NCT00670150撤回2 期
Phase II Study of NRX 195183 Induction and NRX 195183 Combined With Arsenic Trioxide (As2o3) as Initial Consolidation Therapy Followed by Continuous NRX 195183 Maintenance Therapy for Patients With Untreated Acute Promyelocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The primary endpoint is achieving a partial or complete response
研究概览
简要总结
The safety and efficacy of combining NRX 195183 with arsenic trioxide in treating untreated APL will be assessed.
详细描述
The primary objectives of this study are in newly diagnosed APL patients:
- To evaluate the efficacy (complete and molecular response rates) and toxicity of NRX 195183 in induction therapy
- To evaluate the efficacy (molecular response rates) and toxicity of NRX 195183 in combination with arsenic trioxide (As2O3) in consolidation therapy.
- To evaluate the efficacy (event free-survival, disease-free survival) and toxicity of NRX 195183 as maintenance therapy for patients with APL who achieve a molecular complete response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis Patients must have a clinical diagnosis of acute promyelocytic leukemia (APL) morphology or FAB M3 variant confirmed by RT-PCR assay for PML-RARα or chromosome analysis/FISH showing t(15:17) translocation. A patient may be entered prior to confirmatory studies, but a patient who is subsequently found to be PML-RARα negative will be removed from protocol treatment.
- •Prior Treatment The patient must not have received any systemic definitive treatment for APL, including cytotoxic chemotherapy, retinoids or arsenic trioxide. Prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient.
- •Age: Patients must be of age eighteen (18) or above.
- •Other Criteria
- •Patients must have the following laboratory values:
- •Bilirubin equal or less than 1.5 times the upper limit of normal.
- •Creatinine equal or less than 1.5 times the upper limit of normal
- •Pregnancy / Nursing Status
- •Patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. Treatment under this protocol would expose an unborn child to significant risks. treatment. Women and men of reproductive potential should agree to use an effective means of birth control. There is an extremely high risk of fetal malformation if pregnancy occurs while on treatment in any amount with retinoid drugs even for short periods.
排除标准
- •Non-APL, AML patients should be excluded from the study.
- •Other serious illnesses which would limit survival to 1 year.
- •Psychiatric conditions which would prevent compliance with treatment or informed consent.
- •Uncontrolled or severe cardiovascular disease. This would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
- •AIDS or HIV positive patients, although HIV test is not required for accrual.
结局指标
主要结局
The primary endpoint is achieving a partial or complete response
时间窗: Bone marrow biopsies will be done monthly during induction
次要结局
- Safety and feasibility(Twice weekly during induction and then weekly during consolidation)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AMLMyelodysplastic SyndromeNCT00195104Weill Medical College of Cornell University87
已完成
2 期
Phase 2 study of ATRA and arsenic trioxide for acute promyelocytic leukemiaacute promyelocytic leukemiaJPRN-UMIN000012004Department of Hematology, Hiroshima University Hospital45
已完成
2 期
Arsenic Trioxide in Treating Patients With Urothelial CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerTransitional Cell Carcinoma of the BladderUreter CancerNCT00009867National Cancer Institute (NCI)35
已完成
2 期
All-trans Retinoic Acid, and Arsenic +/- IdarubicinAcute Promyelocytic LeukemiaNCT00413166M.D. Anderson Cancer Center78
撤回
2 期
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaAdult Acute Megakaryoblastic Leukemia (M7)Adult Acute Minimally Differentiated Myeloid Leukemia (M0)Adult Acute Monoblastic Leukemia (M5a)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Acute Myelomonocytic Leukemia (M4)Adult Erythroleukemia (M6a)Adult Pure Erythroid Leukemia (M6b)Recurrent Adult Acute Myeloid LeukemiaNCT01835288Stanford University