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2010年9月28日
适应症Patients with AML >40 years of age with untreated relapse or refractory disease after a minimum of one standardinduction therapy.MedDRA version: 14.1Level: LLTClassification code 10060557Term: Acute myelocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
相关药物Evoltra
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Patients with AML >40 years of age with untreated relapse or refractory disease after a minimum of one standardinduction therapy.
- 发起方
- Dresden Universtity of Technology
- 状态
- 进行中（未招募）
- 最后更新
- 12年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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.
结局指标
主要结局
未指定
相似试验
进行中（未招募）
不适用
Clofarabine based remission induction followed by haploidentical stem celltransplantation in children with refractory hematological malignanciesEUCTR2009-012437-30-SESkånes University Hospital
招募中
1/2 期
Clofarabine Therapy in Patients with Locally Advanced or Metastatic
Urothelial Carcinoma: a Phase 1/2 Dose-Escalation Study2024-516586-37-00Medical University Of Vienna50
进行中（未招募）
1 期
Clofarabine in combination with a standard remission induction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial). - AML-14APreviously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS)MedDRA version: 14.1Level: LLTClassification code 10028532Term: MyelodysplasiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2006-004912-28-BEEuropean Organisation for Research and Treatment on Cancer60
已完成
2 期
Clofarabine in combination with a standard remission induction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasie (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial)acute myeloid leukemia10024324NL-OMON38148European Organisation for Research in Treatment of Cancer (EORTC)40
进行中（未招募）
不适用
CLOFARABINE/ARA-C TREATMENT COMBINED WITH REDUCED-INTENSITY CONDITIONING ALLOGENEIC STEM CELL TRANSPLANTATION FOR ACUTEMYELOID LEUKEMIA IN PRIMARY TREATMENT FAILURE - SET-RICTo improve the 2 year overall survival in patients with acute myeloid leukaemia (AML) in primary treatment failureEUCTR2009-015176-10-FRCHU de Nantes