MyelofibrosisNCT07342712
Clinical Trail to Evaluate the Effect of Long-term Treatment With Gecacitinib on Myelofibrosis and Gene Mutation Levels
An observational study of Myelofibrosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This study was an observational study, and about 40 patients with intermediate and high risk myelofibrosis who had participated in any previous clinical study of Gecacitinib hydrochloride and were still receiving Gecacitinib treatment in our center were expected to be enrolled. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myelofibrosis
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 7 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study was an observational study, and about 40 patients with intermediate and high risk myelofibrosis who had participated in any previous clinical study of Gecacitinib hydrochloride and were still receiving Gecacitinib treatment in our center were expected to be enrolled. There was no additional drug intervention, only the myelofibrosis grade and gene mutation level of the patients were collected. Subjects who met all inclusion criteria and none of the exclusion criteria were eligible for inclusion in this study.
Who may be able to join
- They had been enrolled in previous clinical trials of gefitinib for myelofibrosis (ZGJAK002, ZGJAK006, ZGJAK016 and ZGJAK017) and were still receiving gefitinib treatment.
- Comply with the requirements of the ethics committee, voluntarily sign the informed consent.
- Able to adhere to study and follow-up procedures.
Who cannot join
- Patients with other serious diseases that the researcher believes may affect patient compliance and outcome observation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: A Phase ⅢB Clinical Trial Evaluating the Long-term Effects of Gecacitinib Treatment on Myelofibrosis and Gene Mutation Levels in Patients Previously Enrolled in Clinical Trails of Gecacitinib for the Treatment of Myelofibrosis
This study was an observational study, and about 40 patients with intermediate and high risk myelofibrosis who had participated in any previous clinical study of Gecacitinib hydrochloride and were still receiving Gecacitinib treatment in our center were expected to be enrolled. There was no additional drug intervention, only the myelofibrosis grade and gene mutation level of the patients were collected. Subjects who met all inclusion criteria and none of the exclusion criteria were eligible for inclusion in this study. After informed consent was obtained and screening was successful, bone marrow aspiration, bone marrow biopsy, and gene mutation testing were performed once. If bone marrow was extracted, peripheral blood could be used for gene mutation testing, and then annually until the permanent discontinuation of Gecacitinib.
Read the detailed description
Previous clinical trials of Gecacitinib hydrochloride tablets in the treatment of myelofibrosis initiated by our center include: 1) ZGJAK002 trial (NCT03886415) : A multicenter phase Ⅱ clinical trial of the safety and efficacy of 100mg BID and 200mg QD of Gecacitinib in the treatment of intermediate and high risk myelofibrosis (n=118). 2) ZGJAK006 study (NCT04217993) : a phase ⅡB clinical trial of the safety and efficacy of gefitinib in Ruxolitinib intolerant myelofibrosis patients (n=51); 3) ZGJAK017 study (NCT04851535) : a phase Ⅱ trial (n=34) to evaluate the efficacy and safety of Gecacitinib in Ruxolitinib refractory or relapsed myelofibrosis patients; 4) ZGJAK016 trial (NCT04617028) : a randomized, double-blind, double-dummy, parallel-controlled, multicenter phase III trial (n=105). At present, the follow-up of the project has ended and the Gecacitinib donation phase has begun.
This study was an observational study, and about 40 patients with intermediate and high risk myelofibrosis who had participated in any previous clinical study of Gecacitinib hydrochloride and were still receiving Gecacitinib treatment in our center were expected to be enrolled. There was no additional drug intervention, only the myelofibrosis grade and gene mutation level of the patients were collected. Subjects who met all inclusion criteria and none of the exclusion criteria were eligible for inclusion in this study. After informed consent was obtained and screening was successful, bone marrow aspiration, bone marrow biopsy, and gene mutation testing were performed once. If bone marrow was extracted, peripheral blood could be used for gene mutation testing, and then annually until the permanent discontinuation of Gecacitinib.
