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Assessing Compliance With Mercaptopurine Treatment in Younger Patients With Acute Lymphoblastic Leukemia in First Remission

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Childhood Acute Lymphoblastic Leukemia in Remission

Intervention: behavioral intervention (Behavioral); mercaptopurine (Drug); standard follow-up care (Procedure); compliance monitoring (Behavioral); questionnaire administration (Other); laboratory biomarker analysis (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Smita Bhatia, MD, MPH, Principal Investigator, Affiliation: Children's Oncology Group


This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.

Clinical Details

Official title: A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by MEMS®

Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by red cell TGN levels

Secondary outcome:

Proportion of adherence patients by sociodemographic and psychosocial variables

Mediating effect of health beliefs/ knowledge on change in adherence with intervention

Impact of IP vs. EDU on risk of relapse in children with ALL

Detailed description: PRIMARY OBJECTIVES: I. Determine the impact of interventions proposed in intervention program (IP) vs. education alone (EDU) on adherence to oral 6MP (mercaptopurine) in children with acute lymphoblastic leukemia (ALL). Adherence will be measured by: i) Medication Event Monitoring Systems (MEMS) (primary measure of adherence to oral 6MP, providing real-time data; ii) red cell thioguanine nucleotide (TGN) levels (providing data on chronic, systemic 6MP exposure). SECONDARY OBJECTIVES: I. Examine the modifying effect of sociodemographic and psychosocial variables, and the mediating effect of health beliefs/ knowledge on change in adherence with intervention. II. Determine impact of IP vs. EDU on risk of relapse of ALL. OUTLINE: Patients are randomized to 1 of 2 intervention arms. ARM I: Patients receive the Patients Supply Kit containing an electronic pill monitoring system, a MEMS® medication bottle with TrackCap™ with standard resistant cap, and written instructions for the patient and pharmacist. Parents and/or caregivers are also trained to supervise patients' intake of the medication. Beginning on day 1, patients start using the MEMS® medication bottle with TrackCap™. Clinical research assistants contact patients and parents by telephone the next day to confirm that TrackCap™ is being used, to identify any obstacles, and to determine solutions. Beginning on day 29, patients and caregivers view an interactive multimedia educational program on-line or via DVD. Patients also receive a customized electronic mercaptopurine schedule and automated customized text message reminders delivered via cellular phone or web-based interface. Patients and caregivers are instructed to return the MEMS® medication bottle with TrackCap™ to the clinic by day 141. ARM II: Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. After completion of study treatment, patients are followed up every 6 months for 5 years and then annually until 10 years from diagnosis.


Minimum age: 1 Year. Maximum age: 21 Years. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of ALL, in first remission; enrollment on a Children Oncology Group (COG)

therapeutic study for ALL is not required

- At the time of enrollment, patient must have completed at least 24 weeks of

maintenance chemotherapy, and is scheduled to receive at least 24 more weeks of maintenance chemotherapy

- Receiving continuous oral 6MP during the maintenance phase of therapy for ALL (held

only for toxicity or illness), and will be returning to the clinic every 4 weeks for scheduled appointments while enrolled on COG ACCL1033 (between days 1 and 141)

- Has a designated parent or caregiver who is willing to enter into a mutual agreement

with the patient to participate in a daily supervised medication administration routine

- Able and willing to use the MEMS® TrackCap™ (e. g., not using a pillbox or prescribed

liquid 6MP)

- Parent/caregiver and patient (if 12 years and older) must be willing to use a

cellular telephone to receive medication reminders via text messaging during study period

- Patient and parent/caregiver must speak English or Spanish

- All patients and/or their parents or legal guardians must sign a written informed


- All institutional, Food and Drug Administration (FDA), and National Cancer Institute

(NCI) requirements for human studies must be met Exclusion Criteria:

- Patients with Down syndrome

- Patients who previously participated in or are currently participating in another

intervention clinical trial designed to improve adherence

Locations and Contacts

Children's Hospital of Alabama, Birmingham, Alabama 35233, United States; Recruiting
Alyssa T. Reddy, Phone: 205-934-0309
Alyssa T. Reddy, Principal Investigator

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Alyssa T. Reddy, Phone: 205-934-0309
Alyssa T. Reddy, Principal Investigator

Southern California Permanente Medical Group, Downey, California 90242, United States; Recruiting
Robert M. Cooper, Phone: 626-564-3455
Robert M. Cooper, Principal Investigator

City of Hope, Duarte, California 91010, United States; Recruiting
Smita Bhatia, MD, MPH, Phone: 626-471-7321, Email: sbhatia@coh.org
Smita Bhatia, MD, MPH, Principal Investigator

