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The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VA-PD1i | Experimental | Patients are treated with PD-1 inhibitor combined with venetoclax and decitabine/azacytidine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine | Drug | For AML patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. For MDS patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 14 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. The venetoclax starting dose is 100 mg on the first day, ramping up to 200 mg on the second day and finally 400 mg once daily. The steady daily dose (after ramp-up phase) should be reduced to 100 mg (coadministered with moderate CYP3A inhibitors or P-gp inhibitors) and 70 mg (coadministered with strong CYP3A4 inhibitors). |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi) | At the end of Cycle 2 (each cycle is 28 days) |
| Complete minimal residual disease (MRD) Response Rate | Percentage of subjects with MRD negative or MRD < 0.01% | At the end of Cycle 2 (each cycle is 28 days) |
| MRD Response Rate | Percentage of subjects with MRD < 0.1% detectable by multicolor flow cytometry | At the end of Cycle 2 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-Free Survival | Time interval from leukemia free state to the first recurrence or death | 24 months |
| Overall Survival | Time interval from start of treatment until death or last follow-up |
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Inclusion Criteria:
Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.
Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.
Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
The toxic and side effects caused by the last treatment should be recovered.
Eastern Cooperative Oncology Group score of 0 to 3 points.
The organ function is intact.
Karnofsky≥70.
The expected survival period is at least 12 weeks.
Non-pregnant, non-breastfeeding women.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiao-ning Gao | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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| 24 months |
| Duration of response | Time interval from morphologic/MRD response to loss of response or death | 24 months |
| Adverse events | Number of subjects with adverse events | start of treatment to 2 weeks after end of treatment |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| C579720 | venetoclax |
| D000077209 | Decitabine |
| D001374 | Azacitidine |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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