Tislelizumab with Azacitidine in the Treatment of R/R AML

NCT06586099 | Withdrawn Phase 1

• 1 other identifier: IIT2020007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory AML; Relapsed Adult AML

Outcome Measures

Primary Outcomes (1)

• composite complete remission rate

  including complete remission plus complete remission with incomplete blood cell count recovery

  up to 2 years

Secondary Outcomes (2)

• overall survival

  up to 4 years

• disease free survival

  up to 4 years

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Drug: Aza, tislelizumab

Interventions

Aza, tislelizumab DRUG

combination chemotherapy for the refractory/relapsed AML

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

HBDH

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, open label, single arm clinical study

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: September 19, 2024
• Study Start: October 5, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)