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

Primary Purpose

Myelodysplastic Syndromes, Myeloproliferative Neoplasms, Myelofibrosis

Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Jaktinib
azacitidine
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring MDS, MF, MPN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 79 Qingchun Road

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment(Jaktinib+Azacitidine)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Overall survival
Will be listed and summarized by the Kaplan-Meier estimator
Duration of response
Will be listed and summarized by the Kaplan-Meier estimator
Relapse-free survival
Will be listed and summarized by the Kaplan-Meier estimator

Full Information

First Posted
April 28, 2021
Last Updated
November 28, 2022
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04866056
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Corporate policy adjustments
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
June 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes, Myeloproliferative Neoplasms, Myelofibrosis
Keywords
MDS, MF, MPN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment(Jaktinib+Azacitidine)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Jaktinib
Intervention Description
Jaktinib PO BID
Intervention Type
Drug
Intervention Name(s)
azacitidine
Intervention Description
Azacytidine SC
Primary Outcome Measure Information:
Title
Objective response rate (complete remission+partial remission+marrow compete remission +cytogenetic complete remission + hematological improvement) in patients with Myelodysplastic Syndromes
Description
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.
Time Frame
Up to16 weeks
Title
Objective response rate (complete remission+cytogenetic complete remission+partial remission+clinical improvement) in patients with myelodysplastic syndromes/myeloproliferative neoplasms
Description
According to the 2015 ICP in MDS/MPN. The objective response rate will be estimated along with the Bayesian 95% credible interval.
Time Frame
Up to16 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Description
Will be listed and summarized by the Kaplan-Meier estimator
Time Frame
Time from treatment start till death or last follow-up, assessed up to 2 years
Title
Duration of response
Description
Will be listed and summarized by the Kaplan-Meier estimator
Time Frame
Duration from the first documented onset of partial response or complete response to the date of progressive disease/relapse, assessed up to 2 years
Title
Relapse-free survival
Description
Will be listed and summarized by the Kaplan-Meier estimator
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
79 Qingchun Road
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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