EUCTR2014-001633-84-IT进行中（未招募）1 期
Phase 1b/2 Study of Carfilzomib in Combination with Dexamethasone, Mitoxantrone, PEG-asparaginase, and Vincristine (UK R3 Induction Backbone) in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 39
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. Age 18 years or younger at the time of study treatment initiation.
- •2. Subjects must have a diagnosis of relapsed (Phase 1b and 2) or refractory (Phase 1b only) ALL with = 5% blasts in the bone marrow (M2 or M3 disease), with or without extramedullary disease.
- •?- To be eligible for Phase 1b, subjects must have had 1 or more prior
- •therapeutic attempts, defined as:
- •o Early first relapse (< 36 months from original diagnosis) after
- •achieving a CR OR
- •o Relapse after achieving a CR following the first or subsequent relapse
- •(i.e., = 2 relapses) OR
- •o Failing to achieve a CR from original diagnosis after at least 1 induction attempt
- •?- To be eligible for Phase 2, subjects must have had 2 or more prior
- •therapeutic attempts and have relapsed, but not refractory disease, defined as relapse after achieving a CR following the first or subsequent relapse (i.e., = 2 relapses)
- •3. Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment.
- •4. Subjects must have a serum creatinine level that is = 1.5 × institutional upper limit of normal (ULN) according to age. If serum creatinine level is > 1.5 × ULN, the subject must have a calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) = 70 mL/min/1.73 m2.
- •5. Adequate liver function, defined as both of the following:
- •? Total bilirubin = 1.5 × institutional ULN
- •? AST and ALT = 5 × institutional ULN
- •6. Performance status: Karnofsky or Lansky scores = 50 for subjects > 16 years old or = 16 years old, respectively.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 39
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known allergy to any of the drugs used in the study. (Subjects who have had a previous allergy to PEG-asparaginase but can receive
- •Erwinia are eligible.)
- •2. Known allergy to Captisol (a cyclodextrin derivative used to solubilize
- •carfilzomib; for a complete listing of Captisol-enabled drugs, see the Ligand Pharmaceuticals, Inc. website)
- •3. Left ventricular fractional shortening < 30%
- •4. History of pancreatitis; serum amylase > 2 × the institutional ULN
- •5. Active treatment for graft-versus-host disease
- •6. Positive culture for bacteria or fungus within 14 days of the initiation of therapy
- •7. Down Syndrome
- •8. Prior therapy restrictions:
- •? -Subjects must have completed therapy with granulocyte-colony stimulating factor (G-CSF) or other myeloid growth factors at least 7 days before enrollment, or at least 14 days before enrollment, if pegylated myeloid growth factors were administered.
- •? -Subjects must have received the last dose of a non-monoclonal antibody biologic agent at least 7 days before enrollment. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be approved by the Onyx study medical monitor.
- •? -At least 3 antibody half-lives must have elapsed since the last dose of monoclonal antibody (i.e., 66 days for rituximab and 69 days for
- •epratuzumab) before subjects may enroll in the study.
- •? -Subjects must have completed any type of active immunotherapy
- •(e.g., tumor vaccines) at least 42 days before enrollment.
- •? -Subjects must not have received any other antineoplastic agents within 7 days prior to enrollment.
研究者
相似试验
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 LeukemiaEUCTR2014-001633-84-ROOnyx Therapeutics, Inc., an Amgen Inc. subsidiary144
进行中（未招募）
1 期
A Research Study of Carfilzomib in Children with Relapsed or Refractory LeukemiaRelapsed or Refractory Acute Lymphoblastic LeukemiaMedDRA version: 17.1Level: LLTClassification code 10025230Term: Lymphatic leukemiaSystem Organ Class: 100000004864EUCTR2014-001633-84-FROnyx Therapeutics, Inc.39
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 LeukemiaRelapsed or Refractory Acute Lymphoblastic LeukemiaMedDRA version: 21.0Level: LLTClassification code 10025230Term: Lymphatic leukemiaSystem Organ Class: 100000004864EUCTR2014-001633-84-PLOnyx Therapeutics, Inc., an Amgen Inc. subsidiary144
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 LeukemiaRelapsed or Refractory Acute Lymphoblastic LeukemiaMedDRA version: 21.0Level: LLTClassification code 10025230Term: Lymphatic leukemiaSystem Organ Class: 100000004864EUCTR2014-001633-84-ATOnyx Therapeutics, Inc., an Amgen Inc. subsidiary144
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 LeukemiaRelapsed or Refractory Acute Lymphoblastic LeukemiaMedDRA version: 21.0Level: LLTClassification code 10025230Term: Lymphatic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-001633-84-SEOnyx Therapeutics, Inc., an Amgen Inc. subsidiary144