EUCTR2014-001633-84-PL进行中（未招募）1 期
Phase 1b/2 Study of Carfilzomib in Combination with Induction Chemotherapy in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia
Onyx Therapeutics, Inc., an Amgen Inc. subsidiary0 个研究点目标入组 144 人开始时间: 2021年2月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
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
- •110 Subject's legally acceptable representative has provided informed
- •consent when the subject is legally too young to provide informed
- •consent and the subject has provided written assent based on local
- •regulations and/or guidelines prior to any study-specific
- •activities/procedures being initiated, except for standard of care local
- •testing as permitted per Section 21.3.
- •111 Age greater than or equal to 1 month to less than 21 years. Subjects
- •greater than or equal to 18 years must have had their original diagnosis
- •at less than 18 years of age.
- •112 Subjects must be diagnosed with relapsed or refractory relapsed
- •113 Subjects must have a documented first remission, less than 5%
- •blasts in the bone marrow (M1 bone marrow) and no evidence of
- •extramedullary disease.
- •114 T-cell ALL with bone marrow relapse (defined as greater than or
- •equal to 5% leukemia blasts in bone marrow) or refractory relapse with
- •or without extramedullary disease.
- •B-cell ALL with bone marrow relapse or refractory relapse (defined as
- •greater than or equal to 5% leukemia blasts in bone marrow) after
- •having received a targeted B-cell immune therapy (eg, blinatumomab,
- •inotuzumab, or a CAR-T therapy) with or without extramedullary
- •115 Adequate liver function: bilirubin less than or equal to 1.5 x upper
- •limit of normal (ULN), alanine aminotransferase (ALT) less than or equal
- •to 5 x ULN.
- •116 Adequate renal function: serum creatinine less than or equal to 1.5 x
- •ULN or glomerular filtration rate (GFR) greater than or equal to 70
- •mL/min/1.73 m2; or for children less than 2 years of age, greater than
- •or equal to 50 mL/min/1.73 m2.
- •117 Adequate cardiac function: shortening fraction greater than or equal
- •to 30% or ejection fraction greater than or equal to 50%.
- •118 Karnofsky (subjects greater than or equal to 16 years of age) or
- •Lansky (subjects 12 months to less than 16 years of age) performance
- •status greater than or equal to 50%.
- •119 Subjects must have fully recovered from the acute toxic effects of all
- •previous chemotherapy, immunotherapy, or radiotherapy treatment
- •before enrolment (for example: recovery from gastrointestinal toxicity
- •may occur more rapidly than less reversible organ toxicities such as
- •sinusoidal obstruction syndrome or non-infectious pneumonitis, for
- •serious prior toxicities recommend discussion with Amgen medical
- •120 Life expectancy of greater than 6 weeks per investigator`s
- •judgment at time of screening
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 144
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •211 Prior treatment with carfilzomib.
- •214 Intolerance, hypersensitivity, or inability to receive any of the
- •chemotherapy components of the VXLD regimen. An exception is allowed
- •for allergy to asparaginase products if Erwinia asparaginase is unable to
- •be administered.
- •215 Autologous HSCT within 6 weeks prior to start of study treatment.
- •216 Allogeneic HSCT within 3 months prior to start of study treatment.
- •217 Active GVHD requiring systemic immune suppression.
- •218 < 30 days from discontinuation of immune suppressive therapy
- •administered for the treatment of acute or chronic GVHD.
- •219 Isolated extramedullary relapse.
- •220 Positive bacterial or fungal infection within 14 days of enrolment
- •(except for documented line infection, line has been removed, and blood
- •culture after line removal is negative for 5 days prior to first dose of
- •induction therapy). Antibiotics may be administered for prophylaxis as
- •per institutional standards up to and after enrollment.
- •221 Subjects with < 3 antibody half-lives since the last dose of
- •monoclonal antibody, prior to first dose of investigational product must
- •be discussed with the Amgen medical monitor and may be allowed to
- •enroll based on extent of disease or evidence of rapidly rising peripheral
- •or bone marrow blast counts.
- •222 Cell-based immunotherapy within 42 days prior to first dose of
- •investigational product. If the Amgen medical monitor agrees, an
- •exception may be granted to the 42-day requirement for subjects with
- •rapidly rising peripheral or bone marrow blast counts.
- •223 Down's syndrome.
- •224 Presence of another active cancer.
- •225 History of grade greater than or equal to 2 pancreatitis within 6
- •months to screening
- •226 Unresolved toxicities from prior anticancer therapy, defined as not
- •having resolved to CTCAE version 4.03 grade 1 or to levels dictated in
- •the eligibility criteria apart from alopecia or toxicities from prior
- •anticancer therapy that are considered irreversible and do not trigger
- •another exclusion criterion (defined as having been present and stable
- •for greater than 4 weeks)
- •227 Antitumor therapy within 7 days of day 1 of induction. Exception:
- •hydroxyurea to control peripheral blood leukemic cell counts is allowed
- •until start of investigational product.
- •228 Active viral infection, including but not limited to CMV, Hepatitis B
- •with positive serum hepatitis surface antigen or hepatitis B DNA, HIV,
- •Hepatitis C with detectable hepatitis C RNA. Subjects who have
- •previously received a stem cell transplant must be screened for CMV
- •infection, unless both subject and donor are known to be CMV negative.
- •229 Currently receiving treatment in another investigational device or
- •product study, or less than 14 days since ending treatment on another
- •investigational device or product study.
- •230 Uncontrolled arrhythmias or screening ECG with corrected QTc >
- •231 History or evidence of any other clinically significant disorder,
- •condition or disease that, in the opinion of the investigator or Amgen
- •physician, if consulted, would pose a risk to subject safety or interfere
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