The primary objective was to evaluate the myelofibrosis grade in patients with MF who had previously participated in a clinical study of Gecacitinib and were still receiving gefitinib. The secondary objective was to evaluate the change from baseline in JAK2 isomutations.
- Conditions
- Myelofibrosis
- Medical subject headings
- Primary Myelofibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with worsening/stable/improving myelofibrosis grade after treatment
Sample collection: Bone marrow biopsy tissue was at least 1.5 cm in length to ensure accuracy of bone marrow analysis. The bone marrow fibers were graded by silver staining to ensure the objectivity and reproducibility of the grading results
Measured: Successfully enrolled patients will undergo bone marrow biopsy as indicated by follow-up, and then once per 1 year until Gecacitinib is permanently discontinued or assessed up to 5 years, whichever came first.
Secondary outcomes (1)
The changes of JAK2 V617F, CALR and MPL W515L/K gene mutations after treatment were compared with those before treatment
Sample collection: Approximately 3-5 mL of forearm venous blood was collected to ensure adequate blood volume for molecular biological quantitative analysis
Measured: Successfully enrolled patients will undergo genetic testing as indicated by follow-up, and then once per 1 year until Gecacitinib is permanently discontinued or assessed up to 5 years, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion7 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342712
- Sponsor's protocol ID
- IIT20250082B-R2
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Zhou H, Jiang Z, Wu D, Zhuang J, Li W, Jiang Q, Wang X, Huang J, Zhu H, Yang L, Du X, Li F, Xia R, Zhang F, Hu J, Li Y, Hu Y, Liu J, Jin C, Sun K, Zhou Z, Wu L, Yu W, Jin J. Safety and efficacy of jaktinib in the treatment of Janus kinase inhibitor-naive patients with myelofibrosis: Results of a phase II trial. Am J Hematol. 2022 Dec;97(12):1510-1519. doi: 10.1002/ajh.26709. Epub 2022 Oct 4.
PubMed 36054786Zhang Y, Zhou H, Duan M, Gao S, He G, Jing H, Li J, Ma L, Zhu H, Chang C, Du X, Hong M, Li X, Liu Q, Wang W, Xu N, Yang H, Lu B, Yin H, Wu L, Suo S, Zhao Q, Xiao Z, Jin J. Safety and efficacy of jaktinib (a novel JAK inhibitor) in patients with myelofibrosis who are intolerant to ruxolitinib: A single-arm, open-label, phase 2, multicenter study. Am J Hematol. 2023 Oct;98(10):1588-1597. doi: 10.1002/ajh.27033. Epub 2023 Jul 20.
PubMed 37470365Zhang Y, Zhou H, Suo S, Zhuang J, Yang L, He A, Liu Q, Du X, Gao S, Li Y, Li Y, Chen Y, Wu W, Zhu H, He G, Hong M, Jiang Q, Jiang Z, Jing H, Wang J, Xu N, Yue L, Zheng C, Zhou Z, Jin C, Li X, Liu L, Xu Y, Wu D, Zhang F, Zhang J, Wu L, Yin H, Lv B, Xiao Z, Jin J. Evaluation of gecacitinib vs hydroxyurea in patients with intermediate-2 or high-risk myelofibrosis: final analysis results from a randomized phase 3 study. Blood Cancer J. 2024 Dec 18;14(1):216. doi: 10.1038/s41408-024-01202-8.
PubMed 39695117Zhang Y, Zhang Q, Liu Q, Dang H, Gao S, Wang W, Zhou H, Chen Y, Ma L, Wang J, Yang H, Lu B, Yin H, Wu L, Suo S, Zhao Q, Tong H, Jin J. Safety and efficacy of jaktinib (a novel JAK inhibitor) in patients with myelofibrosis who are relapsed or refractory to ruxolitinib: A single-arm, open-label, phase 2, multicenter study. Am J Hematol. 2023 Oct;98(10):1579-1587. doi: 10.1002/ajh.27031. Epub 2023 Jul 19.
