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

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04866056
Collaborator
(none)
56
1
15.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Jaktinib
Jaktinib PO BID

Drug: azacitidine
Azacytidine SC

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT04866056
Other Study ID Numbers:
  • ZGJAK019
First Posted:
Apr 29, 2021
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021