NCT06586099

Tislelizumab with Azacitidine in the Treatment of R/R AML

Prospective, Open-label, Single Arm Trial to Evaluate Efficacy and Safety of Tislelizumab with Azacitidine in the Treatment of Refractory/relapsed Acute Myeloid Leukemia

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute myeloid leukemia(AML) is a clonal hematological malignancy. 50%-90% adult AML patients can achieve complete remission(CR) after standard induction chemotherapy,but 10%-25% patients cannot achieve CR, which is called 'primary refractory disease'.Most of patients who achieved CR will relapse during the next 3 years, and the prognosis is poor.So refractory and relapse diseases are still the hotspot of clinical research.Immunologic 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 1/2 study, 20 patients will be enrolled and treated with azacytidine and tislelizumab regimen. The primary endpoint is composite complete remission rate.Toxicities of treatment need to be observed. And relationship between PDL1 expression on AML cells and efficacy will be studied. Treatments include azacytidine 75mg/m2/d, subcutaneous injection,day1-7, every 28 days for three cycles tislelizumab 200mg,day 8,every three weeks, for 4 doses.

Conditions

• Refractory AML
• Relapsed Adult AML

Interventions

Type	Name	Description
DRUG	Aza, tislelizumab	combination chemotherapy for the refractory/relapsed AML

Timeline

• Start date: 2024-10-05
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China