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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00900445




Registration number
NCT00900445
Ethics application status
Date submitted
9/05/2009
Date registered
9/05/2009
Date last updated
30/05/2013

Titles & IDs
Public title
Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia
Scientific title
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)
Secondary ID [1] 0 0
COG-ACCL0631
Secondary ID [2] 0 0
ACCL0631
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - daunorubicin hydrochloride
Treatment: Drugs - prednisolone
Treatment: Drugs - prednisone
Treatment: Drugs - vincristine sulfate
Other interventions - pharmacological study

Obese - Pts are stratified according to body mass index (BMI) (= 95th percentile [obese]. Pts receive anticancer therapy and prednisone/prednisolone orally 2x on either day 1 or day 8. Pts receive daunorubicin hydrochloride IV over 30 minutes and vincristine sulfate 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 levels.
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 the pharmacological study of vincristine sulfate, prednisone, and daunorubicin hydrochloride begins.

Normal - Pts are stratified according to body mass index (BMI) 10th to 95th percentile [normal or at risk for overweight].
Blood samples are obtained on either day 1 or day 8 of induction therapy for pharmacokinetic analysis of prednisone, daunorubicin hydrochloride, and vincristine sulfate activity levels.
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 the pharmacological study of vincristine sulfate, prednisone, and daunorubicin hydrochloride begins

Underweight - Patients are stratified according to body mass index (BMI) = 10th percentile [underweight]).
Blood samples are obtained on either day 1 or day 8 of induction therapy for pharmacokinetic analysis of prednisone, daunorubicin hydrochloride, and vincristine sulfate activity levels.
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 the pharmacological study of vincristine sulfate, prednisone, and daunorubicin hydrochloride begins


Treatment: Drugs: daunorubicin hydrochloride
Given IV

Treatment: Drugs: prednisolone
Given orally

Treatment: Drugs: prednisone
Given orally

Treatment: Drugs: vincristine sulfate
Given IV

Other interventions: pharmacological study
Correlative studies

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic parameters of prednisone/prednisolone - 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.
Timepoint [1] 0 0
Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours
Primary outcome [2] 0 0
Pharmacokinetic parameters of vincristine sulfate - 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.
Timepoint [2] 0 0
Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours
Primary outcome [3] 0 0
Pharmacokinetic parameters of daunorubicin hydrochloride - 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.
Timepoint [3] 0 0
Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours
Secondary outcome [1] 0 0
RER and SER status - To examine the relationship between pharmacokinetic parameters and RER versus SER status, univariate and multiple logistic regressions will be performed.
Timepoint [1] 0 0
Up to 1.5 years

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- 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
protocol

- 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
percentile)

- Underweight (defined as = 10^th percentile)

PATIENT CHARACTERISTICS:

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

- 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

PRIOR CONCURRENT THERAPY:

- 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
following

- 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
Minimum age
10 Years
Maximum age
19 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help
doctors learn more about the affect of body mass index on the way anticancer drugs work in
the body. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying body mass index in younger patients receiving
prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute
lymphoblastic leukemia.
Trial website
https://clinicaltrials.gov/show/NCT00900445
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lillian Sung, MD, PhD
Address 0 0
The Hospital for Sick Children
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00900445