Miller Children's Hospital, Long Beach, California 90806, United States; Recruiting
Amanda M. Termuhlen, Phone: 562-933-5437
Amanda M. Termuhlen, Principal Investigator

Children's Hospital Los Angeles, Los Angeles, California 90027, United States; Recruiting
Leo Mascarenhas, Phone: 323-361-4110
Leo Mascarenhas, Principal Investigator

Mattel Children's Hospital UCLA, Los Angeles, California 90095, United States; Recruiting
Pamela H. Kempert, Phone: 310-825-6708
Pamela H. Kempert, Principal Investigator

Lucile Packard Children's Hospital Stanford University, Palo Alto, California 94304, United States; Recruiting
Neyssa M. Marina, Phone: 650-498-7061, Email: clinicaltrials@med.stanford.edu
Neyssa M. Marina, Principal Investigator

Rady Children's Hospital - San Diego, San Diego, California 92123, United States; Recruiting
William D. Roberts, Phone: 858-966-5934
William D. Roberts, Principal Investigator

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Recruiting
Michael S. Isakoff, Phone: 860-545-9981
Michael S. Isakoff, Principal Investigator

Alfred I duPont Hospital for Children, Wilmington, Delaware 19803, United States; Recruiting
Christopher N. Frantz, Phone: 302-651-5755
Christopher N. Frantz, Principal Investigator

Children's National Medical Center, Washington, District of Columbia 20010, United States; Recruiting
Jeffrey S. Dome, Phone: 202-884-2549
Jeffrey S. Dome, Principal Investigator

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida 33908, United States; Recruiting
Emad K. Salman, Phone: 239-343-5333
Emad K. Salman, Principal Investigator

Lee Memorial Health System, Fort Myers, Florida 33901, United States; Withdrawn

University of Florida, Gainesville, Florida 32610, United States; Recruiting
William B. Slayton, Phone: 352-273-8675, Email: trials@cancer.ufl.edu
William B. Slayton, Principal Investigator

Memorial Healthcare System - Joe DiMaggio Children's Hospital, Hollywood, Florida 33021, United States; Recruiting
Iftikhar Hanif, Phone: 954-265-2234
Iftikhar Hanif, Principal Investigator

Nemours Children's Clinic - Jacksonville, Jacksonville, Florida 32207, United States; Recruiting
Eric S. Sandler, Phone: 904-697-3529
Eric S. Sandler, Principal Investigator

Nemours Children's Clinic - Orlando, Orlando, Florida 32806, United States; Withdrawn

Nemours Children's Hospital, Orlando, Florida 32827, United States; Recruiting
Ramamoorthy Nagasubramanian, Phone: 407-650-7150
Ramamoorthy Nagasubramanian, Principal Investigator

Nemours Children's Clinic - Pensacola, Pensacola, Florida 32504, United States; Recruiting
Jeffrey H. Schwartz, Phone: 904-697-3529
Jeffrey H. Schwartz, Principal Investigator

All Children's Hospital, Saint Petersburg, Florida 33701, United States; Recruiting
Gregory A. Hale, Phone: 727-767-2423, Email: HamblinF@allkids.org
Gregory A. Hale, Principal Investigator

Saint Joseph Children's Hospital of Tampa, Tampa, Florida 33607, United States; Recruiting
Hardeo K. Panchoosingh, Phone: 800-882-4123
Hardeo K. Panchoosingh, Principal Investigator

Tampa General Hospital, Tampa, Florida 33606, United States; Recruiting
Cameron K. Tebbi, Phone: 800-882-4123, Email: hkourtellis@tgh.org
Cameron K. Tebbi, Principal Investigator

Saint Mary's Hospital, West Palm Beach, Florida 33407, United States; Recruiting
Narayana Gowda, Phone: 888-823-5923, Email: ctsucontact@westat.com
Narayana Gowda, Principal Investigator

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia 30322, United States; Recruiting
Marla H. Daves, Phone: 404-778-1868, Email: burton@bcm.edu
Marla H. Daves, Principal Investigator

University of Hawaii, Honolulu, Hawaii 96813, United States; Recruiting
Robert W. Wilkinson, Phone: 808-983-6090
Robert W. Wilkinson, Principal Investigator

Lurie Children's Hospital-Chicago, Chicago, Illinois 60611, United States; Recruiting
Nobuko Hijiya, Phone: 773-880-4562
Nobuko Hijiya, Principal Investigator

University of Illinois, Chicago, Illinois 60612, United States; Recruiting
Mary L. Schmidt, Phone: 312-355-3046
Mary L. Schmidt, Principal Investigator

