Clinical trial NCT04866056: Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndromes
Myeloproliferative Neoplasms
Myelofibrosis
Keywords: MDS
MF
MPN
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate (complete remission+partial remission+marrow compete remission +cytogenetic complete remission + hematological improvement) in patients with Myelodysplastic Syndromes
timeFrame: Up to16 weeks
measure: Objective response rate (complete remission+cytogenetic complete remission+partial remission+clinical improvement) in patients with myelodysplastic syndromes/myeloproliferative neoplasms
timeFrame: Up to16 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: Time from treatment start till death or last follow-up, assessed up to 2 years
measure: Duration of response
timeFrame: Duration from the first documented onset of partial response or complete response to the date of progressive disease/relapse, assessed up to 2 years
measure: Relapse-free survival
timeFrame: 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
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 79 Qingchun Road
state: Zhejiang
Study officials:
References: