EUCTR2020-005461-14-FI进行中（未招募）1 期
PHASE II STUDY OF AZACITIDINE IN COMBINATION WITH LOW DOSE INTENSITY VENETOCLAX IN PATIENTS WITH ACUTE MYELOID LEUKEMIAINCLUDING COMPREHENSIVE EXPLORATORY AML PROFILING AND EVALUATION OF EX VIVO DRUG SENSITIVITY AND RESISTANCE SCREENING - NAMLG-001 LD-VenEx
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 117
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent.
- •2. Patients who present with one of the following (except acute promyelocytic leukemia).
- •a. De novo or secondary AML unfit for standard induction therapy (see below).
- •b. Relapsed/refractory AML after at least 1 line of prior therapies (see below).
- •3. Written informed consent to participate in the exploratory research program including biobanking, AML profiling, and ex vivo drug sensitivity testing to assess venetoclax and other drug sensitivities.
- •a. All patients are treated with azacitidine+venetoclax irrespective of the ex vivo screening results.
- •4. ECOG Performance status = 2 for patients = 75 years of age OR = 3 for patients = 18 to 74 years of age.
- •5. Leukocyte count < 25 x10E9/l. Hydroxyurea use is permitted to meet this criterion.
- •6. Adequate renal function as demonstrated by a calculated creatinine clearance = 30 mL/min; determined by the Cockcroft Gault formula.
- •7. Adequate liver function as demonstrated by
- •a. alanine aminotransferase (ALT) = 4.0 × ULN.
- •b. bilirubin = 1.5 × ULN.
- •8. Specific inclusion criteria for elderly/unfit AML patients:
- •a. = 70 years of age
- •b. = 18 to 69 years of age and ineligible for intensive chemotherapy meeting at least one of the following criteria:
- •Clinically significant comorbidities, as reflected by at least 1 of the following criteria:
- •o Left ventricular ejection fraction (LVEF) < 50%.
- •o Lung diffusion capacity for carbon monoxide (DLCO) = 65% of expected.
- •o Forced expiratory volume in 1 second (FEV1) = 65% of expected.
- •o Chronic stable angina or congestive heart failure controlled with medication.
- •o Alanine aminotransferase (ALT) 3.0-4.0 × ULN.
- •Other contraindication(s) to anthracycline therapy (must be documented).
- •Adverse risk genetics (ELN criteria) associated with poor outcome with standard chemotherapy.
- •Patient declines intensive chemotherapy.
- •sAML after previous disease modifying treatment (i.e. HMA/induction chemotherapy and/or allogeneic stem cell transplantation) of clonal myeloid diseases such as MDS, MDS/MPN, or MPN.
- •9. Specific inclusion criteria for relapsed AML patients:
- •a. = 55 years of age with non-CBF AML relapse
- •b. = 18 of age and meeting at least one of the following criteria:
- •Not candidate for intensive chemotherapy (see criterion 8.)
- •Relapse after chemotherapy, or monotherapy with HMA, or allogeneic stem cell transplantation. (note: patients with 4th or higher relapse are excluded).
- •Patient declines intensive chemotherapy.
- •10. Specific inclusion criteria for refractory AML patients:
- •The patients who fail to achieve a complete or partial remission after previous monotherapy with HMA or induction chemotherapy (at least 1 cycle of chemotherapy containing cytarabine or clofarabine, in combination with a topoisomerase II inhibitor (e.g. anthracycline or mitoxantrone).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 53
排除标准
- •1.Acute promyelocytic leukemia (APL).
- •2. Patients with 4th or higher AML relapse.
- •3. The leukemic cell content (blast percentage) in bone marrow/peripheral blood (depending which is used for drug sensitivity testing) is < 10 %.
- •4. ECOG >3 (see also inclusion criteria 4).
- •5. Prior venetoclax treatment for myeloid malignancy.
- •6. Known CNS involvement with AML (note: CSF or radiological investigations are not required without clinical suspicion).
- •7. Known HIV infection or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection that is not controlled with antiviral medication with the definition hereof at the discretion of the investigator.
- •8. Cardiovascular disability status of New York Heart Association Class = 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in palpitations, fatigue, dyspnea, or anginal pain.
- •9. Evidence of clinically significant condition(s), which at the investigator's discretion would adversely affect the patient's participation in this study (including but not limited to):
- •a. Chronic respiratory disease that requires continuous oxygen use.
- •b. Systemic uncontrolled infection requiring therapy (viral, bacterial or fungal).
- •c. Malabsorption syndrome or other condition that precludes enteral route of administration.
- •d. Uncontrolled GVHD.
- •10. Previous malignancies with the exception of previous malignancy treated successfully with curative intent and indolent/smoldering malignancies (defined at the investigator's discretion).
- •11. Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment).
- •12. Fertile men or women of childbearing potential unless:
- •a. Surgically sterile or = 2 years after the onset of menopause.
- •b. Willing to use two methods of reliable contraception including one highly effective contraceptive method (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 12 months after the end of study treatment.
- •13. Known hypersensitivity to Venetoclax and Azacitidine.
研究者
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