EUCTR2010-022584-35-DE进行中（未招募）不适用
Clofarabine salvage therapy in patients with relapsed or refractory AMLThe BRIDGE Trial
Dresden Universtity of Technology0 个研究点开始时间: 2010年9月28日最近更新:
适应症
相关药物
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
- •(1) Diagnosis of AML according to WHO criteria.
- •(2) Untreated relapse or refractory disease after a minimum of one standard induction therapy. Treatment of
- •relapse with leukocyte-apheresis or up to 5 days with low dose cytarabine or hydroxyurea is allowed.
- •Refractory disease is defined as =5% blasts after the second cycle of induction therapy or no reduction in
- •marrow blasts at early treatment assessment (day +15) after the first cycle of induction therapy.
- •Relapse is defined as an increase in bone marrow blast count =5%, re-appearance of blasts in the peripheral
- •blood or extramedullary disease.
- •(3) Age above 40 years.
- •(4) Have adequate renal and hepatic functions as indicated by the following laboratory 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 (see reference below*)
- •Serum bilirubin =1.5× upper limit of normal (ULN)
- •Aspartate transaminase (AST)/alanine transaminase (ALT) =2.5× ULN
- •Alkaline phosphatase =2.5× ULN
- •(5) Eligibility for intensive chemotherapy
- •(6) Patient needs to be capable to understand the clinical trial as an investigational approach to bridge the time to
- •potential allogeneic HCT, potential risks and benefits of the study.
- •(7) Signed written informed consent.
- •(8) Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to
- •enrollment.
- •(9) Male and female patients must use an effective contraceptive method during the study and for a minimum of 6
- •months after study treatment.
- •* Calculation of Creatinine Clearance by the Modification of Diet in Renal Disease equation where Predicted
- •GFR (ml/min/1.73 m2) = 186x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x
- •(1.212 if patient is black).
- •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 range 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •(1) For refractory disease, more than two prior induction chemotherapies or more than one prior salvage
- •chemotherapy containing high-dose cytarabine (cumulative dose of cytarabine = 5 g/m2).
- •(2) Second or higher relapse. Patients who received hypomethylating agents like azacytidine or decitabine as a
- •treatment of first relapse, respond and relapse later on may be included.
- •(3) Acute promyelocytic leukemia with t(15;17)(q22;q12) molecular detection or (PML/RARa).
- •(4) Central nervous system involvement (i.e. WBC = 5/µL in cerebrospinal fluid with blasts present on cytospin).
- •(5) Prior allogeneic HCT
- •(6) Autologous transplantation within 100 days prior to start of study treatment
- •(7) Use of investigational agents or anticancer therapy within 10 days before study entry with the exception of
- •hydroxyurea or low-dose cytarabine.
- •(8) 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 transplantation.
- •(9) Patients with known refractoriness to platelet support.
- •(10) 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).
- •(11) Pregnant or lactating patients.
- •(12) 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.
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