Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00268528
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 720
• Locations: 135
• Actual Duration (Months): 181
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Acute Lymphoblastic Leukemia in Remission	Behavioral: Compliance Monitoring; Other: Laboratory Biomarker Analysis; Drug: Mercaptopurine; Drug: Methotrexate; Other: Questionnaire Administration; Other: Study of Socioeconomic and Demographic Variables

Detailed Description

PRIMARY OBJECTIVES:

1. To determine and compare adherence to maintenance mercaptopurine (6-MP) in a cohort of children with acute lymphoblastic leukemia (ALL) from four different ethnic and racial groups (Caucasians, African-Americans, Hispanics, and Asians) receiving maintenance/continuation chemotherapy, using the following assessments: serial red cell 6-MP metabolites (6-thioguanine [6TGN] and methyl thioinosine monophosphate [TIMP]); frequency of 6-MP dosing using an electronic pill monitoring system (Microelectromechanical Systems [MEMS]?); self-report of adherence to 6-MP by questionnaire.

2. To determine the impact of adherence to 6-MP (measured using 6TGN, methyl [Me]TIMP, MEMS? and self-report data independently) on event-free-survival (EFS) in the entire cohort, after adjusting for known predictors of disease outcome.

3. Define a critical level of adherence (measured independently by 6TGN, MeTIMP, MEMS?, self-report) that has a significant impact on EFS for the entire cohort.

4. Describe prevalence of adherence to 6-MP by ethnicity (6TGN, MeTIMP, MEMS?, Self-report).

5. Describe behavioral and socio-demographic predictors of adherence using the questionnaire data.

6. Describe the pill-taking practices in this cohort using the MEMS? data. VII. To evaluate the impact of adherence on ethnic/racial difference in EFS.

SECONDARY OBJECTIVES:

1. To assess the concordance among 6TGN and MeTIMP levels, electronic pill monitoring, and self-reported adherence in the ethnic/racial groups.

OUTLINE:

Patients receive an electronic pill monitoring system comprising an empty MEMS? medication bottle with TrackCap? child resistant (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 orally (PO) as indicated by their individual chemotherapy regimen.

NOTE: *Study closed to accrual for Caucasian and Hispanic patients as of 8/14/2009.

After completion of study, patients are followed up every 6 months for 5 years and then annually for up to 10 years.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 720 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Understanding the Ethnic and Racial Differences in Survival in Children With Acute Lymphoblastic Leukemia
• Actual Study Start Date: May 30, 2005
• Actual Primary Completion Date: Mar 5, 2012
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm

Intervention/Treatment

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.

Behavioral: Compliance Monitoring; Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap; Other: Laboratory Biomarker Analysis; Correlative studies; Drug: Mercaptopurine; Given PO; Other Names: 3H-Purine-6-thiol 6 MP 6 Thiohypoxanthine 6 Thiopurine 6-Mercaptopurine 6-Mercaptopurine Monohydrate 6-MP 6-Purinethiol 6-Thiopurine 6-Thioxopurine 6H-Purine-6-thione, 1,7-dihydro- (9CI) 7-Mercapto-1,3,4,6-tetrazaindene Alti-Mercaptopurine Azathiopurine BW 57-323H Flocofil Ismipur Leukerin Leupurin Mercaleukim Mercaleukin Mercaptina Mercaptopurinum Mercapurin Mern NCI-C04886 Puri-Nethol Purimethol Purine, 6-mercapto- Purine-6-thiol (8CI) Purine-6-thiol, monohydrate Purinethiol Purinethol U-4748 WR-2785 ; Drug: Methotrexate; Given PO; Other Names: Abitrexate Alpha-Methopterin Amethopterin Brimexate CL 14377 CL-14377 Emtexate Emthexat Emthexate Farmitrexat Fauldexato Folex Folex PFS Lantarel Ledertrexate Lumexon Maxtrex Medsatrexate Metex Methoblastin Methotrexate LPF Methotrexate Methylaminopterin Methotrexatum Metotrexato Metrotex Mexate Mexate-AQ MTX Novatrex Rheumatrex Texate Tremetex Trexeron Trixilem WR-19039 ; Other: Questionnaire Administration; Ancillary studies; Other: Study of Socioeconomic and Demographic Variables; Receive an electronic pill monitoring system comprising an empty MEMS medication bottle with TrackCap

Outcome Measures

Primary Outcome Measures

1. Adherence to 6-MP as measured by 6TGN and MethylTIMP levels [169 days]

   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.

2. 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 [Up to 169 days]

   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.

3. 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 [169 days]

   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.

4. EFS [Up to 10 years]

   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.

