EUCTR2004-001853-27-AT进行中（未招募）不适用
A Phase II, Open-Label Study of Clofarabine in Paediatric Patients with Refractory / Relapsed Acute Lymphoblastic Leukaemia - BIOV-111
Bioenvision Limited0 个研究点目标入组 100 人开始时间: 2005年9月14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
- 入组人数
- 100
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
- •The trial will recruit patients who have failed to achieve response by standard first line therapy or following first relapse, fail to achieve response by standard relapse therapy. Children who have received an allogeneic progenitor cell transplant, must be at least 6-months post transplant. For Inclusion/Exclusion criteria, a ‘prior regimen’ is defined as including one or more of the following: Induction, Consolidation and Maintenance therapies. Patients must meet all of the following criteria for admission in the study.
- •1.Have a diagnosis of ALL
- •2.Be =21 years old at time of initial diagnosis.
- •3.i. Patients with primary, refractory ALL must have an M3 marrow at the end of conventional induction chemotherapy or have an M2 or M3 marrow at the end of no less than 2 prior regimen
- •ii Patients with first relapse ALL failing to achieve response following conventional therapy: M3 marrow following re-induction or M2 or M3 following no less than 2 prior regimen
- •iii Patients with 2 or more relapses of ALL who have received an allogeneic progenitor cell transplant, must:
- •a.be at least 6-months post transplant
- •b.have good organ function
- •c.be stable with no major complications
- •4.Must not be eligible for therapy of higher curative potential. Where an alternative therapy has been shown to prolong survival in an analagous population, this should be offered to the patient prior to discussing this study.
- •5.Have a Karnofsky Performance Status (KPS) of =50 or Lansky Performance Scale of =30 .
- •6.Provide signed, written informed consent from parent or guardian or young adult patients.
- •7.Be able to comply with study procedures and follow-up examinations.
- •8.Have normal cardiac function without treatment.
- •9.Have adequate organ function as indicated by the following laboratory values, obtained within 7 days prior to registration:
- •Inclusion Laboratory Values:
- •Parameter Required Value
- •Serum creatinine<2 × ULN for age
- •Serum bilirubin=1.5 × ULN
- •AST and ALT=10 × ULN
- •ULN = Institutional Upper Limit of Normal.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following criteria will be excluded from study admission:
- •1.Received previous treatment with clofarabine.
- •2.Patients with isolated extramedullary disease.
- •3.Have received prior bone marrow or peripheral blood stem cell transplant within the last 6 months.
- •4.Have received prior bone marrow or peripheral blood stem cell transplant more than 6 months ago, but now has compromised organ function.
- •5.Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment. Patients who have had a recent (<30 days) history of fungal or bacterial infection or who are receiving therapeutic doses of antibiotics or anti fungals.
- •6.Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.
- •7.Have psychiatric disorders that would interfere with consent, study participation, or follow-up.
- •8.Have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrolment. Treatment may start earlier, following consultation with the Medical Monitor, if there is evidence of disease relapse or progression prior to that time. Patients who have received growth factor, cytokine support, leukapheresis, or cranial irradiation will be allowed, but must discontinue treatment 24 hours prior to beginning treatment with clofarabine.
- •9.Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •10.Have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.
- •11.Have CNS disease.
研究者
相似试验
进行中（未招募）
不适用
A Phase II, Open-Label Study of Clofarabine in Paediatric Patients with Refractory / Relapsed Acute Lymphoblastic Leukaemiarefractory or relapsed Acute Lymphoblastic Leukemia (ALL)MedDRA version: 6.1Level: PTClassification code 10000846EUCTR2004-001853-27-ITBIOENVISIO
进行中（未招募）
不适用
A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute LeukemiasMedDRA version: 18.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864Acute Lymphoblastic LeukemiaEUCTR2015-001174-18-Outside-EU/EEAGenzyme Corporation15
进行中（未招募）
1 期
A study with a combination of two anticancer drugs as a salvage therapy for patients, affected by acute leukaemia aiming at lymphocites, adult not respondent to previous therapies or with a relapsing leukaemia.Acute Lymphoblastic Leukemia (ALL)MedDRA version: 14.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-019742-12-ITG.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
进行中（未招募）
1 期
A Randomized Phase II Study of Clofarabine / Intermediate-Dose Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC) as Consolidation in Younger Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML). - CLARAMedDRA version: 9.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaAcute Myeloid LeukemiaEUCTR2008-000668-18-FRHospices Civils de Lyon
进行中（未招募）
不适用
An open label phase II trial of Clofarabine and Temsirolimus in olderpatients with relapsed or refractory Acute Myeloid Leukemia (AML) - GIMEMA Protocol AML1107MedDRA version: 9.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaRelapsed or refractory Acute Myeloid Leukemia (AML)EUCTR2007-005374-31-ITG.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO