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

NCT ID: NCT04866056

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-06-10

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.

Conditions

Myelodysplastic Syndromes; Myeloproliferative Neoplasms; Myelofibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment(Jaktinib+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.

Group Type: EXPERIMENTAL

Jaktinib

Intervention Type: DRUG

Jaktinib PO BID

azacitidine

Intervention Type: DRUG

Azacytidine SC

Interventions

Jaktinib

Jaktinib PO BID

Intervention Type: DRUG

azacitidine

Azacytidine SC

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

79 Qingchun Road

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZGJAK019

Identifier Type: -

Identifier Source: org_study_id