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OncoMatch/Clinical Trials/NCT04501120

Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML

Is NCT04501120 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for relapsed/refractory acute myeloid leukaemia.

Phase 1/2RecruitingAscentage Pharma Group Inc.NCT04501120Data as of May 2026

Treatment: Lisaftoclax (APG-2575) · Reduced-dose HHT · standard-dose HHT · Azacitidine · Lisaftoclax (APG-2575) · olverembatinibThe purpose of this study is to assess the safety, pharmacokinetic profile of Lisaftoclax (APG-2575) single agent and in combination with HHT/AZA in patients with relapsed/refractory AML and related myeloid malignancies.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Excluded: BCR BCR-ABL1

t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML patients

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: allogeneic hematopoietic stem cell transplantation

Prior history of allogeneic hematopoietic stem cell transplantation

Cannot have received: adoptive cell immunotherapy

adoptive cell immunotherapy

Cannot have received: autologous hematopoietic stem cell transplantation

Exception: within 12 months

autologous hematopoietic stem cell transplantation within 12 months

Cannot have received: chemotherapy (hydroxyurea)

Exception: hydroxyurea permitted more than 24 hours before first dose

Within 14 days before the first dose of study drug, received chemotherapy (hydroxyurea is permitted more than 24 hours before the first dose of study drug)

Cannot have received: radiotherapy

Within 14 days before the first dose of study drug, received ... radiotherapy

Cannot have received: surgery

Within 14 days before the first dose of study drug, received ... surgery

Cannot have received: immunotherapy

Within 14 days before the first dose of study drug, received ... immunotherapy

Cannot have received: targeted therapy

Within 14 days before the first dose of study drug, received ... targeted therapy

Cannot have received: biological therapy

Within 14 days before the first dose of study drug, received ... biological therapy

Cannot have received: investigational treatment

Within 14 days before the first dose of study drug, received ... any investigational treatment

Lab requirements

Kidney function

adequate renal function

Liver function

adequate liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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