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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00900445




Registration number
NCT00900445
Ethics application status
Date submitted
9/05/2009
Date registered
12/05/2009
Date last updated
7/08/2018

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
NCI-2011-02151
Secondary ID [2] 0 0
ACCL0631
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia 0 0
Untreated Childhood Acute Lymphoblastic 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
Other interventions - Pharmacological Study
Treatment: Drugs - Prednisolone
Treatment: Drugs - Prednisone
Treatment: Drugs - Vincristine Sulfate

Basic science (pharmacokinetics) - 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.


Treatment: Drugs: Daunorubicin Hydrochloride
Given IV

Other interventions: Pharmacological Study
Correlative studies

Treatment: Drugs: Prednisolone
Given orally

Treatment: Drugs: Prednisone
Given orally

Treatment: Drugs: Vincristine Sulfate
Given IV
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
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 daunorubicin hydrochloride
Timepoint [2] 0 0
Pre-dose, 0.5, 0.75, 1, 2, 4, 8, 12, 24 to 36 hours, and 48 to 72 hours
Primary outcome [3] 0 0
Pharmacokinetic parameters of vincristine sulfate
Timepoint [3] 0 0
Pre-dose, 0.5, 1, 2, 4, 8, 24 to 36 hours, and 48 to 72 hours
Secondary outcome [1] 0 0
RER and SER status
Timepoint [1] 0 0
Up to 1.5 years

Eligibility
Key inclusion criteria
- Patients must be newly diagnosed with acute lymphoblastic leukemia and the intended
induction treatment must contain prednisone/prednisolone, vincristine and daunorubicin
in the doses and schedule as per the current COG AALL0232 protocol; prior registration
onto a COG protocol is not required

- Patients must be able to take either prednisone/prednisolone reliably by mouth on day
1 or 8 of induction (depending on sampling schedule chosen); patients who are being
sampled on Induction day 8 and who have received intravenous corticosteroid therapy in
the first week of induction must have received a minimum of six oral
prednisone/prednisolone doses prior to the morning prednisone/prednisolone dose on
induction day 8
Minimum age
10 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Serum transaminase concentrations >= 5 X ULN for age

- Total serum bilirubin (conjugated + unconjugated) >= 1.5 mg/dl (>= 26 micromol/L)

- Serum creatinine > 1.5 X ULN for age

- With the exception of prednisone/prednisolone, receipt of medications or food known or
with the potential to alter the pharmacokinetics of the drugs under study within 14
days of diagnosis and throughout the period of pharmacokinetic sampling; such agents
include but are not limited to: grapefruit, tangelos or the juice of these fruits; St.
Johns wort; anticonvulsants: carbamazepine, oxcarbazepine, phenytoin, phenobarbital,
primidone; azole antifungal agents: ketoconazole, fluconazole, itraconazole,
voriconazole; macrolide antibiotics: erythromycin, clarithromycin; isoniazid;
rifampin; verapamil; and diltiazem

- Presence of known malabsorption syndrome

- Females with known pregnancy (pregnancy test must be negative to be eligible)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania

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
This clinical trial is studying body mass index in younger patients receiving
prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute
lymphoblastic leukemia. 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00900445
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Ian Pollack
Address 0 0
Children's Oncology Group
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/ct2/show/NCT00900445