PubMed 37466271
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase ⅢB Clinical Trial Evaluating the Long-term Effects of Gecacitinib Treatment on Myelofibrosis and Gene Mutation Levels in Patients Previously Enrolled in Clinical Trails of Gecacitinib for the Treatment of Myelofibrosis
- ClinicalTrials.gov ID
- NCT07342712
- Acronym / sponsor ID
- IIT20250082B-R2
- Conditions
- Myelofibrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 7 Dec 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was an observational study, and about 40 patients with intermediate and high risk myelofibrosis who had participated in any previous clinical study of Gecacitinib hydrochloride and were still receiving Gecacitinib treatment in our center were expected to be enrolled. There was no additional drug intervention, only the myelofibrosis grade and gene mutation level of the patients were collected. Subjects who met all inclusion criteria and none of the exclusion criteria were eligible for inclusion in this study. After informed consent was obtained and screening was successful, bone marrow aspiration, bone marrow biopsy, and gene mutation testing were performed once. If bone marrow was extracted, peripheral blood could be used for gene mutation testing, and then annually until the permanent discontinuation of Gecacitinib.
Detailed description
Previous clinical trials of Gecacitinib hydrochloride tablets in the treatment of myelofibrosis initiated by our center include: 1) ZGJAK002 trial (NCT03886415) : A multicenter phase Ⅱ clinical trial of the safety and efficacy of 100mg BID and 200mg QD of Gecacitinib in the treatment of intermediate and high risk myelofibrosis (n=118). 2) ZGJAK006 study (NCT04217993) : a phase ⅡB clinical trial of the safety and efficacy of gefitinib in Ruxolitinib intolerant myelofibrosis patients (n=51); 3) ZGJAK017 study (NCT04851535) : a phase Ⅱ trial (n=34) to evaluate the efficacy and safety of Gecacitinib in Ruxolitinib refractory or relapsed myelofibrosis patients; 4) ZGJAK016 trial (NCT04617028) : a randomized, double-blind, double-dummy, parallel-controlled, multicenter phase III trial (n=105). At present, the follow-up of the project has ended and the Gecacitinib donation phase has begun.
This study was an observational study, and about 40 patients with intermediate and high risk myelofibrosis who had participated in any previous clinical study of Gecacitinib hydrochloride and were still receiving Gecacitinib treatment in our center were expected to be enrolled. There was no additional drug intervention, only the myelofibrosis grade and gene mutation level of the patients were collected. Subjects who met all inclusion criteria and none of the exclusion criteria were eligible for inclusion in this study. After informed consent was obtained and screening was successful, bone marrow aspiration, bone marrow biopsy, and gene mutation testing were performed once. If bone marrow was extracted, peripheral blood could be used for gene mutation testing, and then annually until the permanent discontinuation of Gecacitinib.
The primary objective was to evaluate the myelofibrosis grade in patients with MF who had previously participated in a clinical study of Gecacitinib and were still receiving gefitinib. The secondary objective was to evaluate the change from baseline in JAK2 isomutations.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study was an observational study, and about 40 patients with intermediate and high risk myelofibrosis who had participated in any previous clinical study of Gecacitinib hydrochloride and were still receiving Gecacitinib treatment in our center were expected to be enrolled. There was no additional drug intervention, only the myelofibrosis grade and gene mutation level of the patients were collected. Subjects who met all inclusion criteria and none of the exclusion criteria were eligible for inclusion in this study.
Key inclusion criteria (3 listed)
- They had been enrolled in previous clinical trials of gefitinib for myelofibrosis (ZGJAK002, ZGJAK006, ZGJAK016 and ZGJAK017) and were still receiving gefitinib treatment.
- Comply with the requirements of the ethics committee, voluntarily sign the informed consent.
- Able to adhere to study and follow-up procedures.
