Status:
WITHDRAWN
Tislelizumab with Azacitidine in the Treatment of R/R AML
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Refractory AML
Relapsed Adult AML
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 achiev...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06586099
Start Date
October 5 2024
End Date
June 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
HBDH
Tianjin, Tianjin Municipality, China, 300020