Mercaptopurine Compliance for Leukemia

Recruiting at 108 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

570 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia that has had a decrease in or disappearance of signs and symptoms of cancer (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.

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.

What data supports the effectiveness of the drug Mercaptopurine for leukemia?

Research shows that using mobile health technology can help children with leukemia remember to take Mercaptopurine, which is important because not taking it properly can lead to the cancer coming back. Also, adjusting the dose of Mercaptopurine based on individual needs during treatment can improve outcomes for children with leukemia. ^{1 2 3 4 5}

Is mercaptopurine safe for humans?

Mercaptopurine (also known as 6-MP) is used in treating acute lymphoblastic leukemia (ALL) but can cause side effects like skin issues, liver problems, and low blood sugar. Some children may need to stop or reduce their dose due to these side effects. ^{1 2 6 7 8}

What makes the drug mercaptopurine unique for treating leukemia?

Mercaptopurine is unique because it is an oral chemotherapy drug specifically used for maintenance therapy in children with acute lymphoblastic leukemia (ALL). Its effectiveness can vary greatly among patients, and it requires careful monitoring due to potential side effects and variability in how the body processes the drug. ^{2 3 6 9 10}

Research Team

Smita Bhatia

Principal Investigator

Children's Oncology Group

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Canada 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Electronic measurement of compliance with mercaptopurine in pediatric patients with acute lymphoblastic leukemia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Individual prediction of nonadherence to oral mercaptopurine in children with acute lymphoblastic leukemia: Results from COG AALL03N1. [2022]

4. United States 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Individualized 6-mercaptopurine increments in consolidation treatment of childhood acute lymphoblastic leukemia: A NOPHO randomized controlled trial. [2018]

6. China pubmed.ncbi.nlm.nih.gov

[Tolerability of 6-mercaptopurine in children with acute lymphoblastic leukemia]. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Skin Toxicity Due to Mercaptopurine in Maintenance Therapy Among Children With Acute Lymphoblastic Leukemia. [2023]

8. China pubmed.ncbi.nlm.nih.gov

[Correlations between 6-mercaptopurine treatment-related adverse reactions in children with acute lymphoblastic leukemia and polymorphisms of thiopurine methyltransferase gene]. [2017]

9. Iran pubmed.ncbi.nlm.nih.gov

Simultaneous Determination of 6-Mercaptopurine and its Oxidative Metabolites in Synthetic Solutions and Human Plasma using Spectrophotometric Multivariate Calibration Methods. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic determinants of 6-mercaptopurine myelotoxicity and therapeutic failure in children with acute lymphoblastic leukemia. [2019]