5. Critical level of adherence (measured independently by 6TGN/MethylTIMP, MEMS?, self-report) that has a significant impact on EFS [Up to 10 years]

   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.

6. Prevalence of adherence to 6-MP by ethnicity (measured independently by 6TGN/MethylTIMP, MEMS?, Self-report) that has a significant impact on EFS [Up to 10 years]

   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).

7. Behavioral, socio-demographic predictors of adherence using the questionnaire data [Up to 10 years]

   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).

8. Pill-taking practices using the MEMS? data [Up to 169 days]

   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.

9. Impact of adherence (measured independently by 6TGN/MethylTIMP, MEMS, self-report) on ethnic/racial differences in EFS [Up to 10 years]

   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.

Secondary Outcome Measures

1. Concordance among red cell thiopurine metabolite levels, electronic pill monitoring, and self-reported adherence among the ethnic/racial groups [Up to 168 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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"

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Alabama	Birmingham	Alabama	United States	35233
2	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	United States	35233
3	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
4	Kaiser Permanente Downey Medical Center	Downey	California	United States	90242
5	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010
6	Loma Linda University Medical Center	Loma Linda	California	United States	92354
7	Miller Children's and Women's Hospital Long Beach	Long Beach	California	United States	90806
8	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
9	Mattel Children's Hospital UCLA	Los Angeles	California	United States	90095
10	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California	United States	90095
11	Valley Children's Hospital	Madera	California	United States	93636
12	Children's Hospital and Research Center at Oakland	Oakland	California	United States	94609-1809
13	Lucile Packard Children's Hospital Stanford University	Palo Alto	California	United States	94304
14	University of California Davis Comprehensive Cancer Center	Sacramento	California	United States	95817
15	Rady Children's Hospital - San Diego	San Diego	California	United States	92123
16	UCSF Medical Center-Parnassus	San Francisco	California	United States	94143
17	Harbor-University of California at Los Angeles Medical Center	Torrance	California	United States	90502
18	Children's Hospital Colorado	Aurora	Colorado	United States	80045
19	University of Connecticut	Farmington	Connecticut	United States	06030
20	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
21	Yale University	New Haven	Connecticut	United States	06520
22	Alfred I duPont Hospital for Children	Wilmington	Delaware	United States	19803
23	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
24	Children's National Medical Center	Washington	District of Columbia	United States	20010
25	Lee Memorial Health System	Fort Myers	Florida	United States	33901
26	University of Florida Health Science Center - Gainesville	Gainesville	Florida	United States	32610
27	Memorial Regional Hospital/Joe DiMaggio Children's Hospital	Hollywood	Florida	United States	33021
28	Nemours Children's Clinic-Jacksonville	Jacksonville	Florida	United States	32207
29	University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	United States	33136
30	Miami Cancer Institute	Miami	Florida	United States	33176
31	AdventHealth Orlando	Orlando	Florida	United States	32803
32	Nemours Children's Clinic - Orlando	Orlando	Florida	United States	32806
33	Nemours Children's Clinic - Pensacola	Pensacola	Florida	United States	32504
34	Sacred Heart Hospital	Pensacola	Florida	United States	32504
35	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida	United States	33701
36	Saint Joseph's Hospital/Children's Hospital-Tampa	Tampa	Florida	United States	33607
37	Children's Healthcare of Atlanta - Egleston	Atlanta	Georgia	United States	30322
38	Augusta University Medical Center	Augusta	Georgia	United States	30912
39	University of Hawaii Cancer Center	Honolulu	Hawaii	United States	96813
40	Rush University Medical Center	Chicago	Illinois	United States	60612
41	University of Illinois	Chicago	Illinois	United States	60612
42	Loyola University Medical Center	Maywood	Illinois	United States	60153
43	Advocate Children's Hospital-Oak Lawn	Oak Lawn	Illinois	United States	60453
44	Advocate Lutheran General Hospital	Park Ridge	Illinois	United States	60068
45	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
46	Saint Vincent Hospital and Health Care Center	Indianapolis	Indiana	United States	46260
47	Blank Children's Hospital	Des Moines	Iowa	United States	50309
48	University of Kentucky/Markey Cancer Center	Lexington	Kentucky	United States	40536
49	Tulane University Health Sciences Center	New Orleans	Louisiana	United States	70112
50	Children's Hospital New Orleans	New Orleans	Louisiana	United States	70118
51	Eastern Maine Medical Center	Bangor	Maine	United States	04401
52	C S Mott Children's Hospital	Ann Arbor	Michigan	United States	48109
53	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan	United States	48201
54	Ascension Saint John Hospital	Detroit	Michigan	United States	48236
55	Hurley Medical Center	Flint	Michigan	United States	48503
56	Helen DeVos Children's Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
57	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
58	Children's Hospitals and Clinics of Minnesota - Minneapolis	Minneapolis	Minnesota	United States	55404
59	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota	United States	55455
