IDEAL2 Intervention for B-cell Acute Lymphoblastic Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
B-cell Acute Lymphoblastic Leukemia+1 MoreIDEAL2 Intervention - Behavioral
Eligibility
10 - 25
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for 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.

Eligible Conditions
  • B-cell Acute Lymphoblastic Leukemia
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Prior to day 5 until end of induction (~day 35 from start of chemotherapy)

Day 35
Change in fat mass
EOI MRD positivity >= 0.01%
Proportion of patients with >=75% adherence to diet intervention
Proportion of patients with >=75% adherence to exercise intervention

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Control - Standard of Care
1 of 2
IDEAL2 intervention
1 of 2

Active Control

Experimental Treatment

240 Total Participants · 2 Treatment Groups

Primary Treatment: IDEAL2 Intervention · No Placebo Group · Phase 2

IDEAL2 intervention
Behavioral
Experimental Group · 1 Intervention: IDEAL2 Intervention · Intervention Types: Behavioral
Control - Standard of CareNoIntervention Group · 1 Intervention: Control - Standard of Care · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: prior to day 5 until end of induction (~day 35 from start of chemotherapy)

Who is running the clinical trial?

Etan OrgelLead Sponsor
Therapeutic Advances in Childhood Leukemia ConsortiumOTHER
19 Previous Clinical Trials
397 Total Patients Enrolled

Eligibility Criteria

Age 10 - 25 · All Participants · 8 Total Inclusion Criteria

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You are a female of childbearing potential.