Tislelizumab with Azacitidine in the Treatment of R/R AML

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-05

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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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

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Refractory AML Relapsed Adult AML

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, open label, single arm clinical study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment arm

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

Group Type EXPERIMENTAL

Aza, tislelizumab

Intervention Type DRUG

combination chemotherapy for the refractory/relapsed AML

Interventions

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Aza, tislelizumab

combination chemotherapy for the refractory/relapsed AML

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No