Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586099
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2020-07-05
Brief Title:
Tislelizumab with Azacitidine in the Treatment of RR AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Open-label Single Arm Trial to Evaluate Efficacy and Safety of Tislelizumab with Azacitidine in the Treatment of Refractoryrelapsed Acute Myeloid Leukemia
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
withdrawn
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute myeloid leukemiaAML is a clonal hematological malignancy 50-90 adult AML patients can achieve complete remissionCR after standard induction chemotherapybut 10-25 patients cannot achieve CR which is called primary refractory diseaseMost of patients who achieved CR will relapse during the next 3 years and the prognosis is poorSo refractory and relapse diseases are still the hotspot of clinical researchImmunologic escape is one of the mechanisms for tumor cells to survive from chemotherapy Studies have shown that PD1 and PDL1 levels are upregulated in AML patients the same phenomenon was observed after the treatment of demethylating agents such as azacytidine Combination of PD1 blockades with azacytidine may improve the efficacy of the treatment
Detailed Description:
In this phase 12 study 20 patients will be enrolled and treated with azacytidine and tislelizumab regimen The primary endpoint is composite complete remission rateToxicities of treatment need to be observed And relationship between PDL1 expression on AML cells and efficacy will be studied Treatments include azacytidine 75mgm2d subcutaneous injectionday1-7 every 28 days for three cycles tislelizumab 200mgday 8every three weeks for 4 doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None