NL-OMON53153招募中不适用
A phase 1, multicenter, open-label, safety study of AG-120 or AG-221 in combination with induction therapy and consolidation therapy in patients with newly diagnosed acute myeloid leukemia with an IDH1 and/or IDH2 mutation - AG120-221-C-001
Institut de Recherches Internationales Servier (I.R.I.S)0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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. >=18 years of age
- •2. Previously untreated AML (de novo or secondary) defined according to
- •WHO criteria, excluding APL [AML with t(15;17)], with locally
- •documented IDH1 and/or IDH2 gene mutation scheduled for induction
- •therapy followed by consolidation therapy. Secondary AML is defined as
- •AML arising after MDS or another antecedent hematologic disorder (AHD) or AML
- •arising after exposure to genotoxic injury including radiation and/or
- •chemotherapy. Patients may have had previous treatment with
- •hypomethylating agents (HMAs) for MDS, provided that the last dose of
- •administration was >14 days prior to study drug initiation.
- •3. ECOG PS score of 0 to 2
- •4. Adequate hepatic function as evidenced by:
- •a. Serum total bilirubin <=1.5 × upper limit of normal (ULN) unless
- •considered due to Gilbert's disease, a gene mutation in UGT1A1 (only for
- •subjects who will be receiving AG-221), or leukemic involvement
- •following approval by the Medical Monitor
- •b. AST, ALT, and ALP <=3.0 × ULN, unless considered due to leukemic
- •involvement following approval by the study sponsor
- •5. Adequate renal function as evidenced by serum creatinine <=2.0 × ULN
- •or creatinine clearance >40 mL/min based on the Cockroft-Gault
- •glomerular filtration rate (GFR)
- •6. Agree to serial blood and bone marrow sampling
- •7. Meet any criteria necessary for the safe and proper use of the
- •induction and consolidation agents involved in this trial
- •8. Able to understand and willing to sign an informed consent form. A
- •legally authorized representative may consent on behalf of a subject
- •who is otherwise unable to provide informed consent, if acceptable to,
- •and approved by, the site's Institutional Review Board
- •(IRB)/Independent Ethics Committee (IEC)
- •9. Female subjects with reproductive potential must agree to undergo a
- •medically supervised pregnancy test prior to starting study drug. The
- •first pregnancy test will be performed at screening (within 7 days prior
- •to first study drug administration). A pregnancy test should also be
- •performed on the day of the first study drug administration and
- •confirmed negative prior to dosing as well as before dosing on Day 1 of
- •all subsequent cycles.
- •10. Female subjects with reproductive potential must have a negative
- •serum pregnancy test within 7 days prior to the start of the therapy.
- •Subjects with reproductive potential are defined as sexually mature
- •women who have not undergone a hysterectomy, bilateral oophorectomy
- •or tubal occlusion or who have not been naturally postmenopausal for at
- •least 24 consecutive months. Females of reproductive potential as well
- •as fertile men and their partners who are females of reproductive
- •potential must agree to abstain from sexual intercourse or to use one
- •highly effective form (for subjects receiving AG-221) or two highly
- •effective forms (for subjects receiving AG-120) of contraception from
- •the time of giving informed consent, during the study, and for 2 months
- •(for subjects receiving AG-221) and for 4 months (for subjects receiving
- •AG-120) following the last dose of AG-120 or AG-221 (females and
- •males). A highly effective form of contraception is defined as hormonal
- 另有 3 项未显示
排除标准
- •1. Have received prior chemotherapy for AML. Hydroxyurea is allowed prior to
- •enrollment for the control of peripheral leukemic blasts in subjects with
- •leukocytosis; hydroxyurea may be allowed on study with study sponsor approval.
- •2. Taking medications with narrow therapeutic windows listed in
- •Appendix 15.6 (for subjects taking AG-221) or Appendix 15.7 (for subjects
- •taking AG-120), unless they can be transferred to other medications prior
- •to enrolling or unless the medications can be properly monitored during
- •3. Taking known strong cytochrome P450 (CYP) 3A4 inducers or
- •inhibitors unless they can be transferred to other medications prior to
- •enrolling. For subjects taking AG-120, systemic administration of a moderate or
- •strong CYP3A4 inhibitor requires careful monitoring of the heart rate-corrected
- •QT interval (QTc) interval using Fridericia*s formula (QTcF).
- •4. Taking P-glycoprotein (P-gp) or BCRP transporter-sensitive substrate
- •medications unless they can be transferred to alternative medications within
- •>= 5 half-lives prior to administration of AG-221, or unless the
- •medications can be properly monitored during the study. There are no
- •restrictions regarding the co-administration of such medications with AG-120.
- •5. Pregnant or breast feeding
- •6. Uncontrolled active infection or uncontrolled invasive fungal infection
- •(positive blood or tissue culture). An infection controlled with an
- •approved or closely monitored antibiotic/antifungal treatment is
- •7. Prior history of malignancy, other than MDS or AML, unless the subject
- •has been free of the disease for >=1 year prior to the start of study
- •treatment. However, subjects with the following history/concurrent
- •conditions are allowed:
- •a. Basal or squamous cell carcinoma of the skin
- •b. Carcinoma in situ of the cervix
- •c. Carcinoma in situ of the breast
- •d. Incidental histologic finding of prostate cancer
- •8. Significant active cardiac disease within 6 months prior to the start of
- •study treatment, including New York Heart Association (NYHA) Class III
- •or IV congestive heart failure; myocardial infarction, unstable angina
- •and/or stroke; or LVEF <40% by echocardiogram (ECHO) or multi-gated
- •acquisition (MUGA) scan obtained within 28 days prior to the start of
- •study treatment
- •9. QTc interval >450 msec or other
- •factors that increase the risk of QT prolongation or arrhythmic events
- •(e.g., heart failure, hypokalemia, family history of long QT interval
- •syndrome). Bundle branch block and prolonged QTc interval are
- •permitted with approval of the study sponsor.
- •10. Taking medications that are known to prolong the QT interval unless
- •they can be transferred to other medications within >=5 half-lives prior to
- •dosing (If equivalent medication is not available QTc will be closely
- •11. Known infection caused by human immunodeficiency virus (HIV) or active
- •hepatitis B or C
- •12. Dysphagia, short-gut syndrome, gastroparesis, or other conditions
- •that limit the ingestion or gastrointestinal absorption of orally
- •administered drugs
- •13. Clinical symptoms suggestive of active central nervous system (CNS)
- •leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF)
- 另有 3 项未显示
研究者
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