Mercaptopurine Compliance for Leukemia

Not currently recruiting at 117 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Oncology Group

Must be taking: 6MP

Disqualifiers: Down syndrome, Other adherence trials

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how well young patients with acute lymphoblastic leukemia (ALL) adhere to their mercaptopurine medication routine. The researchers will compare a new intervention program with standard care to determine if it helps patients take their medication more consistently, potentially improving treatment outcomes. Participants must have ALL in remission, be undergoing maintenance chemotherapy, and be willing to use a special medication bottle and receive text reminders. The study seeks to make managing daily medication easier and more effective for these patients. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires you to continue taking mercaptopurine (6MP) during the study. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mercaptopurine is generally safe for treating acute lymphoblastic leukemia in both children and adults. The FDA has approved it for this purpose, indicating thorough testing for efficacy and safety. Studies have found that most patients tolerate mercaptopurine well. However, some side effects, such as low blood sugar in young children, may occur. Monitoring for these side effects during treatment is important. Overall, evidence supports the safe use of mercaptopurine for leukemia, but patients should discuss any possible side effects with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the mercaptopurine compliance strategies for leukemia because they aim to improve how patients stick to their medication regimen. Unlike traditional methods that rely solely on patient discipline, this approach uses a high-tech MEMS® medication bottle with TrackCap™ to accurately monitor medication usage. Additionally, the inclusion of an interactive multimedia educational program helps both patients and caregivers understand the importance of consistent medication intake. These innovations could lead to better treatment outcomes by ensuring patients take their medication as prescribed.

What evidence suggests that this trial's treatments could be effective for acute lymphoblastic leukemia?

Research has shown that mercaptopurine effectively treats acute lymphoblastic leukemia (ALL) in young patients. Studies have found that this drug can lead to good recovery and improved blood health in children. One study discovered that higher doses of mercaptopurine significantly extended the time children with ALL remained free of complications or cancer. In this trial, participants will receive mercaptopurine as part of their treatment regimen. Additionally, many patients adhere to their mercaptopurine treatment plan, suggesting that when taken as directed, it works well. Overall, mercaptopurine plays a crucial role in keeping young patients with ALL in remission. ^{6 7 8 9 10}

Who Is on the Research Team?

Smita Bhatia

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

You have Down syndrome.

Patients who previously participated in or are currently participating in another intervention clinical trial designed to improve adherence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mercaptopurine treatment with adherence monitored using MEMS® medication bottle with TrackCap™ and educational interventions

4 months

Monthly visits for monitoring and education

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 6 months

Long-term follow-up

Annual monitoring until 10 years from diagnosis

5 additional years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Compliance Monitoring
• Mercaptopurine

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm I (intervention program and mercaptopurine) Experimental Treatment 5 Interventions

See detailed description.

Group II: Arm II (standard of care and mercaptopurine) Active Control 5 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.

Mercaptopurine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Purinethol for:

• Acute lymphoblastic leukemia (ALL)
• Chronic myeloid leukemia (CML)
• Crohn's disease
• Ulcerative colitis

Approved in European Union as Purinethol for:

• Acute lymphoblastic leukemia (ALL)
• Chronic myeloid leukemia (CML)
• Crohn's disease
• Ulcerative colitis

Approved in Canada as Purinethol for:

• Acute lymphoblastic leukemia (ALL)
• Chronic myeloid leukemia (CML)
• Crohn's disease
• Ulcerative colitis

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A survey of 49 parents and 15 adolescents with pediatric acute lymphoblastic leukemia (ALL) showed that all participants had access to mobile technology, indicating a strong potential for mobile health (mHealth) interventions to improve medication adherence.

