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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
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
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 below
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I have ALL and am in my first remission.
Select...
I have completed 24 weeks of ongoing cancer treatment and will continue for at least another 24 weeks.
Select...
I am taking 6MP for ALL and will visit the clinic every 4 weeks as part of COG ACCL1033.
Select...
I, and my caregiver if applicable, can communicate in English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

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 • NCT00075725
74%
Neutrophil count decreased
48%
Infections and infestations - Other, specify
47%
Febrile neutropenia
46%
Alanine aminotransferase increased
38%
Platelet count decreased
36%
White blood cell decreased
28%
Anemia
26%
Hyperglycemia
24%
Aspartate aminotransferase increased
21%
Hypokalemia
16%
Blood bilirubin increased
16%
Mucositis oral
14%
Anaphylaxis
13%
Hyponatremia
12%
Headache
12%
Vomiting
10%
Dehydration
9%
Peripheral motor neuropathy
8%
Nausea
8%
Lung infection
8%
Hypocalcemia
6%
Lymphocyte count decreased
6%
Back pain
6%
Avascular necrosis
6%
Diarrhea
6%
GGT increased
6%
Peripheral sensory neuropathy
6%
Abdominal pain
6%
Anorexia
6%
Lipase increased
5%
Hypoalbuminemia
5%
Skin infection
5%
Fibrinogen decreased
5%
Hypoxia
5%
Pain
4%
Hypotension
4%
Glucose intolerance
4%
Serum amylase increased
4%
Thromboembolic event
4%
Upper respiratory infection
4%
Catheter related infection
4%
Fever
4%
Pain in extremity
3%
Hyperkalemia
3%
Pancreatitis
3%
Urinary tract infection
3%
Activated partial thromboplastin time prolonged
3%
Constipation
3%
Dysphasia
3%
Enterocolitis infectious
3%
Weight loss
3%
Fatigue
3%
Arthralgia
2%
Encephalopathy
2%
Investigations - Other, specify
2%
Depression
2%
Bone pain
2%
Acidosis
2%
Acute kidney injury
2%
Anxiety
2%
Hypertriglyceridemia
2%
Seizure
2%
Oral pain
2%
Sepsis
2%
Pneumonitis
2%
Sinusitis
2%
Epistaxis
2%
Esophagitis
2%
Nervous system disorders - Other, specify
2%
Syncope
2%
Tumor lysis syndrome
2%
Typhlitis
2%
Hypertension
2%
Vascular access complication
2%
Hypophosphatemia
1%
Dizziness
1%
Facial nerve disorder
1%
Cough
1%
Pleural effusion
1%
Creatinine increased
1%
Neuralgia
1%
Otitis media
1%
Pharyngitis
1%
Psychosis
1%
Dysphagia
1%
Mucosal infection
1%
Adult respiratory distress syndrome
1%
Bronchial infection
1%
Agitation
1%
Blood and lymphatic system disorders - Other, specify
1%
Cholesterol high
1%
Colitis
1%
Depressed level of consciousness
1%
Dyspnea
1%
Generalized muscle weakness
1%
Rectal pain
1%
Hepatobiliary disorders - Other, specify
1%
Hyperuricemia
1%
Ileus
1%
INR increased
1%
Intracranial hemorrhage
1%
Meningitis
1%
Muscle weakness lower limb
1%
Myalgia
1%
Non-cardiac chest pain
1%
Obesity
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Personality change
1%
Urticaria
1%
Wound infection
1%
Appendicitis
1%
Pharyngolaryngeal pain
1%
Soft tissue infection
1%
Vasovagal reaction
1%
Allergic reaction
1%
Bladder infection
1%
Cholecystitis
1%
Confusion
1%
Gastritis
1%
Gastrointestinal disorders - Other, specify
1%
Hypermagnesemia
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Rash maculo-papular
1%
Anorectal infection
1%
Ataxia
1%
General disorders and administration site conditions - Other, specify
1%
Cardiac disorders - Other, specify
1%
Hepatitis viral
1%
Hypercalcemia
1%
Weight gain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prednisone and High Dose Methotrexate >=10 Years
Dexamethasone, High Dose Methotrexate (IM) < 10 Years
Prednisone and High Dose Methotrexate < 10 Yrs Old
Dexamethasone, High Dose Methotrexate (IM) >= 10 Years
Prednisone and High Dose Methotrexate (Non Randomly Assigned)
Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old
Prednisone, Capizzi Methotrexate <10 Years
Prednisone, Capezzi Methotrexate >= 10 Years
Dexamethasone and Capizzi Methotrexate Patients < 10 Years
Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)
Prednisone, Capezzi Methotrexate (Down's Syndrome)
Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)

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
453 Previous Clinical Trials
236,830 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,076 Total Patients Enrolled
Smita BhatiaPrincipal InvestigatorChildren's Oncology Group
3 Previous Clinical Trials
9,343 Total Patients Enrolled

Media Library

Mercaptopurine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT01503632 — Phase 3
Acute Lymphoblastic Leukemia Research Study Groups: Arm II (standard of care and mercaptopurine), Arm I (intervention program and mercaptopurine)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Mercaptopurine Highlights & Side Effects. Trial Name: NCT01503632 — Phase 3
Mercaptopurine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01503632 — Phase 3

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

What are some of the most common treatments that involve Mercaptopurine?

"Mercaptopurine is a medication used to treat leukemia, lymphoma, and other conditions such as autoimmune hepatitis and acute promyelocytic leukemia."

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
~44 spots leftby Mar 2025