EUCTR2009-012437-30-SE进行中（未招募）不适用
Clofarabine based remission induction followed by haploidentical stem celltransplantation in children with refractory hematological malignancies
Skånes University Hospital0 个研究点开始时间: 2010年4月16日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •3.1 Inclusion Criteria
- •I. Target population
- •1. Refractory acute lymphoblastic leukemia
- •a. Chemoresistant isolated or combined bone marrow relapse
- •Relapse after during/after conventional treatment
- •Relapse >6 months after allogeneic stem cell transplantation
- •b. Primary induction failure
- •c. Isolated extramedullary relapse after previous HSCT (>6
- •2. Refractory acute myeloblastic leukemia including sAML
- •a. Chemoresistant relapse
- •Relapse after during/after conventional treatment
- •Relapse >6 months after allogeneic stem cell
- •transplantation[1]
- •b. Primary induction failure
- •II. Inclusion criteria to start induction treatment with multidrug regimen
- •1. Age > 1 and =21 years
- •2. Patients with previous HCST = 6 m[1]
- •3. Provide signed written informed consent patients’, and patients’
- •parents/guardians
- •a. Older children should be capable of understanding the
- •investigational nature, potential risks and benefits of the study,
- •and able to provide valid informed consent as well.
- •4. Cardiac output SF =25%
- •5. Have adequate renal and hepatic functions as indicated by the
- •following laboratory values:
- •Calculated creatinine clearance =90 ml/min/1.73 m2 as
- •calculated by the Schwartz formula for estimated glomerular
- •filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height
- •(cm)/serum creatinine (mg/dl). k is a proportionality constant
- •which varies with age and is a function of urinary creatinine
- •excretion per unit of body size; 0.45 up to 12 months of age;
- •0.55 children and adolescent girls; and 0.70 adolescent boys.
- •Serum bilirubin =1.5 × upper limit of normal (ULN)
- •Aspartate transaminase (AST)/alanine transaminase (ALT) =2.5 × ULN
- •Alkaline phosphatase = 2.5 × ULN
- •6. Performance score of =70% (Lansky or Karnofsky)
- •7. A suitable haploidentical family member available for stem cell
- •donation, > 18 years of age, fulfilling institutional criteria for blood
- •and marrow donation.
- •8. Male and female patients must use an effective contraceptive
- •method during the study and for a minimum of 6 months after study
- •III. Inclusion criteria to proceed to transplant after induction
- •1. Cardiac output SF =25%
- •2. Have adequate renal and hepatic functions as indicated by the
- •following laboratory values:
- •Calculated creatinine clearance =90 ml/min/1.73 m2 as
- •calculated by the Schwartz formula for estimated glomerular
- •filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height
- •(cm)/serum creatinine (mg/dl).
- •k is a proportionality constant which varies with age and is a
- 另有 19 项未显示
排除标准
- •3.2 Exclusion Criteria
- •1. Current concomitant chemotherapy, radiation therapy, or
- •immunotherapy other than as specified in the protocol.
- •2. Use of investigational agents within 30 days or 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.
- •3. Have any other severe concurrent disease, or have a history of
- •serious organ dysfunction or disease involving the heart, kidney,
- •liver, or other organ system that may place the patient at undue risk
- •to undergo treatment.
- •4. 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).
- •5. Pregnant or lactating patients.
- •6. Any significant concurrent malignant disease, illness, or psychiatric
- •disorder that would compromise patient safety or compliance,
- •interfere with consent, study participation, follow up, or
- •interpretation of study results.
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