NL-OMON56393尚未招募2 期
Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia - 20140106 - phase 2
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Amgen
- 入组人数
- 1
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
- 0 至 64（—）
入选标准
- •1. Age 21 years or younger at the time of initial ALL diagnosis and age > 1
- •year at the time of study treatment initiation. 2. Subjects must have a
- •diagnosis of ALL with >= 5% blasts in the bone marrow (M2 or M3 disease), with
- •or without extramedullary disease. • To be eligible, 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 (B-ALL) or first relapse
- •any time following the original diagnosis after achieving a CR (T-ALL) 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 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, except in the presence of Gilbert syndrome. For
- •those with hyperbilirubinemia due to Gilbert syndrome, subjects are only
- •eligible if they have a direct bilirubin . 1.5 ~ institutional ULN. • ALT <= 5
- •× institutional ULN 6. Performance status: Karnofsky or Lansky scores >= 50 for
- •subjects > 16 years old or <= 16 years old, respectively. 7. Females of
- •childbearing potential (FCBP) must have a negative serum or urine pregnancy
- •test within 48 hours prior to study treatment initiation. 8. Females of
- •childbearing potential and male subjects who are sexually active with a FCBP
- •must agree to use a highly effective method of contraception plus a male condom
- •during the study and for 6 months following the last dose of study treatment.
- •The methods of contraception are defined in the ICF. Where required by local
- •laws, regulations, and/or guidelines, additional countryspecific requirements
- •are outlined in a country-specific protocol addendum. 9. Subjects must provide
- •written informed consent and pediatric assent in accordance with federal,
- •local, and institutional laws and regulations. Phase 2: 1. 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 of the protocol. 2. Age >= 1
- •month to <= 21 years. Subjects >= 18 years must have had their original diagnosis
- •at < 18 years of age 3. Subjects must be diagnosed with relapsed or refractory
- •relapsed ALL 4. Subjects must have a documented first remission, < 5% blasts in
- •the bone marrow (M1 bone marrow) and no evidence of extramedullary disease. 5.
- •T-cell ALL with bone marrow relapse (defined as >= 5% leukemia blasts in bone
- •marrow) or refractory relapse with or without extramedullary disease. OR B-cell
- •ALL with bone marrow relapse or refractory relapse (defined as >= 5% leukemia
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) 3. Left ventricular fractional shortening < 30% 4. History of >=
- •Grade 2 pancreatitis 5. Active graft-versus-host disease requiring systemic
- •treatment 6. Positive culture for or other clinical evidence of infection with
- •bacteria or fungus within 14 days of the initiation of study treatment 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 study treatment initiation, or at least 14 days
- •before study treatment initiation, 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 study treatment initiation. For
- •agents that have known adverse events (AEs) occurring beyond 7 days after the
- •last administration, this period must be extended beyond the time during which
- •AEs are known to occur, and the Sponsor study medical monitor should be
- •contacted. • At least 3 antibody half-lives must have elapsed since the last
- •dose of monoclonal antibody (e.g., 66 days for rituximab and 69 days for
- •epratuzumab) before subjects may initiate study treatment. • Subjects must have
- •completed any type of active immunotherapy (e.g., tumor vaccines) at least 42
- •days before study treatment initiation. • Subjects must not have received other
- •antineoplastic agents with therapeutic intent, excluding hydroxyurea and
- •antimetabolites administered as part of maintenance chemotherapy, within 7 days
- •prior to study treatment initiation. 9. Females who are pregnant and/or
- •breastfeeding. Phase 2: 1. Prior treatment with carfilzomib. 4. Intolerance,
- •hypersensitivity, or inability to receive any of the chemotherapy components of
- •the VXLD regimen (or acceptable substitutes as listed in the protocol). An
- •exception is allowed for allergy to asparaginase products if Erwinia
- •asparaginase is unable to be administered. 5. Autologous HSCT within 6 weeks
- •prior to start of study treatment. 6. Allogeneic HSCT within 3 months prior to
- •start of study treatment. Please see protocol (section 21.2) for additional
- •phase 2 exclusion criteria
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