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Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)

10 Years
19 Years
Not Enrolling

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Trial Information

Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)


- To compare the pharmacokinetics of prednisone/prednisolone, vincristine, and
daunorubicin hydrochloride among obese, middle-weight, and underweight children aged 10
to less than 20 years of age undergoing induction therapy for high-risk acute
lymphoblastic leukemia.

- To examine the relationship between the above parameters and response status as defined
by early response and induction failure.

OUTLINE: This is a multicenter study. Patients are stratified according to body mass index
(BMI) (≥ 95^th percentile [obese] vs 10^th to 95^th percentile [normal or at risk for
overweight] vs ≤ 10^th percentile [underweight]).

Patients receive anticancer therapy as prescribed by their treating clinicians. Patients
receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive
daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.

Blood samples are obtained on either day 1 or day 8** of induction therapy for
pharmacokinetic analysis of prednisone, daunorubicin hydrochloride, and vincristine activity

Blood samples are analyzed via high-performance liquid chromatography (HPLC),
ultrafiltration, a Nessler reaction, ELISA, and liquid chromatography using reverse-phase
chromatography, fluorescent detection, and solid-phase extraction.

Demographic information, including ethnicity, is also collected. Weight and height is
recorded at diagnosis and on the day pharmacokinetic assessment of vincristine, prednisone,
and daunorubicin hydrochloride begins.

NOTE: **Patients who are being sampled on day 8 of induction therapy and who have received
intravenous corticosteroid therapy in the first week of induction must have received at
least six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone
dose on day 8.

Inclusion Criteria


- Newly diagnosed acute lymphoblastic leukemia

- Must be assigned to receive prednisone/prednisolone, vincristine, and daunorubicin
during induction treatment in the doses and schedule as per the current COG AALL0232

- Prior registration onto a COG protocol is not required

- Must meet 1 of the following criteria:

- Obese (defined as a body mass index [BMI] ≥ 95^th percentile)

- Normal weight or at risk for overweight (defined as BMI between 10^th and 95^th

- Underweight (defined as ≤ 10^th percentile)


- Able to take either prednisone or prednisolone by mouth on day 1 or 8 of induction

- Not pregnant

- Negative pregnancy test

- AST/ALT < 5 times upper limit of normal (ULN)

- Total bilirubin (conjugated + unconjugated) < 1.5 mg/dL

- Creatinine ≤ 1.5 times ULN

- No known malabsorption syndrome


- See Disease Characteristics

- At least 2 weeks since prior and no concurrent medications or food known or with the
potential to alter the pharmacokinetics of the drugs under study including any of the

- Grapefruit, tangelos, or the juice of these fruits

- Hypericum perforatum (St. John's wort)

- Anticonvulsants

- Carbamazepine

- Oxcarbazepine

- Phenytoin

- Phenobarbital

- Primidone

- Azole antifungal agents including:

- Ketoconazole

- Fluconazole

- Itraconazole

- Voriconazole

- Macrolide antibiotics

- Erythromycin

- Clarithromycin

- Isoniazid

- Rifampin

- Verapamil

- Diltiazem

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Pharmacokinetic parameters of prednisone/prednisolone

Outcome Description:

Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.

Outcome Time Frame:

Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours

Safety Issue:


Principal Investigator

Lillian Sung, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children


United States: Federal Government

Study ID:




Start Date:

June 2008

Completion Date:

August 2009

Related Keywords:

  • Leukemia
  • childhood acute lymphoblastic leukemia in remission
  • untreated childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



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