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Anti-metabolites
Mercaptopurine Compliance for Leukemia
Phase 3
Waitlist Available
Led By Smita Bhatia
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Patient and parent/caregiver must speak English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing a new way to help patients with leukemia take their medication, to see if it improves treatment outcomes.
Who is the study for?
This trial is for young patients with Acute Lymphoblastic Leukemia in first remission who've completed at least 24 weeks of maintenance chemo and will continue for another 24. They must take oral Mercaptopurine, have a caregiver to help with medication routines, be willing to use text reminders, and speak English or Spanish. It's not for those with Down syndrome or enrolled in other adherence trials.Check my eligibility
What is being tested?
The study tests if a special intervention helps young leukemia patients stick to their Mercaptopurine treatment better than the usual care does. This includes monitoring compliance using caps that track when the medicine bottle is opened and sending text message reminders.See study design
What are the potential side effects?
While this trial focuses on compliance rather than drug effects, Mercaptopurine can cause side effects like liver problems, low blood cell counts leading to infection risk, nausea, vomiting, and rash.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have completed 24 weeks of ongoing cancer treatment and will continue for at least another 24 weeks.
Select...
I, and my caregiver if applicable, can communicate in English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mercaptopurine
Mercaptopurine
Secondary outcome measures
Impact of IP vs. EDU on risk of relapse in children with ALL
Mediating effect of health beliefs/ knowledge on change in adherence with intervention
Proportion of adherence patients by sociodemographic and psychosocial variables
Side effects data
From 2021 Phase 3 trial • 3154 Patients • NCT0007572582%
Neutrophil count decreased
68%
Infections and infestations - Other, specify
65%
Febrile neutropenia
46%
Alanine aminotransferase increased
45%
White blood cell decreased
38%
Platelet count decreased
33%
Anemia
26%
Aspartate aminotransferase increased
20%
Hypokalemia
14%
Anaphylaxis
13%
Mucositis oral
13%
Hyponatremia
12%
Hyperglycemia
12%
Diarrhea
10%
Dehydration
10%
Lymphocyte count decreased
10%
Anorexia
9%
Upper respiratory infection
8%
Abdominal pain
8%
Vomiting
7%
Lung infection
7%
Blood bilirubin increased
7%
Fever
7%
Hypocalcemia
7%
Enterocolitis infectious
5%
Catheter related infection
5%
Hypoxia
5%
Lipase increased
5%
Peripheral motor neuropathy
5%
Serum amylase increased
5%
Hypoalbuminemia
4%
Peripheral sensory neuropathy
4%
Urinary tract infection
4%
Otitis media
4%
Fibrinogen decreased
3%
Sinusitis
3%
Colitis
3%
Skin infection
3%
Pneumonitis
3%
Rash maculo-papular
3%
Activated partial thromboplastin time prolonged
3%
Pancreatitis
3%
Typhlitis
3%
Hypoglycemia
3%
Hypophosphatemia
3%
Hypotension
3%
Nausea
2%
Respiratory, thoracic and mediastinal disorders - Other, specify
2%
Constipation
2%
Ileus
2%
Seizure
2%
GGT increased
2%
Hypertension
2%
Pain
2%
Tumor lysis syndrome
2%
Weight loss
2%
Hyperkalemia
2%
Pleural effusion
1%
Buttock pain
1%
Portal hypertension
1%
Conjunctivitis infective
1%
Depressed level of consciousness
1%
Agitation
1%
Pain in extremity
1%
Nervous system disorders - Other, specify
1%
Upper gastrointestinal hemorrhage
1%
Gastrointestinal disorders - Other, specify
1%
Disseminated intravascular coagulation
1%
Gait disturbance
1%
Epistaxis
1%
Ascites
1%
Anxiety
1%
Bronchial infection
1%
Arthralgia
1%
Blood and lymphatic system disorders - Other, specify
1%
Depression
1%
Fatigue
1%
Flu like symptoms
1%
Rectal pain
1%
Headache
1%
Insomnia
1%
Oral pain
1%
Sepsis
1%
Vascular disorders - Other, specify
1%
Hyperuricemia
1%
Cough
1%
Device related infection
1%
Enterocolitis
1%
Esophagitis
1%
Hypercalcemia
1%
Middle ear inflammation
1%
Immune system disorders - Other, specify
1%
Investigations - Other, specify
1%
Neuralgia
1%
Stomach pain
1%
Thromboembolic event
1%
Weight gain
1%
Wound infection
1%
Cardiac disorders - Other, specify
1%
Creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Prednisone, Capezzi Methotrexate >= 10 Years
Prednisone and High Dose Methotrexate < 10 Yrs Old
Prednisone and High Dose Methotrexate (Non Randomly Assigned)
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Prednisone, Capizzi Methotrexate <10 Years
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Prednisone and High Dose Methotrexate >=10 Years
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)
Prednisone, Capezzi Methotrexate (Down's Syndrome)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (intervention program and mercaptopurine)Experimental Treatment5 Interventions
See detailed description.
Group II: Arm II (standard of care and mercaptopurine)Active Control5 Interventions
Patients receive the usual standard of care and the mercaptopurine from the MEMS® medication bottle with TrackCap™ as patients in arm I. Patients and caregivers also view an interactive multimedia educational program on day 29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Compliance Monitoring
2005
N/A
~840
Mercaptopurine
2012
Completed Phase 4
~12330
Behavioral Intervention
2021
Completed Phase 4
~3740
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,370 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,929,801 Total Patients Enrolled
Smita BhatiaPrincipal InvestigatorChildren's Oncology Group
3 Previous Clinical Trials
9,605 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have Down syndrome.I have ALL and am in my first remission.I have completed 24 weeks of ongoing cancer treatment and will continue for at least another 24 weeks.I am taking 6MP for ALL and will visit the clinic every 4 weeks as part of COG ACCL1033.I, and my caregiver if applicable, can communicate in English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (standard of care and mercaptopurine)
- Group 2: Arm I (intervention program and mercaptopurine)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Mercaptopurine have a history of being studied in clinical trials?
"The first study of mercaptopurine happened in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. To date, there have been 776 completed clinical trials. Right now, there are 45 active clinical trials, a significant number of which are taking place in San Antonio, Texas."
Answered by AI
Has Mercaptopurine undergone Food and Drug Administration approval?
"Mercaptopurine is estimated to be a safe drug, as it has gone through multiple rounds of testing with Phase 3 trials."
Answered by AI
Could you please tell me how many different locations this trial is running in?
"You can find a list of the 100 active clinical sites for this trial on the website. They are located all over, including in San Antonio, Royal Oak and Pittsburgh, to name a few. If you decide to enroll, you should pick a location that is close to you to cut down on travel."
Answered by AI
Is this research currently recruiting participants?
"This specific trial is not looking for any more patients at the moment, however that doesn't mean other trials aren't. According to the latest information on clinicaltrials.gov, this trial was last edited on 6/8/2022 and 1586 other trials are still open."
Answered by AI
Are participants in this study required to be a certain age?
"If you meet the age requirements of 1-21 years old, then you may be eligible to participate in this clinical trial."
Answered by AI
How many people are total are participating in this trial?
"This study has reached its patient quota and is no longer recruiting. The trial was initially posted on February 21st, 2012 and was edited for the last time on June 8th, 2022. If you are looking for other trials, there are currently 1541 trials for leukemia and 45 trials for Mercaptopurine that are still enrolling patients."
Answered by AI
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