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Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL


N/A
N/A
21 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL


OBJECTIVES:

Primary

- Determine and compare adherence to maintenance mercaptopurine using the following
assessments: serial red cell mercaptopurine metabolites (i.e., 6TGN and methylTIMP),
frequency of mercaptopurine dosing using an electronic pill monitoring system (MEMS^®),
and self-report of adherence to mercaptopurine by questionnaire in a cohort of younger
patients with acute lymphoblastic leukemia in first remission who belong to four
different ethnic and racial groups (Caucasians, African-Americans, Hispanics, and
Asians).

- Determine the impact of adherence to mercaptopurine on event-free-survival (EFS) in the
entire cohort, after adjusting for known predictors of disease outcome.

- Define a critical level of adherence that has a significant impact on EFS for the
entire cohort.

- Describe prevalence of adherence to mercaptopurine by ethnicity.

- Describe behavioral and sociodemographic predictors of adherence.

- Describe the pill-taking practices in this cohort.

- Evaluate the impact of adherence on ethnic/racial difference in EFS.

Secondary

- Assess the concordance among 6TGN and methylTIMP levels, electronic pill monitoring,
and self-reported adherence in the ethnic/racial groups.

OUTLINE: This is a multicenter study.

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 6 months. The MEMS^® TrackCap™ CR is mailed to the study center at the end
of study. Patients also receive oral methotrexate as indicated by their individual
chemotherapy regimen.

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

Blood samples are collected on days 1, 29, 57, 85, 113, 141, and 169. Patient or caregiver
completes demographic questionnaire on day 29. Patient and/or caregiver completes a
self-reported adherence questionnaire on days 29, 57, 113, and 141.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 720 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of acute lymphoblastic leukemia (ALL) at ≤ 21 years of age

- Disease in first remission

- Receiving self- or parent/caregiver-administered oral antimetabolite chemotherapy
during the maintenance phase of therapy

- Has completed at least two courses* of maintenance chemotherapy, and is
scheduled to receive at least two more planned courses of maintenance
chemotherapy NOTE: *A course is defined as 12 weeks/84 days of maintenance
chemotherapy.

- Treatment plan must include oral mercaptopurine (6-MP) at 75 mg/m^2/day and
oral methotrexate at 20 mg/m^2/week during the maintenance phase

- Dose modification of 6-MP or methotrexate based on laboratory or
clinical parameters is acceptable

PATIENT CHARACTERISTICS:

- Belongs to one of the four following ethnic/racial categories: African-American,
Asian, Caucasian*, or Hispanic* NOTE: Closed to accrual for Caucasian and Hispanic
patients as of 8/14/2009.

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Concurrent enrollment on another therapeutic study for ALL allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Smita Bhatia, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

Unspecified

Study ID:

CDR0000459748

NCT ID:

NCT00268528

Start Date:

May 2005

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
Rush University Medical CenterChicago, Illinois  60612-3824
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
University of California Davis Cancer CenterSacramento, California  95817
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Driscoll Children's HospitalCorpus Christi, Texas  78466
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Brookdale University Hospital and Medical CenterBrooklyn, New York  11212
Brooklyn Hospital CenterBrooklyn, New York  11201
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Covenant Children's HospitalLubbock, Texas  79410
Midwest Children's Cancer Center at Children's Hospital of WisconsinMilwaukee, Wisconsin  53226
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Overlook HospitalSummit, New Jersey  07902-0220
Winthrop University HospitalMineola, New York  11501
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Blank Children's HospitalDes Moines, Iowa  50309
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Toledo HospitalToledo, Ohio  43606
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Childrens Hospital Los AngelesLos Angeles, California  90027
Children's Hospital and Research Center OaklandOakland, California  94609
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Children's Hospital Center for Cancer and Blood DisordersAurora, Colorado  80045
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Keyser Family Cancer Center at Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
St. Barnabas Medical Center Cancer CenterLivingston, New Jersey  07039
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Maimonides Cancer Center at Maimonides Medical CenterBrooklyn, New York  11219
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Akron Children's HospitalAkron, Ohio  44308-1062
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Dayton Children's - DaytonDayton, Ohio  45404-1815
Tod Children's HospitalYoungstown, Ohio  44501
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central TexasAustin, Texas  78723
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Madigan Army Medical Center - TacomaTacoma, Washington  98431
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Lehigh Valley Hospital - MuhlenbergBethlehem, Pennsylvania  18017
T.C. Thompson Children's HospitalChattanooga, Tennessee  37403
Connecticut Children's Medical CenterHartford, Connecticut  06106
Nemours Children's Clinic - PensacolaPensacola, Florida  32504
Helen DeVos Children's Hospital at Spectrum HealthGrand Rapids, Michigan  49503