Azacitidine)	Jaktinib	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

79 Qingchun Road; 🇨🇳 Hangzhou, Zhejiang, China