Advocate Lutheran General Hospital., Park Ridge, Illinois 60068, United States; Recruiting
Jong-Hyo Kwon, Phone: 847-384-3621
Jong-Hyo Kwon, Principal Investigator

Riley Hospital for Children, Indianapolis, Indiana 46202, United States; Recruiting
Robert J. Fallon, Phone: 317-274-2552
Robert J. Fallon, Principal Investigator

Saint Vincent Hospital and Health Services, Indianapolis, Indiana 46260, United States; Recruiting
Bassem I. Razzouk, Phone: 317-338-2194
Bassem I. Razzouk, Principal Investigator

Blank Children's Hospital, Des Moines, Iowa 50309, United States; Recruiting
Wendy L. Woods-Swafford, Phone: 515-241-6729
Wendy L. Woods-Swafford, Principal Investigator

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States; Recruiting
Ayman A. El-Sheikh, Phone: 800-237-1225
Ayman A. El-Sheikh, Principal Investigator

Ochsner Medical Center Jefferson, New Orleans, Louisiana 70121, United States; Recruiting
Craig Lotterman, Phone: 888-562-4763
Craig Lotterman, Principal Investigator

Tulane University Health Sciences Center, New Orleans, Louisiana 70112, United States; Withdrawn

C S Mott Children's Hospital, Ann Arbor, Michigan 48109, United States; Recruiting
Rama Jasty, Phone: 419-251-8210
Rama Jasty, Principal Investigator

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan 48201, United States; Recruiting
Jeffrey W. Taub, Phone: 313-576-9363
Jeffrey W. Taub, Principal Investigator

Hurley Medical Center, Flint, Michigan 48502, United States; Recruiting
Susumu Inoue, Phone: 888-606-6556
Susumu Inoue, Principal Investigator

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan 49503, United States; Recruiting
David S. Dickens, Phone: 616-267-1925
David S. Dickens, Principal Investigator

Beaumont Children's Hospital-Royal Oak, Royal Oak, Michigan 48073, United States; Terminated

William Beaumont Hospital-Royal Oak, Royal Oak, Michigan 48073, United States; Withdrawn

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota 55404, United States; Recruiting
Bruce C. Bostrom, Phone: 612-813-5193
Bruce C. Bostrom, Principal Investigator

University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota 55455, United States; Recruiting
Brenda J. Weigel, Phone: 612-624-2620
Brenda J. Weigel, Principal Investigator

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Carola A. Arndt, Phone: 507-538-7623
Carola A. Arndt, Principal Investigator

University of Mississippi Medical Center, Jackson, Mississippi 39216, United States; Recruiting
Gail C. Megason, Phone: 601-815-6700
Gail C. Megason, Principal Investigator

The Childrens Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Maxine L. Hetherington, Phone: 816-234-3265
Maxine L. Hetherington, Principal Investigator

Saint John's Mercy Medical Center, Saint Louis, Missouri 63141, United States; Recruiting
Bethany G. Sleckman, Phone: 913-948-5588
Bethany G. Sleckman, Principal Investigator

Children's Hospital and Medical Center of Omaha, Omaha, Nebraska 68114, United States; Recruiting
Minnie Abromowitch, Phone: 402-955-3949
Minnie Abromowitch, Principal Investigator

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States; Recruiting
Peter F. Coccia, Phone: 800-999-5465
Peter F. Coccia, Principal Investigator

Children's Specialty Center of Nevada II, Las Vegas, Nevada 89109, United States; Recruiting
Jonathan Bernstein, Phone: 702-384-0013
Jonathan Bernstein, Principal Investigator

Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada 89106, United States; Recruiting
Jonathan Bernstein, Phone: 702-384-0013
Jonathan Bernstein, Principal Investigator

Summerlin Hospital Medical Center, Las Vegas, Nevada 89144, United States; Recruiting
Jonathan Bernstein, Phone: 702-384-0013
Jonathan Bernstein, Principal Investigator

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Recruiting
Burton E. Appel, Phone: 201-996-2879
Burton E. Appel, Principal Investigator

Morristown Memorial Hospital, Morristown, New Jersey 07962, United States; Recruiting
Steven L. Halpern, Phone: 973-971-5900
Steven L. Halpern, Principal Investigator

Overlook Hospital, Summit, New Jersey 07902, United States; Recruiting
Steven L. Halpern, Phone: 973-971-5900
Steven L. Halpern, Principal Investigator

University of New Mexico, Albuquerque, New Mexico 87106, United States; Recruiting
Koh B. Boayue, Phone: 505-272-6972
Koh B. Boayue, Principal Investigator

