EUCTR2011-005562-38-DE进行中（未招募）1 期
A multi-center phase I/II safety and feasibility study using CliniMACS TCRa/ß and CD19 depleted stem cell grafts from haploidentical donors for haematopoietic progenitor cell transplantation in children and adults - TCRalpha/beta-Haplo2010
Miltenyi Biotec GmbH0 个研究点目标入组 60 人开始时间: 2012年5月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
入选标准
- •Adult and paediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease
- •- Acute myeloid leukemia (AML):
- •Patients with high-risk AML in CR1
- •Patients with relapsed or primary therapy-refractory AML
- •- Acute lymphoid leukemia (ALL):
- •Patients with high-risk ALL in CR1
- •Patients with relapsed or primary refractory ALL
- •- Hodgkin’s disease: Patients with relapsed or primary refractory Hodgkin’s disease
- •- Non-Hodgkin’s lymphoma: Patients with relapsed or primary refractory Non-Hodgkin’s lymphoma
- •- Myelodysplastic Syndrome (MDS)/ Myeloproliferative Syndrome (MPS): Patients with refractory MDS/MPS
- •- Multiple myeloma (MM): Patients with relapsed or refractory multiple myeloma
- •Adult and paediatric patients with non-hematological malignancies without curative treatment option, mainly
- •- Neuroblastoma: Patients with relapsed metastatic nmyc-negative or -positive or local nmyc-positive neuroblastoma
- •- Soft tissue sarcoma:
- •relapsed metastatic soft tissue sarcoma (rhabdomyosarcoma, Ewing sarcoma, peripheral neuroectodermal tumor)
- •soft tissue sarcoma with primary bone metastases or bone involvement in patients older than 10 years
- •Adult and paediatric patients with the following non-malignant diseases with HSCT as curative treatment option
- • Hematologic diseases, acquired and congenital
- • Severe aplastic anemia (patients not responding to immune suppression)
- • Paroxysmal nocturnal haemoglobinuria (PNH)
- • Haemaphagocytic lymphohistiocytosis (HLH)
- • Congenital immunodeficiencies
- • Severe combined immune deficiency (SCID) and related diseases
- • Chediak Higashi syndrome
- • Congenital metabolic disorders
- • Malignant osteopetrosis
- • Lysosomal storage disorders (mucopolysacharidoses, leukodystrophies, glycoprotein disorders)
- •Additional patient inclusion criteria:
- •No HLA-identical stem cell donor available as determined by high-resolution typing (maximum of 1 antigen or allelic mismatch are acceptable [9/10 match]), but eligible haploidentical donor with >1 antigenic or allelic mismatch (9/10-match) identified and at call; Exception: Haploidentical HSCT is medically indicated even if an HLA-identical donor is available and decision for haplo-identical HSCT has been made according to hospital routine prior to inclusion of the patient into this study.
- •Patients aged =8 weeks to =65 years
- •Male or female without childbearing potential or using medically adequate contraception
- •Karnofsky (patients >16 years)/Lansky (patients =16 years) index >60%
- •Patient in good clinical condition without concomitant diseases significantly increasing the risk of transplantation, see exclusion criteria
- •Adult patients without active infections at the time of transplantation
- •Pediatric patients without uncontrollable, progressive infections at the time of transplantation
- •Are the trial subjects under 18? yes
- •Number of su
排除标准
- •Main exclusion criteria for patients:
- •Age >65 years or <8 weeks
- •Patients with progressive disease prior hematopoietic cell transplantation (HCT)
- •<3 months after preceding HCT
- •History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukencephalopathy, active CNS infection)
- •Note: For patients with HLH or Malignant Osteopetrosis or other patients with heavy pretreatment with irradiation or intrathecal chemotherapy pre-transplant CNS MRI and neurological consultation are mandatory.
- •Fungal infections with radiological and clinical progression
- •Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L
- •Chronic active viral hepatitis
- •Adult patients: Ejection fraction <40% on echocardiography; pediatric patients: Ejection fraction <40% or shortening fraction <25% on echocardiography
- •Patients with > grade II hypertension by CommonToxicity Criteria (CTC)
- •Creatinine clearance below threshold defined for stem cell transplantation according to local clinical standard
- •Respiratory failure necessitating supplemental oxygen
- •HIV infection
- •Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter.
- •Note: Women of childbearing potential must have a negative serum pregnancy test at study entry.
- •Concurrent severe or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which by assessment of the treating physician could compromise participation in the study
- •Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
- •Patients unwilling or unable to comply with the protocol or unable to give informed consent
- •Treatment with any investigational product within 4 weeks prior to study treatment (transfusion of the IMP)
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