Both parents and adolescents expressed a high interest in specific mHealth app features, such as medication lists, refill reminders, and reminders to take 6-mercaptopurine (6-MP), highlighting the need for tailored digital tools to support adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to Technology and Preferences for an mHealth Intervention to Promote Medication Adherence in Pediatric Acute Lymphoblastic Leukemia: Approach Leveraging Behavior Change Techniques. Heneghan, MB., Hussain, T., Barrera, L., et al.[2021]

A risk prediction model was developed using data from 407 children with acute lymphoblastic leukemia (ALL) to identify those at high risk for poor adherence to mercaptopurine (6MP), which is crucial for preventing relapse; the model showed good accuracy with AUCs of 0.79 and 0.74 in training and test sets, respectively.

Children identified as having a high probability of nonadherence had a 2.2-fold increased risk of relapse, highlighting the importance of this model in personalizing interventions to improve adherence and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual prediction of nonadherence to oral mercaptopurine in children with acute lymphoblastic leukemia: Results from COG AALL03N1. Hoppmann, AL., Chen, Y., Landier, W., et al.[2022]

A multicomponent intervention including education and daily text message reminders did not significantly increase overall adherence rates to mercaptopurine treatment in children with acute lymphoblastic leukemia (ALL), with adherence rates of 65% in the intervention group compared to 59% in the education-only group.

However, the intervention was effective in improving adherence among adolescents aged 12 years and older, particularly those with low baseline adherence, suggesting that targeted strategies may be beneficial for this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Daily Text Messaging and Directly Supervised Therapy Intervention on Oral Mercaptopurine Adherence in Children With Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. Bhatia, S., Hageman, L., Chen, Y., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39832489/

Adherence to 6-Mercaptopurine (6-MP) and Habit Strength in ...

Results: 81% (42/52) of participants reported high 6-MP adherence (VASdose ≥ 95%): patients 91% (10/11), parents 78% (32/41). No significant ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00268528

NCT00268528 | Study to Assess Compliance With Long- ...

This clinical trial is assessing compliance with long-term mercaptopurine treatment in young patients with acute lymphoblastic leukemia in remission.

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ashpublications.org

ashpublications.org/blood/article-abstract/93/9/2817/266656

Prognostic Importance of 6-Mercaptopurine Dose Intensity in ...

We conclude that increased dose-intensity of oral 6MP is an important determinant of EFS in ALL, particularly among those children with a homozygous wild-type ...

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sciencedirect.com/science/article/pii/S000649712072238X

Clinical Evaluation of a New Antimetabolite, 6 ...

A new antimetabolite, 6-mercaptopurine, has been shown to produce good clinical and hematologic remissions in fifteen out of forty-five children with acute ...

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haematologica.org

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Does allopurinol enhance efficacy of acute lymphoblastic ...

In the last decade studies on small series of ALL patients have shown that adding allopurinol to 6-MP-based maintenance therapy increased TGN ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/009053s040lbl.pdf

PURINETHOL (mercaptopurine) Label - accessdata.fda.gov

Safety and effectiveness of PURINETHOL has been established in pediatric patients. Use of PURINETHOL in pediatrics is supported by evidence from the ...

7.

mayoclinic.org

mayoclinic.org/drugs-supplements/mercaptopurine-oral-route/description/drg-20064683

Mercaptopurine (oral route) - Side effects & dosage

Safety and efficacy have not been established. The oral liquid may cause hypoglycemia (low blood sugar) in children younger than 6 years of age ...

8.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK557620/

Mercaptopurine - StatPearls - NCBI Bookshelf

Mercaptopurine (6MP) was approved by the Food and Drug Administration (FDA) for use in acute lymphoblastic leukemia in children and adults as ...

9.

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go.drugbank.com/drugs/DB01033

Mercaptopurine: Uses, Interactions, Mechanism of Action

Mercaptopurine is one of a large series of purine analogues which interfere with nucleic acid biosynthesis and has been found active against human leukemias. It ...

10.

bloodcancerunited.org

bloodcancerunited.org/blood-cancer-care/cancer-drug-listing/mercaptopurine

Mercaptopurine

Mercaptopurine is FDA approved to treat people who have acute lymphoblastic leukemia as part of a combination regimen. Side effects needing medical attention.