Log in

T2020-003

TACL T2020-003 IDEAL 2

 

Protocol Title:

A PHASE 2 RANDOMIZED TRIAL OF CALORIC RESTRICTION AND ACTIVITY TO REDUCE CHEMORESISTANCE IN B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (IDEAL2)

 

Study Chair:           

Dr. Etan Orgel, MD – Children’s Hospital of Los Angeles

 

Study Vice Chair:   

Dr. Sarah Tasian, MD – Children’s Hospital of Philadelphia

 

What is this study about:

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 a personalized nutritional menu and exercise plan during your routine chemotherapy can make your ALL more sensitive to chemotherapy and reduce the amount of body fat gained during treatment. 

 

Why is this study being done:

 

The goals of this study are to help make your chemotherapy more effective in treating your leukemia while also trying to reduce the amount of body fat that chemotherapy causes you to gain in the first month.

 

Criteria that need to be met to participate in this study: (Abbreviated List)

 

  • Patients must be greater than or equal to 10 years of age and less than 26 years of age to be participate in this study.

  • Patients must have a new diagnosis of B-ALL.

  • Patient must be on their first treatment attempt of B-ALL 

 

Patients cannot participate in the study if: (Abbreviated List)

 

  • They are underweight at the time of enrollment (BMI% <5th percentile for age for patients age 10-19 years, BMI <18.5 in patients 20-26 years).

  • They have Down Syndrome or a DNA fragility syndrome

  • They have received treatment for a previous cancer

  • They are pregnant.

  • They have a pre-diagnosis requirement for nutritional support (such as formula feeds through a tube or nutrition through an IV).

  • They cannot perform the intervention

 

Treatment

At the beginning of your chemotherapy, if you participate in the study, you will receive an education session regarding diet and exercise during cancer therapy.  For half of those who participate, this education session will then be followed by an intensive program designed to help you reduce the amount of calories you eat day to day, help you exercise, and increase your overall level of activity. A dietitian and physical therapist will guide you through the program for the entire first month of your therapy.  The name of this program (or intervention) is “Improving Diet and Exercise in ALL”, or IDEAL. 

 

By agreeing to participate, you are agreeing to be randomized between the education session alone and the more intensive program with the dietitian and physical therapist.  Being randomized means that half the people will receive one and half of people will receive the other. This is not decided by you or your doctors, but is based on chance, like the flip of a coin. You will have an equal chance of being in either group, and you will know what treatment you are getting.

 

Treatment will last 1 month. At the end of the month, you will have a routine evaluation by your treatment team to see how your leukemia is responding to therapy.  Following this evaluation, all patients will continue for another 60 days to see how long benefit to you from the education or IDEAL program lasts following the first month of therapy.