Refractory AML, Relapsed Adult AML
Conditions
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 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.
Interventions
DRUGAza, tislelizumab
combination chemotherapy for the refractory/relapsed AML
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, open label, single arm clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite complete remission rate | up to 2 years | including complete remission plus complete remission with incomplete blood cell count recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | up to 4 years | The interval from the date of enrollment to the date of death or the date of last follow-up, whichever occurred first. |
| disease free survival | up to 4 years | From CR1 to relapse, death from any cause or last follow-up |
Countries
China
Outcome results
None listed