A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 36
- 主要终点
- EOI MRD positivity >= 0.01%
研究概览
简要总结
This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight.
This study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month.
详细描述
GOALS AND OBJECTIVES
Hypothesis: Caloric restriction with increased physical activity integrated into induction chemotherapy will decrease chemoresistance and reduce minimal residual disease (MRD). In children receiving induction therapy for NCI/Rome high-risk B-cell acute lymphoblastic leukemia (HR B-ALL),
1.1 Primary Objectives
- To examine efficacy of the IDEAL2 (Improving Diet and Exercise in ALL) caloric restriction and activity intervention integrated into HR B-ALL induction to reduce incidence of end of induction (EOI) MRD ≥0.01%.
- To examine the efficacy of the IDEAL2 intervention to reduce gain in fat mass during induction
1.2 Secondary Objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 7.0 and <26.0 years of age.
- •Patients must have a diagnosis of de novo B-ALL
- •Patients must have a M3 marrow (>25% blasts by morphology) or at least 1,000/µL circulating leukemia cells in PB confirmed by Flow Cytometry (or other convincing evidence of a B-ALL diagnosis not meeting above criteria following central review by the Study Hematopathologist and Study Chair or Vice-Chair).
- •The treatment regimen must be the first treatment attempt for B-ALL-
- •Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase/calaspargase, and daunorubicin or doxorubicin and with a planned duration <35 days.
- •Organ function must meet that required for initiation of chemotherapy
- •Patients at diagnosis must meet Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for patients ≤ 16 years of age (or be expected to recover prior to Day 8) .
- •If the patient is a female of childbearing potential, a negative urine or serum pregnancy test is required within two weeks prior to enrollment.
排除标准
- •Patient will be excluded if they are underweight at time of enrollment (BMI% <5th percentile for age for patients age 10-19 years, BMI <18.5 in patients 20-29 years).
- •Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded.
- •Patient receiving a SJCRH-style "Total Therapy" regimen will be excluded.
- •Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy.
- •Patients will be excluded if they received treatment for a previous malignancy.
- •Patient will be excluded if they are pregnant.
- •Patient will be excluded if they have a pre-diagnosis requirement for enteral or parenteral supplementation .
- •Patient will be excluded due to inability to perform the intervention (e.g., specific nutritional needs, severe developmental delay, paraplegia)
- •Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results
研究组 & 干预措施
IDEAL2 intervention
Focused and short-term intervention of diet and exercise during induction. Calorie goal is >=15% daily deficit as determined by each subject's estimated energy requirement. Fat intake will make up <25% of daily calories. Carbohydrate will make up <55% of daily calories consisting of "low" glycemic load foods (<100/2,000 kcal adjusted for daily calories). Protein will make up >=20% of daily calories. Subjects will also perform moderate exercise 5 days per week for 30 minutes/session (total = 150 minutes per week). Subjects will have a step goal to decrease sedentary behavior, with a starting goal of >=1000 steps/day and increasing by at least 1000 steps/day each week.
干预措施: IDEAL2 Intervention (Behavioral)
Control - Standard of Care
One-time education of diet and exercise, which is the standard of care for ALL patients during induction.
结局指标
主要结局
EOI MRD positivity >= 0.01%
时间窗: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)
To compare the rate of MRD \>=0.01% at end of induction between experimental arm and control arm
Change in fat mass
时间窗: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)
To compare the % change in fat mass from baseline to end of induction between the experimental arm and control arm
次要结局
- Proportion of patients with >=75% adherence to diet intervention(Prior to day 5 until end of induction (~day 35 from start of chemotherapy))
- Proportion of patients with >=75% adherence to exercise intervention(Prior to day 5 until end of induction (~day 35 from start of chemotherapy))
研究者
Etan Orgel
Principal Investigator
Therapeutic Advances in Childhood Leukemia Consortium