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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/NCT00268528
Registration number
NCT00268528
Ethics application status
Date submitted
20/12/2005
Date registered
22/12/2005
Date last updated
7/07/2020
Titles & IDs
Public title
Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission
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Scientific title
Understanding the Ethnic and Racial Differences in Survival in Children With Acute Lymphoblastic Leukemia
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Secondary ID [1]
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NCI-2009-00305
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Secondary ID [2]
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AALL03N1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Childhood Acute Lymphoblastic Leukemia in Remission
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Behaviour - Compliance Monitoring
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Other interventions - Questionnaire Administration
Other interventions - Study of Socioeconomic and Demographic Variables
Health service research (electronic pill monitoring system) - Patients receive an electronic pill monitoring system comprising an empty MEMS^? medication bottle with TrackCap? CR. The mercaptopurine prescription is filled using this system. Beginning on day 1 of the third or later course of maintenance therapy, patients take all doses of mercaptopurine from the MEMS^? medication bottle with TrackCap? CR for at least 169 days. The MEMS^? TrackCap? CR is mailed to the Coordinating Center at the end of study. Patients also receive methotrexate PO as indicated by their individual chemotherapy regimen.
Behaviour: Compliance Monitoring
Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Methotrexate
Given PO
Other interventions: Questionnaire Administration
Ancillary studies
Other interventions: Study of Socioeconomic and Demographic Variables
Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap
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Intervention code [1]
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Behaviour
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Intervention code [2]
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Other interventions
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Intervention code [3]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adherence to 6-MP as measured by 6TGN and MethylTIMP levels
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Assessment method [1]
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Will initially perform an exploratory data analysis on distributions across the four groups using side-by-side boxplots, histograms, and summary quantities (mean, median, quartiles, standard deviations, inter-quartile-range, etc.). If central values summarize across-group differences well, then mean and median of the distribution will be compared between 6 pairs of the four ethnic groups using the two-sample t-test and the Mann-Whitney U-test. Will perform these tests adjusting for 6 pairwise multiple comparisons among the four groups using the Bonferroni?s correction method.
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Timepoint [1]
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169 days
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Primary outcome [2]
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Adherence as measured by frequency of 6-MP dosing as a continuous variable using MEMS? defined as the number of days the MEMS? Cap openings are recorded, taken as a percentage of days doses were prescribed during the study period
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Assessment method [2]
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Will initially perform an exploratory data analysis on distributions across the four groups using side-by-side boxplots, histograms, and summary quantities (mean, median, quartiles, standard deviations, inter-quartile-range, etc.). If central values summarize across-group differences well, then mean and median of the distribution will be compared between 6 pairs of the four ethnic groups using the two-sample t-test and the Mann-Whitney U-test. Will perform these tests adjusting for 6 pairwise multiple comparisons among the four groups using the Bonferroni?s correction method.
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Timepoint [2]
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Up to 169 days
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Primary outcome [3]
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Self-report of adherence to 6-MP by questionnaire, defined as the number of days doses of 6-MP are reported to being taken, as a percentage of days doses were prescribed during the study period
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Assessment method [3]
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Will initially perform an exploratory data analysis on distributions across the four groups using side-by-side boxplots, histograms, and summary quantities (mean, median, quartiles, standard deviations, inter-quartile-range, etc.). If central values summarize across-group differences well, then mean and median of the distribution will be compared between 6 pairs of the four ethnic groups using the two-sample t-test and the Mann-Whitney U-test. Will perform these tests adjusting for 6 pairwise multiple comparisons among the four groups using the Bonferroni?s correction method.
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Timepoint [3]
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169 days
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Primary outcome [4]
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EFS
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Assessment method [4]
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For each of the three types of adherence measures, will fit independent Cox?s proportional-hazard models to assess the prognostic significance of the adherence measure on EFS, after adjusting for known predictors of disease outcome, including the National Cancer Institute risk group (based on the age at diagnosis and presenting white cell count) and chromosomal abnormalities.
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Timepoint [4]
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Up to 10 years
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Primary outcome [5]
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Critical level of adherence (measured independently by 6TGN/MethylTIMP, MEMS?, self-report) that has a significant impact on EFS
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Assessment method [5]
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Will fit a separate Cox regression model to each of the three adherence measures (i.e., 6TGN, MeTIMP, MEMS, and self-report). Using no more than several knots, the natural spline (a special type of cubic splines) fits a very wide range of smoothly changing adherence effects. The adherence effects on EFS will be visualized graphically. This will be the primary approach for defining the critical level of adherence. To confirm the spline analysis results, will categorize the continuous adherence measures into multiple levels and estimate the effect of each adherence level.
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Timepoint [5]
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Up to 10 years
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Primary outcome [6]
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Prevalence of adherence to 6-MP by ethnicity (measured independently by 6TGN/MethylTIMP, MEMS?, Self-report) that has a significant impact on EFS
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Assessment method [6]
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Will describe the prevalence of non-adherence by race/ethnicity and compare the prevalence by using two-tailed chi-squared test (with a Yates' correction).
