EUCTR2010-021944-17-DE进行中（未招募）1 期
Randomized, Multi-centre, Phase II Trial to compare the Event-Free Survival of Clofarabine / Ara-C (ClAraC) or of FLAMSA Treatment in Patients with High Risk AML or Advanced MDS scheduled for Allogeneic Stem Cell Transplantation - ClAraC-SCT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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. Signed written informed consent
- •2. Age = 18 at the day of inclusion
- •3. Patients with high risk AML or advanced MDS (IPSS score = intermediate 2) scheduled for an allogeneic SCT from HLA-matched related or unrelated donor
- •4.Amount of blasts < 60% (bone marrow)
- •5. Patients fulfilling at least one of the following risk factors:
- •Contraindication for conventional conditioning therapy
- •Relapsed or refractory to induction therapy
- •6. Adequate renal, hepatic and cardiac functions as indicated by the following values:
- •Serum creatinine < = 1.0 mg/dL;
- •if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m2
- •Serum bilirubin < = 1.5 x upper limit of normal (ULN)
- •Aspartate transaminase (AST) / alanine transaminase (ALT) < = 2.5 x ULN
- •Alkaline phosphatase < = 5 x ULN
- •Left ventricular ejection fraction = 50 %
- •7. Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- •8. Female patients of childbearing potential must have a negative serum pregnancy test at the day of inclusion
- •9. Female patients must meet one of the following criteria:
- •For female patients >= 50 years of age at the day of inclusion: Menopause since at least 1 year
- •Female patients < 50 years of age at the day of inclusion who meet all of the following criteria:
- •- menopause since at least 1 year
- •- serum FSH levels > 40 MIU/mL
- •- serum estrogen levels < 30 pg/mL or negative estrogen test
- •6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy
- •Correct use of two reliable contraception methods from the time of screening and during the study for a minimum of 90 days after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) or of an intrauterine device (IUD) with a barrier method (diaphragm, cervical cap, Lea contraceptive, femidom or condom) or with a spermicide. In case the patient takes hormone preparations for suppression of menstruation during the period of aplasia, a suitable and effective method of contraception has to be discussed with the investigator and used by the patient
- •General sexual abstinence from the time of screening, during the study until a minimum of 90 days after the last administration of study medication
- •Having only female sexual partners
- •Monogamous relationship with sterile male partner
- •10. Male patients must meet one of the following criteria:
- •6 weeks after surgical sterilization by vasectomy
- •Correct use of two reliable contraception methods from the time of screening and during the study for a minimum of 90 days after the last administration of study medication. This includes every combination of a hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) or of an intrauterine device (IUD) with a barrier method (diaphragm, cervical cap, Lea contraceptive, femidom or condom) or with a spermicide.
- •General sexual abstinence from the time of screening, during the study until a minimum of 90 days after the last administration of study medication
- •Having only male sexual partners
- •Monogamous relationship with sterile female partner
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age
排除标准
- •1. Patients with acute promyelocytic leukemia with t(15;17)
- •2. Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
- •3. Any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea.
- •The patient must have recovered from all acute toxicities from any previous therapy
- •4. Current participation in any other clinical trial and/or participation in another clinical trial within 30 days before the trial begins (Exception: Parallel follow-up of any other trial at least 30 days after end of intervention)
- •5. Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart (heart insufficiency = NYHA II), kidney (serum creatinine > 1.5 x normal serum level), liver (bilirubin > 1.5 x normal serum level, AST / ALT, AP > 5 x normal serum level), or other organ system that may place the patient at undue risk to undergo treatment
- •6. Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- •7. Human immunodeficiency virus (HIV) positivity
- •8. Pregnant or lactating patients
- •9. Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
- •10. Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy, with the following exceptions:
- •Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed
- •Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
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