EUCTR2013-003604-39-PL进行中（未招募）1 期
Clinical phase II trial to describe the safety and efficacy of Treosulfan-based conditioning therapy prior to allogeneic haematopoietic stem cell transplantation in paediatric patients with haematological malignancies - Treosulfan-based conditioning in paediatric patients with haematological malignancies
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- medac GmbH
- 入组人数
- 70
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. Haematologic malignant disease i.e. ALL, AML, MDS or JMML, indicated for allo-HSCT.
- •2.Indication for first allo-HSCT or second allo-HSCT due to disease relapse, graft failure or secondary malignancy after previous HSCT.
- •3. Available matched sibling donor (MSD), matched family donor (MFD) or matched unrelated donor (MUD). For bone marrow (BM) and peripheral blood (PB) match is defined as 9/10 or 10/10 allele match after four digit typing in human leucocyte antigen (HLA)-A, B, C, DRB1 and DQB1 antigens.
- •4. Patients with ALL or AML in complete morphologic remission (blast counts <5% in BM) and patients with MDS or JMML with blast counts < 20% in BM at study entry.
- •5. Age at time of registration from 28 days to less than 18 years of age.
- •6. Lansky (patients aged <16 years) or Karnofsky (patients aged = 16 years) performance score of at least 70%.
- •7. Written informed consent of the parents/ legal guardians and patient assent/consent according to national regulations.
- •8. Females of child-bearing potential or male patients’ partners with child-bearing potential must use a highly effective method of contraception (pearl index < 1%) such as complete sexual abstinence, combined oral contraceptive, hormone intrauterine contraceptive device (IUCD), vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients or male partners during the study and at least 6 months thereafter.
- •9. Negative pregnancy test for females of child-bearing potential.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 70
- •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. Third or later allo-HSCT.
- •2. HSCT from haploidentical or umbilical cord blood donor.
- •3. Concomitant involvement of central nervous system (CNS)
- •e.g. presence of the leukaemic blasts in the cerebrospinal fluid (CSF) at study entry.
- •4. Treatment with cytotoxic drugs within 10 days prior to day 6.
- •5. Obese paediatric patients with body mass index: weight (kg)/[height (m)]² > 30 kg/m².
- •6. Concomitant solid tumours (e.g. neuroblastoma, peripheral neuroectodermal tumour [PNET], Ewing sarcoma)
- •7. Fanconi anaemia and other deoxyribonucleic acid (DNA) breakage repair disorders; secondary leukaemia developed from the Fanconi anaemia or other DNA breakage repair disorders
- •8. Impaired liver function indicated by Bilirubin > three times the upper limit of normal (ULN), or aspartate
- •aminotransferase/alanine aminotransferase (AST/ALT) > ten times ULN, or clinical significant coagulopathy, or
- •active infectious hepatitis with clinical evidence.
- •9. Impaired renal function indicated by estimated glomerular filtration rate ([GFR], according to the Schwartz formula) < 60 mL/min/1,73m2.
- •10. Impaired cardiac function: severe cardiac insufficiency indicated by left ventricle ejection fraction (LVEF) =35 %.
- •11. Requirement for supplementary continuous oxygen.
- •12. Severe active infection requiring deferral of conditioning.
- •13. Human immunodeficiency virus (HIV) positivity.
- •14. Known pregnancy, breast feeding.
- •15. Known hypersensitivity to Treosulfan and/or Fludarabine.
研究者
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