Tislelizumab with Azacitidine in the Treatment of R/R AML

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Relapsed Adult AML; Refractory AML

Treatments: Drug: Aza, tislelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06586099

IIT2020007

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of AML according to FAB or WHO criteria
• refractory or morphological relapsed AML
• age over 18 years old
• ECOG PS 0-2
• written informed consent

Exclusion criteria

• acute promyelocyte leukemia
• solitary extramedullary relapsed disease
• other hematological diseases
• antecedent stem cell transplantation
• AML with BCR_ABL positive
• acute panmyelosis with myelofibrosis or sarcoma
• with other active organ malignancy(needing treatment)
• active heart diseases
• unfit for enrollment after investigator's evaluation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

treatment arm

Experimental group

Description:

azacytidine 75mg/m2/d, IH,day1-7, every 28 days for three cycles tislelizumab 200mg,day 8,every three weeks, for 4 doses

Treatment:

Drug: Aza, tislelizumab