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Corporate policy adjustments
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib | Drug | Jaktinib PO BID |
| |
| azacitidine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Will be listed and summarized by the Kaplan-Meier estimator | Time from treatment start till death or last follow-up, assessed up to 2 years |
| Duration of response | Will be listed and summarized by the Kaplan-Meier estimator |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 79 Qingchun Road | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
Azacytidine SC |
|
| 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 | Will be listed and summarized by the Kaplan-Meier estimator | 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |