Phase 2 Trial of BN104 as Post-HSCT Maintenance in Acute Leukemia

Korábbi kezelés

• ≥ grade 2 acute GVHD or ≥ grade 3 chronic GVHD which requiring systemic therapy.

Más betegség

• Complicated with active and uncontrolled infections.
• Activation of hepatitis B, hepatitis C, or human immunodeficiency virus.
• History of other malignancies which needed systemic treatment (excluding those in stable remission without maintenance therapy).
• Any gastrointestinal condition that may interfere with oral drug intake or absorption (e.g., dysphagia, gastroparesis, uncontrolled chronic diarrhea, intestinal graft versus host disease.
• Hypersensitivity to BN104.

Laborértékek

• Cardiac disease as followings: a. inherited long QT syndrome. b. Congestive heart failure with NYHA ≥ grade 2.
• Have received other maintenance therapies (e.g., hypomethylating agents, targetd drugs such as Bcl-2 inhibitors, FLT3 inhibitors, IDH1/2 inhibitors, interferon, interleukin-2, donor lymphocyte infusion and chemotherapy).

Egyéb

• Activation of virus, (e.g., CMV viremia with CMV DNA copies > 400 copies/ml, EBV viremia with EBV DNA copies > 400 copies/ml, and proof of activation of adenovirus and Human Parvovirus B19 ).
• Pregnancy, breastfeeding

• Male or female patients.
• Adult and adolescent patients aged ≥12 years who must weight ≥35 kg.
• Diagnosed with acute myeloid leuekmia, acute lymphoblastic leukemia or ambiguous acute leukemia according to the World Health Organization classification of hematologic neoplams (WHO 2022).
• Intermediate or high risk accroding to the ELN risk stratification.
• Harboring one of the following genetic aberrations: a. somatic NPM1 mutation (without FLT3-ITD/TKD co-mutations); b. KMT2A rearrangement/KMT2A-PTD; c. NUP98 rearrangement; d. other genetic alterations dependent on menin-KMT2A.
• Received allogenic hematopoietic stem cell transplantation within 30-180 days at the initiation of BN104 maintenance therapy.
• Achieved full donor chimerism and hematologic recovery, with acute neuthrophil count (ANC) ≥1.0×10⁹/L, platelets ≥75×10⁹/L (no red blood cells /platelets transfusion within 7 days, no G-CSF or GM-CSF within 72 hours).
• Complete hematological remission (CHR) after first allo-SCT. CHR must be confirmed by bone marrow analysis within 14 days before entering the study (CHR criteria are: "< 5% marrow blasts, no peripheral blasts, blood platelet count > 75×10⁹/L, WBC count > 3.5 G/L, ANC ≥ 1.0×10⁹/L).
• No extramedullary leukemia.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
• Adequate organ function
• Provided informed consent by all patients and the guardians ( aged 12-17 years).
• Written informed consent.
• ECOG ≥ 2.