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Timepoint [6]
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Up to 10 years
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Primary outcome [7]
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Behavioral, socio-demographic predictors of adherence using the questionnaire data
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Assessment method [7]
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The reasons for non-adherence will be assessed. The relationship between adherence to 6-MP as reported by the patients/parents and the independent behavioral variables knowledge of medications, understanding of treatment regimen, extent of treatment side effects, length of treatment, and beliefs about the efficacy of the regimen, beliefs and attitudes towards health and medical care will be evaluated descriptively first using standard parametric or non-parametric tests, and then analytically by logistic regression (dichotomous adherence) or linear regression (continuous adherence).
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Timepoint [7]
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Up to 10 years
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Primary outcome [8]
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Pill-taking practices using the MEMS? data
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Assessment method [8]
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Using the MEMS? output data, the adherence report will be analyzed for: i) longest and shortest interval between doses in hours; ii) percent prescribed doses taken, and iii) percent prescribed doses taken on schedule.
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Timepoint [8]
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Up to 169 days
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Primary outcome [9]
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Impact of adherence (measured independently by 6TGN/MethylTIMP, MEMS, self-report) on ethnic/racial differences in EFS
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Assessment method [9]
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Will fit independent Cox?s proportional-hazard models to assess the impact of adherence measure on EFS, after adjusting for known predictors of disease outcome, including the National Cancer Institute risk group (based on the age at diagnosis and presenting white cell count) and chromosomal abnormalities.
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Timepoint [9]
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Up to 10 years
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Secondary outcome [1]
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Concordance among red cell thiopurine metabolite levels, electronic pill monitoring, and self-reported adherence among the ethnic/racial groups
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Assessment method [1]
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Correlations between mean dosage- and TPMT-normalized serial red cell 6-MP metabolites and mean adherence by electronic pill monitoring system and self-report will be assessed for statistical significance by Spearman's rank correlation coefficient.
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Timepoint [1]
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Up to 168 days
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Eligibility
Key inclusion criteria
- Diagnosis of ALL in first remission, irrespective of risk stratification; enrollment
on a Children's Oncology Group (COG) therapeutic study for ALL is not required, but
the treatment plan must meet the criteria in this protocol
- Belongs to one of the four following ethnic/racial categories: African-American,
Asian, Caucasian, or Hispanic; below please find definitions for these categories
- African-American: includes patients who are African-American or of sub-Saharan
black African ancestry
- Asian: patients of Asian ancestry, including the following: Asian Indian
(subcontinent), Chinese, Japanese, Korean, Native Hawaiian, Guamanian or
Chamorro, Pacific Islander, Filipino, Vietnamese, Samoan, Hmong, Cambodian, Thai,
Laotian, or Other Asian races
- Caucasian: includes White or light-skinned patients of European, North African,
or Middle Eastern ancestry
- Hispanic: patients of Hispanic ethnicity, including the following: Mexican,
Mexican American, Chicano, Cuban, Puerto Rican, or Other Spanish/Hispanic/Latino
ethnicity
- Receiving self- or parent/caregiver-administered oral anti-metabolite chemotherapy
during the maintenance/continuation phase of therapy; patients are eligible if their
treatment plan calls for the following doses of 6-MP and methotrexate (MTX) during the
maintenance/continuation phase: 6-MP ? 75 mg/m^2/day orally; MTX 20 mg/m^2/week
orally;** (modification of 6-MP or MTX dosing based on laboratory or clinical
parameters is acceptable)
- For guidance regarding if and when a patient being treated on or according to a
specific COG (or legacy group) protocol is eligible, please refer to ?AALL03N1
Eligibility by Protocol Tool,? available in the study data forms packet on the
COG website
- Has completed at least 24 weeks of maintenance/continuation chemotherapy, and is
scheduled to receive at least 24 more weeks of maintenance/continuation chemotherapy**
- For guidance regarding if and when a patient being treated on or according to a
specific COG (or legacy group) protocol is eligible, please refer to ?AALL03N1
Eligibility by Protocol Tool,? available in the study data forms packet on the
COG website
- Written informed consent from the patient and/or the patient?s legally authorized
guardian, obtained prior to registration and any study-related procedures, and in
accordance with institutional policies approved by the United States (U.S) Department
of Health and Human Services
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Minimum age
No limit
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients of multi-ethnic/multi-racial backgrounds are not eligible for this study;
while patients of multi-ethnic/multi-racial ancestry (e.g., Caucasian/Japanese,
Hawaiian/Puerto Rican) are not eligible, patients of mixed ancestry within a
race/ethnicity (e.g., Japanese/Chinese = Asian or Korean/Japanese/Hawaiian = Asian or
Mexican/Puerto Rican = Hispanic) may participate as long as they fall under the
general classification of "African-American," "Asian," "Caucasian," or "Hispanic"
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/05/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/06/2020
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Sample size
Target
720
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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6008 - Perth
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Recruitment outside Australia
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Alabama
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Arkansas
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California
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Colorado
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Delaware
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District of Columbia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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Summary
Brief summary
This clinical trial is assessing compliance with long-term mercaptopurine treatment in young
patients with acute lymphoblastic leukemia in remission. Assessing why young patients who
have acute lymphoblastic leukemia may not take their medications as prescribed may help
identify ways to assist them in taking their medications more consistently and may improve
long-term treatment outcomes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00268528
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Smita Bhatia
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Address
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Children's Oncology Group
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00268528
Download to PDF