EUCTR2011-004742-18-PL进行中（未招募）不适用
Multicenter, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100µg/kg XM22 in 21 Children with Ewing Family of Tumors or RhabdomyosarcomaP/0028/2013
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merckle GmbH
- 入组人数
- 21
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. Male or female children and adolescents aged 2 to <18 years
- •2. Written informed consent provided by parent(s)/legal
- •representative(s) of the pediatric patient and patient's assent if
- •appropriate, before screening procedures are initiated
- •3. Able to understand and/or follow study instructions alone or with parental assistance
- •4. Diagnosed with the Ewing family of tumors or rhabdomyosarcoma
- •5. Scheduled to receive 1 of the following chemotherapy regimens
- •(inpatient or outpatient)
- •For the Ewing family of tumors:
- •- vincristine/ifosfamide/doxorubicin/etoposide (VIDE); concomitant treatment with sodium 2-mercaptoethane sulfonate (MESNA) according to local standards
- •- vincristine/doxorubicin/cyclophosphamide alternating with
- •ifosfamide/etoposide (VDC/IE); concomitant treatment with MESNA according to local standards
- •For rhabdomyosarcoma:
- •- vincristine/actinomycin/cyclophosphamide (VAC); concomitant treatment with MESNA according to local standards
- •- vincristine/doxorubicin/cyclophosphamide alternating with
- •ifosfamide/etoposide (VDC/IE); concomitant treatment with MESNA according to local standards
- •-ifosfamide, vincristine and actinomycin D (IVA); concomitant treatment with MESNA according to local
- •6. Body weight =15 kg for the 2 highest age strata and =12.5 kg for patients in the lowest age stratum
- •8. White blood cell (WBC) count >2.5 x 10(9)/L, absolute neutrophil count (ANC) =1.5 x 10(9)/L, and platelet count =100 x 10(9)/L (at screening and prior to CTX).
- •9. For patients aged =12 years, Eastern Cooperative Oncology Group (ECOG) performance status =2
- •10. Fertile patients (male or female) must use highly reliable
- •contraceptive measures (i.e. two of the following: oral contraception, implants, injections, barrier contraception, and intrauterine device, or vasectomized/sterilized partners, or sexual abstinence). For purposes of this study, a fertile female patient is any female patient who has experienced menarche and who has not undergone tubal ligation.
- •11. Female patients who have attained menarche must have a negative urine pregnancy test at the screening visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 21
- •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. Previous exposure to filgrastim, pegfilgrastim or lenograstim or
- •other G-CSFs in clinical development within 6 months prior to the XM22 administration
- •2. Known hypersensitivity to filgrastim, pegfilgrastim or lenograstim or any other G-CSF in clinical development
- •3. History of congenital neutropenia or cyclic neutropenia
- •4. Any illness or condition that in the opinion of the Investigator may affect the safety of the patient or the evaluation of any study endpoint
- •5. Pregnant or nursing women
- •6. Fertile patients who do not agree to use highly reliable contraceptive measures during the entire duration of the study
- •7. Prior bone marrow or stem cell transplant, or prior radiation to =25% of bone marrow (eg, whole pelvic radiation) for any reason, or any therapeutic radiation within the 3 weeks prior to the XM22 dose
- •8. Ongoing active infection or history of infectious disease within 2
- •weeks prior to the screening visit
- •9. Treatment with lithium at screening or planned during the study.
研究者
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