A Pilot Study of Physical Conditioning and Decitabine for Newly Diagnosed AML Patients Age ≥ 60 Who Are Not Candidates for Standard Induction Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Activity
研究概览
简要总结
STUDY BACKGROUND AND PURPOSE:
Acute myelogenous leukemia (AML) is a common type of blood cancer in adults, and is more common with increasing age. AML is harder to treat in older patients, with typically poor responses to standard chemotherapy.
Patients with AML are typically given intensive induction chemotherapy, but many older patients cannot tolerate the side effects of this therapy. Decitabine has been shown to be active and better tolerated in frail patients with AML; however, most patients still relapse.
Recent studies suggest that improving the performance status and fitness of older AML patients prior to induction chemotherapy may help to lessen side effects.
This study will test the combination of decitabine treatment with physical exercise in elderly patients with AML who are not candidates for standard induction chemotherapy.
STUDY DESCRIPTION:
This is a pilot study to test the combination of decitabine treatment with an 8-week physical exercise program in AML patients ≥ 60 years of age who are not candidates for standard induction chemotherapy. Patients who are eligible to take part must give their written agreement before they can be enrolled.
This study will enroll 20 patients who are not candidates for standard induction chemotherapy. Patients will begin an 8-week program of physical exercise, including 2-3 sessions per week supervised by a physical therapist. During this 8-week period, patients will be given 2 cycles of decitabine therapy (daily infusion for 5 consecutive days of a 28-day cycle).
Patients will be followed to assess the safety and tolerability of the program. Patients will also give blood samples that will be used to assess their response to treatment. Patients will be evaluated for their physical fitness before and after the 8-week exercise program and will complete questionnaires to assess their quality of life before and after the program.
详细描述
Primary Objectives:
• Number of patients age 60 and older with newly diagnosed AML and who are not candidates for standard induction chemotherapy who complete an 8-week program of physical conditioning and decitabine treatment. The goal is set at 30% of 20 enrolled patients completing the 8 weeks of decitabine and physical conditioning program.
Secondary Objectives:
- Number of patients with adverse events as a measure of safety and tolerability of the physical conditioning program during decitabine therapy.
- Number of patients with overall response (complete response, disease-free survival [DFS], and overall survival [OS]) of the rehabilitated patients after conclusion of the 8-week program.
- Changes in quality of life among study subjects before and after the 8-week exercise program.
- Changes in cytokine profiles drawn at baseline, 4 weeks and 8 weeks.
Treatment Plan:
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
- 60 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 ≥ 60 years
- •Patient not eligible for (immediate) standard induction chemotherapy based on the opinion of the treating physician and the frailty score
- •Provide signed written informed consent
- •Be able to comply with study procedures and follow-up examinations
- •Adequate heart function with echocardiogram demonstrating ejection fraction ≥ 45% with no evidence of systolic dysfunction
- •Adequate renal and hepatic function:
- •Total bilirubin ≤ 2x institutional Upper Limit of Normal (ULN); and
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN; and
- •Serum creatinine ≤ 2 times the upper limit of normal
- •ECOG performance < 4
- •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 decitabine for myelodysplastic syndrome (MDS) or AML
- •Relapsed or refractory AML
- •Rapidly doubling white cell count uncontrolled with hydroxyurea
- •Coronary artery disease with angina limiting exercise capability
- •Joint disease limiting exercise capability
- •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 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
- •No social support or inability to attend study-related visits
- •Carcinoma requiring systemic chemotherapy or radiation therapy
研究组 & 干预措施
Decitabine and Exercise
8-week program of physical conditioning and decitabine treatment in newly diagnosed AML patients ≥ 60 years of age who are not candidates for standard induction chemotherapy.
干预措施: Decitabine (Drug)
Decitabine and Exercise
8-week program of physical conditioning and decitabine treatment in newly diagnosed AML patients ≥ 60 years of age who are not candidates for standard induction chemotherapy.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Activity
时间窗: 8 weeks
Activity will be based on daily stepping activity (measured using step activity monitors), endurance (distance ambulated in 3-minutes), and duration of aerobic exercise (treadmill walking or cycling) at 50% heart rate and/or Borg score \> 5.
Performance status
时间窗: Up to 8 weeks
ECOG performance status is assessed before, at 4 weeks and 8 weeks from start of the intervention.
Function
时间窗: 8 weeks
Function will be measured using the 6-meter walk test, timed Up and Go test, grip strength and lower limb strength.
Proportion of patients with 25% improvement in fitness scores
时间窗: Up to 8 weeks
Patients will be asked to answer questions on the 36-item (SF-36) fitness scoring system and the FACIT-Leu fatigue scale at baseline, 4 weeks and 8 weeks of the study.
次要结局
- Response to treatment(18 months)
- Quality of life and depression scores among study subjects before and after the 8-week exercise program(8 weeks)
- Number of patients with adverse events related to the intervention.(8 weeks)
研究者
Martha Arellano
Principal Investigator
Emory University