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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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This study aims to evaluate the efficacy and safety of PD-1 inhibitor, Azacitidine, and low-dose DLI in AML relapse After allogeneic hematopoietic stem cell transplantation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab, Azacitidine and low-dose Donor lymphocyte infusion | Experimental | Patients are given azacytidine for 7 days, followed by 4 DLI treatments on Days 10, 17, 24 and 31, with the dose of DLI and Camrelizumab adjusted according to the donor source. Camrelizumab infusions were given 3 hours after completion of the 1st and 3rd DLIs, respectively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine | Drug | Azacitidine 75 mg/m2 subcutaneously once daily on days 1-7. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The overall response (completed remission, completed remission with incomplete blood count recovery) | ORR assessment is at day 39 (±2). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is measured from the time of enrollment to this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive. | 2 years |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng-Li Xue, M.D. | Contact | +86 512 6778 1139 | slxue@suda.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C000631724 | camrelizumab |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Donor lymphocyte infusion | Biological | The 4 DLI doses (dose range: ±10%) of sib-matched donor HSCT patients were 1×10^6/kg, 5×10^6/kg, 1×10^7/kg, 5×10^7/kg; The 4 DLI doses (dose range: ±10%) of haploidentical or unrelated donor HSCT patients were 1×10^5/kg, 5×10^5/kg, 1×10^6/kg, 5×10^6/kg. |
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| Camrelizumab | Drug | Camrelizumab 200mg Q2W for sib-matched donor HSCT patients, 100mg Q2W for haploidentical or unrelated donor HSCT patients. |
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PFS is measured from the time of enrollment to this study to progression or death. |
| 2 years |
| Adverse events | It is evaluated and graded according to CTCAE 5.0. | 1 month |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |