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

NCT04866056 | Terminated Phase 1

• 1 other identifier: ZGJAK019
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

MDS; MF; MPN

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Overall survival

  Time from treatment start till death or last follow-up, assessed up to 2 years

• 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

• 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

Study Arms (1)

Treatment(Jaktinib+Azacitidine)

EXPERIMENTAL

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.

Drug: Jaktinib; Drug: azacitidine

Interventions

Jaktinib DRUG

Jaktinib PO BID

Treatment(Jaktinib+Azacitidine)

azacitidine DRUG

Azacytidine SC

Treatment(Jaktinib+Azacitidine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

79 Qingchun Road

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Myeloproliferative Disorders; Primary Myelofibrosis

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 29, 2021
• Study Start: September 30, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

CN (1)