60	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
61	University of Missouri - Ellis Fischel	Columbia	Missouri	United States	65212
62	Children's Mercy Hospitals and Clinics	Kansas City	Missouri	United States	64108
63	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
64	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
65	Nevada Cancer Research Foundation CCOP	Las Vegas	Nevada	United States	89106
66	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
67	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
68	Saint Barnabas Medical Center	Livingston	New Jersey	United States	07039
69	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
70	Saint Joseph's Regional Medical Center	Paterson	New Jersey	United States	07503
71	Overlook Hospital	Summit	New Jersey	United States	07902
72	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
73	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467
74	Brooklyn Hospital Center	Brooklyn	New York	United States	11201
75	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
76	NYU Winthrop Hospital	Mineola	New York	United States	11501
77	Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York	United States	10016
78	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
79	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
80	State University of New York Upstate Medical University	Syracuse	New York	United States	13210
81	New York Medical College	Valhalla	New York	United States	10595
82	Mission Hospital Inc-Memorial Campus	Asheville	North Carolina	United States	28801
83	Novant Health Presbyterian Medical Center	Charlotte	North Carolina	United States	28204
84	Duke University Medical Center	Durham	North Carolina	United States	27710
85	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
86	Children's Hospital Medical Center of Akron	Akron	Ohio	United States	44308
87	Rainbow Babies and Childrens Hospital	Cleveland	Ohio	United States	44106
88	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
89	Dayton Children's Hospital	Dayton	Ohio	United States	45404
90	The Toledo Hospital/Toledo Children's Hospital	Toledo	Ohio	United States	43606
91	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
92	Natalie Warren Bryant Cancer Center at Saint Francis	Tulsa	Oklahoma	United States	74136
93	Legacy Emanuel Hospital and Health Center	Portland	Oregon	United States	97227
94	Lehigh Valley Hospital - Muhlenberg	Bethlehem	Pennsylvania	United States	18017
95	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
96	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
97	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15224
98	Rhode Island Hospital	Providence	Rhode Island	United States	02903
99	Prisma Health Richland Hospital	Columbia	South Carolina	United States	29203
100	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
101	T C Thompson Children's Hospital	Chattanooga	Tennessee	United States	37403
102	East Tennessee Childrens Hospital	Knoxville	Tennessee	United States	37916
103	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee	United States	37232
104	Texas Tech University Health Sciences Center-Amarillo	Amarillo	Texas	United States	79106
105	Dell Children's Medical Center of Central Texas	Austin	Texas	United States	78723
106	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78411
107	Medical City Dallas Hospital	Dallas	Texas	United States	75230
108	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	United States	75390
109	Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas	United States	77030
110	Covenant Children's Hospital	Lubbock	Texas	United States	79410
111	Methodist Children's Hospital of South Texas	San Antonio	Texas	United States	78229
112	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
113	Scott and White Memorial Hospital	Temple	Texas	United States	76508
114	Primary Children's Hospital	Salt Lake City	Utah	United States	84113
115	University of Vermont and State Agricultural College	Burlington	Vermont	United States	05405
116	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
117	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
118	Seattle Children's Hospital	Seattle	Washington	United States	98105
119	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington	United States	99204
120	Madigan Army Medical Center	Tacoma	Washington	United States	98431
121	West Virginia University Charleston Division	Charleston	West Virginia	United States	25304
122	Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin	United States	54301
123	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	United States	54449
124	Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53226
125	Princess Margaret Hospital for Children	Perth	Western Australia	Australia	6008
126	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2B7
127	British Columbia Children's Hospital	Vancouver	British Columbia	Canada	V6H 3V4
128	IWK Health Centre	Halifax	Nova Scotia	Canada	B3K 6R8
129	Kingston Health Sciences Centre	Kingston	Ontario	Canada	K7L 2V7
130	Children's Hospital	London	Ontario	Canada	N6A 5W9
131	Victoria Hospital	London	Ontario	Canada	N6K 1C2
132	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8
133	The Montreal Children's Hospital of the MUHC	Montreal	Quebec	Canada	H3H 1P3
134	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1
135	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Smita Bhatia, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT00268528
• Other Study ID Numbers: AALL03N1; NCI-2009-00305; CDR0000459748; 07-462; AALL03N1; COG-AALL03N1; AALL03N1; R01CA096670; U10CA095861
• First Posted: Dec 22, 2005
• Last Update Posted: Jul 7, 2020
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Methotrexate; Mercaptopurine

Study Results

No Results Posted as of Jul 7, 2020