EUCTR2014-001303-52-IT进行中（未招募）不适用
Treatment of relapsed/refractory leukemia with intravenous administration of Dacarbazine - DTIC protocol
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •Patients aged between 18 and 65 years
- •Signed written informed consent prior to beginning protocol specific procedures according to ICH/EU/GCP and national/local laws
- •Diagnosis of refractory acute myeloid leukaemia (after 1 cycle of induction therapy and 1 salvage therapy) or relapsed acute myeloid leukemia (after 1 salvage therapy)
- •Levels of MGMT associated with leukaemic blasts (obtained from bone marrow or peripheral blood): MGMT/ß-Actin ratio (Western Blot analysis) not higher than 0.4 or MGMT activity (enzymatic determination) not exceeding 200 fM/mg protein
- •WHO performance status 0-3
- •Adequate renal (serum creatinine < 2 x the institutional ULN) and liver (total serum bilirubin < 2 x ULN; serum ALT and AST = 3 x ULN) function, unless considered due to organ leukemic involvement
- •-Left Ventricular Ejection Fraction (LVEF) >50%, as determined by echocardiogram
- •Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection
- •Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule
- •Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of study drugs (post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential)
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients aged less than 18 or more than 65 years
- •Acute promyelocytic leukaemia
- •Blast crisis of chronic myeloid leukaemia
- •AML supervening after other myeloproliferative disease
- •Previous treatment with any other experimental drug within 3 weeks prior to study entry
- •Levels of MGMT associated with leukaemic blasts (obtained from bone marrow or peripheral blood): MGMT/ß-Actin ratio (Western Blot analysis) higher than 0.4 or MGMT activity (enzymatic determination) exceeding 200 fM/mg protein
- •Inadequate renal or liver function (metabolic abnormalities > 3 times the normal upper limit)
- •Severe heart failure requiring diuretics
- •Ejection fraction < 50%
- •Uncontrolled infections
- •WHO performance status = 4
- •Severe concomitant neurological or psychiatric diseases
- •Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
研究者
相似试验
进行中（未招募）
1 期
Treatment of blood cancer with the use of a drug active against herpesvirusesChronic lymphocytic leukemiaMedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-021786-78-ATMedizinische Universität Wien
招募中
2 期
Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-BBzeta retroviral vector – A unicenter Phase I/II clinical trial [HD-CAR-1]2024-516832-82-00Universitaetsklinikum Heidelberg AöR63
招募中
3 期
Acute Lymphoblastic Leukemia treatment protocol for children and adolescentRBR-6pmfz8Sociedade Brasileira de Oncologia Pediátrica (SOBOPE)
已完成
不适用
Treatment of acute lymphoblastic leukemia (ALL) in adults age 40 - 70 years inclusive with chemotherapy including a pre-induction course for rapid tumor load reduction and prolonged maintenance chemotherapyAcute Lymphoblastic LeukemiaLymphoid leukaemiaCancerISRCTN00446029Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)55
进行中（未招募）
不适用
Traitement des leucémies primitives à plasmocytes du sujets de moins de 70 ansEUCTR2009-016607-33-FRCHU Amiens