EUCTR2008-000668-18-FR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). - CLARA
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.Age 18 years or more and less than 60 years.
- •A morphologically proven diagnosis of AML according to the WHO classification, cytogenetically (standard karyotype, FISH-MLL) and molecularly (FLT3, CEBPA, NMP1) defined.
- •3.ECOG performance status 0 to 2.
- •4.Serum creatinine ? 2N; AST and ALT ? 2.5N; total bilirubin ? 2N (unless related to the underlying disease).
- •5.Cardiac function determined by radionucleide or echography within normal limits.
- •6.Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior the beginning treatment on this trial.
- •7.Must be able and willing to give written informed consent.
- •8.The subject must be covered by a social security system.
- •At randomization:
- •Patients with either in first CR/CRp after the first induction course or in first CR/CRp after salvage therapy.
- •ECOG performance status 0 to 2.
- •Serum creatinine ? 2N; AST and ALT ? 2.5N; total bilirubin ? 2N.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with AML with favorable risk cytogenetics: M3-AML; CBF-AML including t(8:21), inv(16), or t(16;16) AML.
- •2.Ph-positive AML.
- •3.AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months
- •4.Prior treatment with chemotherapy or radiotherapy for another tumor.
- •5.Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
- •6.Performance Status Score ECOG > 2.
- •7.Compromised organ function judged to be lifethreatening by the Investigator.
- •8.Positive serology for HIV, HBV and HBC (except post vaccination)
- •9.Uncontrolled active infection of any kind or bleeding. Patients with infections who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
- •10.Other active malignancy.
- •11. Patents concurrently receiving any other standard or investigational treatment for their leukemia, with the exception of hydroxyurea.
- •At randomization:
- •Absence of CR or CRp after induction chemotherapy or induction plus salvage chemotherapy.
- •Patients belonging to the intermediate 1 risk group (CEBPA+ or NPM1+ without Flt3-ITD) in CR/CRp after the first induction course.These patients will go out of the study and receive consolidation cycles based on HD-AraC.
- •Performance Status Score ECOG > 2.
- •Known central nervous system involvement with AML.
- •Uncontrolled active infection of any kind or bleeding.
- •Compromized organ function judged to be lifethreatening by the Investigator.
- •Patients scheduled and waiting for allogeneic stem cell transplantation (see Appendix 4). The idea is that no randomized patient should receive allogeneic stem cell transplantation after randomization.
研究者
相似试验
进行中（未招募）
不适用
A Phase I/II Multicenter Study of IV Clofarabine In Patients with High-Risk Myelodysplastic Syndrome who have failed Therapy with Azacitidine: the NIDEVOL study - GFM-clo-08In Patients with High-Risk Myelodysplastic Syndrome who have failed Therapy with AzacitidineMedDRA version: 9.1Level: LLTClassification code 10028533Term: Myelodysplastic syndromeEUCTR2009-013404-32-FRGroupe Francophone des Myélodysplasies (GFM)
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）
不适用
A Phase I/II study of clofarabine in combination with cytarabine and liposomal daunorubicin in children with relapsed/refractory pediatric AML - CLARA-DNXEUCTR2009-009457-13-ATErasmus MC28
进行中（未招募）
1 期
This study aims to investigate the safety and efficacy of clofarabine, given in combination with cytarabine and liposomal daunorubicin, in the treatment of children with relapsed/refractory acute myeloid leukemia (AML)EUCTR2009-009457-13-DEErasmus MC34
进行中（未招募）
不适用
This study aims to investigate the safety and efficacy of clofarabine, given in combination with cytarabine and liposomal daunorubicin, in the treatment of children with relapsed/refractory acute myeloid leukemia (AML)Relapsed/refractory acute myeloid leukemiaMedDRA version: 14.0Level: LLTClassification code 10066638Term: Acute myeloid leukemia progressionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-009457-13-NLErasmus MC28