Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): withdrawn
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Relapsed Adult AML | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aza, tislelizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- azacytidine 75mg/m2/d, IH,day1-7, every 28 days for three cycles tislelizumab 200mg,day 8,every three weeks, for 4 doses
- interventionNames
- Drug: Aza, tislelizumab
Primary outcomes (1)
- measure
- composite complete remission rate
- timeFrame
- up to 2 years
- description
- including complete remission plus complete remission with incomplete blood cell count recovery
Secondary outcomes (2)
- measure
- overall survival
- timeFrame
- up to 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available