Omacetaxine for Consolidation and Maintenance in Patients Age ≥ 55 With AML in First Remission: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Assessment of Disease Status
研究概览
简要总结
The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first complete remission following induction with cytarabine and an anthracycline, and also to assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and older with acute AML in first complete remission following 3 consolidation courses with omacetaxine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria.
- •Age ≥ 55 years.
- •Patient eligible for standard induction chemotherapy based on Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function at the discretion of the treating physician.
- •Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible.
- •Provide signed written informed consent.
- •Be able to comply with study procedures and follow-up examinations.
- •Be non-fertile or agree to use birth control during the study through the end of last treatment visit.
- •Adequate renal and hepatic function at the time of second registration:
- •Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); and
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and
- •Serum creatinine ≤ 1.2 x ULN.
- •ECOG performance ≤ 2 at the time of second registration.
- •Patients with a history of carcinoma in remission, on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are included in the study.
排除标准
- •Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t (15;17)(q22;q12), (PML/retinoic acid receptor alpha [RARa] and variants).
- •Prior treatment with omacetaxine.
- •Relapsed or refractory AML.
- •Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug.
- •Psychiatric disorders that would interfere with consent, study participation, or follow-up.
- •Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy. This includes uncontrolled hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia have been reported (using continuous infusion at higher doses of omacetaxine).
- •Active carcinoma requiring systemic chemotherapy or radiation therapy.
研究组 & 干预措施
Omacetaxine: Consolidation/Maintenance
干预措施: Omacetaxine (Drug)
结局指标
主要结局
Assessment of Disease Status
时间窗: 1 month
Bone marrow biopsy and aspirate will be obtained.
Disease Status Assessment Prior to Each Consolidation Cycle
时间窗: 14 days
Disease status will be assessed by a bone marrow aspirate and biopsy prior to each of 3 consolidation cycles (to ensure that patients are still in remission).
Bone Marrow Aspirate to Confirm Continuous Remission
时间窗: 3 months
Bone marrow aspirate to confirm continuous remission will be obtained before starting maintenance and at 3 and 6 months from the start of maintenance.
Maintenance Toxicities
时间窗: 24 weeks
Toxicities will be monitored by history, physical examination, and laboratory monitoring during maintenance.
次要结局
- Consolidation Toxicities(12 weeks)