Montefiore Medical Center - Moses Campus, Bronx, New York 10467-2490, United States; Recruiting
Peter D. Cole, Phone: 718-904-2730, Email: aecc@aecom.yu.edu
Peter D. Cole, Principal Investigator

Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Alice Lee, Phone: 212-305-8615
Alice Lee, Principal Investigator

New York University Langone Medical Center, New York, New York 10016, United States; Recruiting
Linda Granowetter, Phone: 212-263-4434, Email: prmc.coordinator@nyumc.org
Linda Granowetter, Principal Investigator

New York Medical College, Valhalla, New York 10595, United States; Recruiting
Mehmet F. Ozkaynak, Phone: 914-594-3794
Mehmet F. Ozkaynak, Principal Investigator

Mission Hospital-Memorial Campus, Asheville, North Carolina 28801, United States; Recruiting
Douglas J. Scothorn, Phone: 828-213-4150
Douglas J. Scothorn, Principal Investigator

Novant Health Presbyterian Medical Center, Charlotte, North Carolina 28204, United States; Active, not recruiting

Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Susan G. Kreissman, Phone: 888-275-3853
Susan G. Kreissman, Principal Investigator

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
Sharon M. Castellino, Phone: 336-713-6771
Sharon M. Castellino, Principal Investigator

Children's Hospital Medical Center of Akron, Akron, Ohio 44308, United States; Recruiting
Steven J. Kuerbitz, Phone: 330-543-3193
Steven J. Kuerbitz, Principal Investigator

Rainbow Babies and Childrens Hospital, Cleveland, Ohio 44106, United States; Recruiting
Yousif (Joe) H. Matloub, Phone: 216-844-5437
Yousif (Joe) H. Matloub, Principal Investigator

Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Recruiting
Mark A. Ranalli, Phone: 614-722-2708
Mark A. Ranalli, Principal Investigator

Dayton Children's Hospital, Dayton, Ohio 45404, United States; Recruiting
Emmett H. Broxson, Phone: 800-228-4055
Emmett H. Broxson, Principal Investigator

Mercy Children's Hospital, Toledo, Ohio 43608, United States; Recruiting
Rama Jasty, Phone: 419-251-8210
Rama Jasty, Principal Investigator

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Rene Y. McNall-Knapp, Phone: 405-271-4272, Email: julie-traylor@ouhsc.edu
Rene Y. McNall-Knapp, Principal Investigator

Legacy Emanuel Children's Hospital, Portland, Oregon 97227, United States; Recruiting
Janice F. Olson, Phone: 503-413-2560
Janice F. Olson, Principal Investigator

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Active, not recruiting

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15224, United States; Recruiting
Peter H. Shaw, Phone: 412-692-5573
Peter H. Shaw, Principal Investigator

Palmetto Health Richland, Columbia, South Carolina 29203, United States; Recruiting
Ronnie W. Neuberg, Phone: 803-434-3680
Ronnie W. Neuberg, Principal Investigator

Dell Children's Medical Center of Central Texas, Austin, Texas 78723, United States; Recruiting
Sharon K. Lockhart, Phone: 512-324-8022
Sharon K. Lockhart, Principal Investigator

Driscoll Children's Hospital, Corpus Christi, Texas 78411, United States; Recruiting
M. C. Johnson, Phone: 361-694-5311
M. C. Johnson, Principal Investigator

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States; Recruiting
Naomi J. Winick, Phone: 214-648-7097
Naomi J. Winick, Principal Investigator

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229, United States; Recruiting
Jaime Estrada, Phone: 210-575-7000
Jaime Estrada, Principal Investigator

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States; Recruiting
Anne-Marie R. Langevin, Phone: 210-567-0653, Email: che@uthscsa.edu
Anne-Marie R. Langevin, Principal Investigator

Carilion Clinic Children's Hospital, Roanoke, Virginia 24014, United States; Recruiting
Mandy M. Atkinson, Phone: 540-981-7376
Mandy M. Atkinson, Principal Investigator

Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting
Douglas S. Hawkins, Phone: 866-987-2000
Douglas S. Hawkins, Principal Investigator

Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington 99204, United States; Recruiting
Judy L. Felgenhauer, Phone: 800-228-6618, Email: HopeBeginsHere@providence.org
Judy L. Felgenhauer, Principal Investigator

Saint Vincent Hospital, Green Bay, Wisconsin 54301, United States; Recruiting
Smita Bhatia, Phone: 800-826-4673, Email: becomingapatient@coh.org
Smita Bhatia, Principal Investigator

Additional Information

Starting date: February 2012
Last updated: February 23, 2015

Page last updated: August 23, 2015

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