NL-OMON55976招募中不适用
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral, covalent, menin inhibitor, in adult patients with acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) - COVALENT-101
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Read, understood, and provided written informed consent and, if applicable,
- •Health Insurance Portability and Accountability Act (HIPAA) authorization by
- •subject or legal guardian after the nature of the study has been fully
- •explained and must be willing to comply with all study requirements and
- •procedures including DLBCL tumor biopsies (Cohort 2), serial bone marrow and
- •peripheral blood sampling.
- •2. Males and females of age: >= 18 years
- •3. All subjects must have histologically or pathologically confirmed diagnosis
- •of their malignancy and/or measurable R/R disease, as follows:
- •a. Cohort 1 only: Refractory or relapsed acute leukemia defined as > 5% blasts
- •in the bone marrow or reappearance of blasts in the peripheral blood (as
- •defined by the NCCN in the NCCN Clinical Practice Guidelines in Oncology [NCCN
- •Guidelines®] for Acute Lymphoblastic Leukemia [Version 2.2021] and Acute
- •Myeloid Leukemia [Version 3.2021] ) Specific mutational statuses may be
- •required for allocation to a specific subcohort.
- •b. Cohort 2 only: Previously treated, pathologically confirmed de novo DLBCL,
- •or DLBCL transformed from previously indolent lymphoma (e.g., follicular
- •lymphoma) with documented clinical or radiological evidence of progressive or
- •persistent disease. At study entry, subjects must have measurable disease as
- •per the revised criteria for response assessment of lymphoma (Cheson, 2014).
- •c. Cohort 3 only: Measurable MM based on at least one (1) of the following:
- •i. Serum M-protein >= 0.5 g/dL by serum protein electrophoresis (SPEP) (for an
- •IgA-based myeloma, preferably by a quantitative serum IgA level)
- •ii. Urinary M-protein excretion >= 200 mg/24 hours
- •iii. Free light chain MM: Serum free light chain (sFLC) >= 10 mg/dL (100 mg/L),
- •provided serum FLC ratio is abnormal
- •iv. Of note, subjects without measurable disease in serum or urine, but with
- •plasmacytoma(s) >= 2.0 cm are eligible
- •d. Cohort 4 only: Previously treated CLL/SLL with active disease meeting any of
- •the following
- •conditions per the iwCLL 2018 criteria
- •i. Evidence of progressive marrow failure as manifested by the development of,
- •or worsening of, anemia and/or thrombocytopenia
- •ii. Massive (i.e., >= 6 cm below the left costal margin) or progressive or
- •symptomatic splenomegaly
- •iii. Massive nodes (i.e., >= 10 cm in longest diameter) or progressive or
- •symptomatic lymphadenopathy
- •iv. Progressive lymphocytosis with an increase of >= 50% over a 2-month period,
- •or lymphocyte doubling time (LDT) < 6 months. LDT can be obtained by linear
- •regression extrapolation of absolute lymphocyte counts obtained at intervals of
- •2 weeks over an observation period of 2 to 3 months; subjects with initial
- •blood lymphocyte counts < 30 × 109/L may require a longer observation period to
- •determine the LDT. Factors contributing to lymphocytosis other than CLL/SLL
- •(e.g., infections, steroid administration) should be excluded
- •v. Autoimmune complications including anemia or thrombocytopenia poorly
- •responsive to corticosteroids
- •vi. Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung,
- •vii. Disease-related symptoms as defined by any of the following:
- •a. Unintentional weight loss >= 10% within the previous 6 months
- •b. Significant fatigue (i.e., ECOG PS 2 or worse; cannot work or unable to
- 另有 1 项未显示
排除标准
- •1. Certain disease subtypes or occurrences, as follows:
- •a. Cohort 1: APL, CML in blast crisis, iEMR.
- •b. Cohort 2: PMBCL, DLBCL transformed from diseases other than indolent NHL,
- •Burkitt Lymphoma
- •c. Cohort 3: Active plasma cell leukemia, myeloma with amyloidosis, systemic
- •light chain amyloidosis
- •d. Cohort 4: Known or suspected history of Richter*s transformation
- •2. WBC count > 50,000/ µL (uncontrollable with cytoreductive therapy) (Cohort 1
- •3. Known central nervous involvement, as follows:
- •a. Cohort 1: Clinically active CNS leukemia. Previously controlled CNS leukemia
- •is acceptable, however
- •b. Cohort 2: Active CNS lymphoma or meningeal involvement
- •c. Cohort 3: Active CNS MM
- •d. Cohort 4: Active CNS leukemia
- •4. Prior menin inhibitor therapy (exept for subjects in Cohort 1).
- •5. Known positive test for human immunodeficiency virus, hepatitis C, or
- •hepatitis B surface antigen. Of note: HBV core Ab positive but HBV DNA negative
- •subjects with no prior history of reactivation with prior CD20 monoclonal
- •antibody exposure and prophylaxis would be allowed with reinstitution of
- •appropriate prophylaxis; HCV Ab positive after treatment with anti-hepatitis C
- •medications and viral load negative for at least 6 months would be eligible. If
- •the subject is known to be cytomegalovirus (CMV) IgG or CMV IgM positive, the
- •subject must be evaluated for the presence of CMV DNA by PCR. Subjects who are
- •known to be CMV IgG or CMV IgM positive but who are CMV DNA negative by PCR are
- •eligible. Antiviral prophylaxis should be considered per institutional protocol.
- •6. Subjects with a pre-existing disorder predisposing them to a serious or
- •life-threatening infection (e.g., cystic fibrosis, congenital or acquired
- •immunodeficiency, bleeding disorder, or cytopenias not related to acute
- •leukemia, DLBCL, MM, or CLL/SLL).
- •7. An active uncontrolled acute or chronic systemic fungal, bacterial, or viral
- •8. Significant cardiovascular disease including unstable angina pectoris,
- •uncontrolled hypertension or arrhythmia, history of cerebrovascular accident
- •including transient ischemic attack within 6 months prior to the first dose of
- •the study treatment, congestive heart failure (New York Heart Association
- •[NYHA] Class III or IV) related to primary cardiac disease, ischemic or severe
- •valvular heart disease, or a myocardial infarction within 6 months prior to the
- •first dose of study treatment. Additional cardiovascular exclusions include any
- •evidence of pericardial effusion or LVEF < 45% assessed by echocardiogram
- •(ECHO), multi-gated acquisition (MUGA), or local standard.
- •9. Mean QTcF or QTcB of > 470 millisecond (ms) on triplicate ECGs performed
- •within 5 minutes of each other.
- •10. Major surgery within 4 weeks prior to the first dose of study treatment.
- •Surgery requiring local/epidural anesthesia (excluding biopsies) must be
- •completed at least 72 hours before study drug administration and the subject
- •should be recovered.
- •11. Unable to swallow tablets or have gastrointestinal disease or dysfunction
- •that may interfere with oral absorption of study treatment, such as:
- •a. Chronic diarrhea or ingestion (e.g., short-gut syndrome, gastroparesis,
- •b. Cirrhosis with a Child-Pugh score of B or C.
- •c. Post gastrectomy
- 另有 1 项未显示
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