OncoMatch/Clinical Trials/NCT06746519
BN104 in Combination With Chemotherapy or Targeted Agents for Acute Myeloid Leukemia
Is NCT06746519 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine for acute myeloid leukemia.
Treatment: BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine — The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with acute myeloblastic leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: KMT2A (MLL) rearrangement
Required: NPM1 mutation
Required: NUP98 rearrangement
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: menin inhibitor — monotherapy
patients with relapsed/refractory AML who have been previously treated with menin inhibitor monotherapy (Group C)
Must have received: anti-leukemia therapy
previous failed treatment with menin inhibitors is required (Group C)
Cannot have received: anti-leukemia therapy
Exception: hydroxyurea or leukocyte monocloning for control of white blood cell count, all-trans retinoic acid for initial suspicion of acute promyelocytic leukemia, or nondemethylating medications for MDS
have received prior anti-leukemia therapy (for patients in Groups A and B), except for the following: use of hydroxyurea or leukocyte monocloning for control of white blood cell count, or treatment with all-trans retinoic acid due to initial suspicion of acute promyelocytic leukemia, or use of nondemethylating medications for the treatment of MDS
Cannot have received: menin inhibitor
pre-existing treatment with targeted menin (for Group A and B patients)
Cannot have received: chemotherapy, radiotherapy, hormonal therapy, targeted therapy, or immunotherapy
prior anti-leukemia therapy, including chemotherapy, radiotherapy, hormonal therapy, targeted therapy, or immunotherapy, administered less than 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study treatment (Group C)
Cannot have received: autologous hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation or CAR-T therapy within 60 days prior to the start of study treatment, or have not recovered from toxicity associated with ASCT or CAR-T therapy
Cannot have received: allogeneic hematopoietic stem cell transplantation
allogeneic HSCT within 100 days prior to the start of study treatment, or if the patient still has a combination of active acute and chronic graft-versus-host disease, or if the patient still requires immunosuppressive therapy
Lab requirements
Kidney function
creatinine clearance ≥ 45 ml/min (if <45 ml/min, allowed if creatinine ≤ 130 µmol/L); for Group B <75 years, creatinine clearance ≥ 30 ml/min allowed
Liver function
ALT and AST ≤ 2.5 x ULN; total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease); in Phase II, ALT/AST ≤ 5 x ULN if due to leukemia invasion; for Group B <75 years, total bilirubin ≤ 3 x ULN allowed
Cardiac function
left ventricular ejection fraction ≥ 45%; for Group B <75 years, LVEF < 50% allowed
adequate hepatic, renal, and cardiac function, as defined:Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal range (ULN);Total bilirubin ≤ 1.5 x ULN* and in patients with Gilbert disease, total bilirubin ≤ 3 x ULN;Creatinine clearance ≥ 45 ml/min* as estimated by the Cockcroft-Gault formula (if <45 ml/min, enrollment is allowed if creatinine ≤ 130 µmol/L); Left ventricular ejection fraction ≥ 45%*; Note: In Phase II studies, ALT or AST may be relaxed to ≤5 x ULN if the investigator assesses that the elevated ALT or AST is due to leukemia invasion of the liver;For patients <75 years of age enrolled in Group B, total bilirubin ≤ 3 × ULN, creatinine clearance ≥ 30 ml/min, or left ventricular ejection fraction < 50% are allowed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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