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Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)


Phase 2
10 Years
29 Years
Open (Enrolling)
Both
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Vitamin D Deficiency

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Trial Information

Nutrition and Body Composition in Acute Lymphoblastic Leukemia (Environment and Microenvironment in ALL #2)


Inclusion Criteria:



GROUP A: PATIENTS WITH NEWLY DIAGNOSED ALL:

- Are greater than or equal to 10 years of age and less than or equal to 21 years of
age at diagnosis of ALL

- Have a new diagnosis of untreated ALL classified as "high risk" per NCI criteria (due
to being greater than 10 years of age)

- Are beginning treatment with a Children's Cancer Group/Children's Oncology Group
"high risk" protocol with a 4-drug induction including steroids

- Are not pregnant

GROUP B: EARLY SURVIVORS OF ALL

- Were treated for ALL and remain in first complete remission ("CR1")

- Were equal to or greater than 10 years of age and less than or equal to 21 years of
age at diagnosis of ALL

- Have completed treatment on or as per a Children's Cancer Group/Children's Oncology
Group "high risk" protocol between 12 and 48 months prior to enrollment in this study
(consisting of a plan for a 4-drug induction including steroids in Induction, Delayed
Intensification, and steroid pulses in Maintenance. Steroids are allowed to have
been discontinued due to toxicity).

- Are not pregnant

GROUP C: SIBLINGS OF GROUP A

- Are either a full-sibling or a half-sibling of a patient in Group A

- Are living at the same residence as the sibling/half-sibling from Group A

- Are greater than or equal to 10 years of age and less than or equal to 21 years of
age at the time of study entry, and within 3 years of the age diagnosis of ALL in the
sibling/half-sibling from Group A

- Are on the same Vitamin D supplementation regimen (if any) as the sibling from Group
A at the time of his or her diagnosis

Exclusion Criteria (ALL GROUPS):

- Have a diagnosis of Down syndrome (Trisomy 21) or any genetic disease associated with
abnormal bone development

- Are undergoing treatment with other medicines that affect bones including chronic use
of of steroids, bisphosphonate therapy, or Vitamin D at average dose greater than
400IU/day

- Have an underlying diseases altering body structure (i.e. missing a limb, severe
dysmorphism) or severely affecting mobility (i.e. total or hemiparesis)

- Have a history of chemotherapy or radiation for other cancers

- Cannot complete the radiology exams/radiology exams uninterpretable (i.e. people with
a hip replacement or prosthesis)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Repletion of serum Vitamin D Status

Outcome Description:

Repletion of serum Vitamin D levels (to greater than 30 ng/ml) will be measured at the end of Delayed Intensification #1 phase in the group of newly diagnosed patients and at the end of a 6 month period in the early survivor group.

Outcome Time Frame:

6 - 8 months

Safety Issue:

No

Principal Investigator

Etan Orgel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Los Angeles

Authority:

United States: Institutional Review Board

Study ID:

CCI-10-00273

NCT ID:

NCT01317940

Start Date:

March 2011

Completion Date:

March 2019

Related Keywords:

  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Vitamin D Deficiency
  • Leukemia
  • ALL
  • Vitamin D
  • Bone Density
  • Body Fat
  • Obesity
  • Adipose
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Vitamin D Deficiency

Name

Location

Children's Hospital Los AngelesLos Angeles, California  90027-0700