Key exclusion criteria (1 listed)
- Patients with other serious diseases that the researcher believes may affect patient compliance and outcome observation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with worsening/stable/improving myelofibrosis grade after treatment
Time frame: Successfully enrolled patients will undergo bone marrow biopsy as indicated by follow-up, and then once per 1 year until Gecacitinib is permanently discontinued or assessed up to 5 years, whichever came first.
Sample collection: Bone marrow biopsy tissue was at least 1.5 cm in length to ensure accuracy of bone marrow analysis. The bone marrow fibers were graded by silver staining to ensure the objectivity and reproducibility of the grading results
1 secondary outcome
The changes of JAK2 V617F, CALR and MPL W515L/K gene mutations after treatment were compared with those before treatment
Time frame: Successfully enrolled patients will undergo genetic testing as indicated by follow-up, and then once per 1 year until Gecacitinib is permanently discontinued or assessed up to 5 years, whichever came first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Background: PubMed 36054786Zhang Y, Zhou H, Jiang Z, Wu D, Zhuang J, Li W, Jiang Q, Wang X, Huang J, Zhu H, Yang L, Du X, Li F, Xia R, Zhang F, Hu J, Li Y, Hu Y, Liu J, Jin C, Sun K, Zhou Z, Wu L, Yu W, Jin J. Safety and efficacy of jaktinib in the treatment of Janus kinase inhibitor-naive patients with myelofibrosis: Results of a phase II trial. Am J Hematol. 2022 Dec;97(12):1510-1519. doi: 10.1002/ajh.26709. Epub 2022 Oct 4.
- Background: PubMed 37470365Zhang Y, Zhou H, Duan M, Gao S, He G, Jing H, Li J, Ma L, Zhu H, Chang C, Du X, Hong M, Li X, Liu Q, Wang W, Xu N, Yang H, Lu B, Yin H, Wu L, Suo S, Zhao Q, Xiao Z, Jin J. Safety and efficacy of jaktinib (a novel JAK inhibitor) in patients with myelofibrosis who are intolerant to ruxolitinib: A single-arm, open-label, phase 2, multicenter study. Am J Hematol. 2023 Oct;98(10):1588-1597. doi: 10.1002/ajh.27033. Epub 2023 Jul 20.
- Background: PubMed 39695117Zhang Y, Zhou H, Suo S, Zhuang J, Yang L, He A, Liu Q, Du X, Gao S, Li Y, Li Y, Chen Y, Wu W, Zhu H, He G, Hong M, Jiang Q, Jiang Z, Jing H, Wang J, Xu N, Yue L, Zheng C, Zhou Z, Jin C, Li X, Liu L, Xu Y, Wu D, Zhang F, Zhang J, Wu L, Yin H, Lv B, Xiao Z, Jin J. Evaluation of gecacitinib vs hydroxyurea in patients with intermediate-2 or high-risk myelofibrosis: final analysis results from a randomized phase 3 study. Blood Cancer J. 2024 Dec 18;14(1):216. doi: 10.1038/s41408-024-01202-8.
- Background: PubMed 37466271Zhang Y, Zhang Q, Liu Q, Dang H, Gao S, Wang W, Zhou H, Chen Y, Ma L, Wang J, Yang H, Lu B, Yin H, Wu L, Suo S, Zhao Q, Tong H, Jin J. Safety and efficacy of jaktinib (a novel JAK inhibitor) in patients with myelofibrosis who are relapsed or refractory to ruxolitinib: A single-arm, open-label, phase 2, multicenter study. Am J Hematol. 2023 Oct;98(10):1579-1587. doi: 10.1002/ajh.27031. Epub 2023 Jul 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with worsening/stable/improving myelofibrosis grade after treatment (time frame: Successfully enrolled patients will undergo bone marrow biopsy as indicated by follow-up, and then once per 1 year until Gecacitinib is permanently discontinued or assessed up to 5 years, whichever came first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07342712, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.