Medication Adherence Programs for ALL

Recruiting at 24 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Oncology Group

Must be taking: 6MP

Disqualifiers: Other trial participation, others

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

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

Compensation: Varies

Number of Visits: 4

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial tests different programs to help patients with acute lymphoblastic leukemia (ALL) remember to take their medications during maintenance therapy at home. One problem with ALL maintenance treatment is remembering to take medicines at home like patients are supposed to. In maintenance, a medicine called 6-mercaptopurine or "6MP" is taken by mouth every day at home. In this study, 6MP prescriptions are filled into a special medication bottle called MEMS® which is fitted with a special cap called TrackCap™ that electronically records when the medication bottle is opened. Researchers are trying a new program to help patients be better at taking their 6MP like they're supposed to. This new program may help patients to remember to take their 6MP medication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it focuses on helping you remember to take a specific medication called 6MP during maintenance therapy.

What data supports the effectiveness of the drug Mercaptopurine (6-MP) for treating acute lymphoblastic leukemia (ALL)?

Research shows that taking Mercaptopurine (6-MP) as prescribed is crucial for preventing relapse in children with acute lymphoblastic leukemia (ALL). Studies highlight that when children do not take the drug regularly, their risk of the cancer returning increases. ^{1 2 3 4 5}

Is 6-Mercaptopurine safe for humans?

The research articles focus on medication adherence to 6-Mercaptopurine in children with acute lymphoblastic leukemia (ALL) and do not provide specific safety data. However, 6-Mercaptopurine is commonly used in treatment, suggesting it is generally considered safe when used as prescribed. ^{1 2 3 4 5}

What makes the drug Mercaptopurine unique for treating acute lymphoblastic leukemia?

Mercaptopurine is unique because it is an oral chemotherapy drug specifically used for treating acute lymphoblastic leukemia (ALL) in children, and its effectiveness heavily relies on consistent adherence to the medication schedule. Unlike some other treatments, it can be supported by mobile health (mHealth) interventions to improve adherence and reduce the risk of relapse. ^{1 4 5 6 7}

Research Team

Smita Bhatia

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for young people aged 10-25 with acute lymphoblastic leukemia (ALL), who are about to start maintenance therapy and can take pills. They must be treated at a COG institution in the US, speak English or Spanish, not use a pillbox, have an adult to help them, and be willing to use a smart cap on their medicine bottle and get reminders on a smartphone.

Inclusion Criteria

I plan to take 6MP tablets during my cancer treatment's maintenance phase.

I am receiving treatment at a COG institution in the US.

I (and my parent or guardian, if applicable) can communicate in English or Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Maintenance Therapy

Participants begin using the MEMS® medication bottle with TrackCap™ and are monitored for adherence to 6MP medication

60 weeks

Regular clinic visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the main intervention

4 weeks

Treatment Details

Interventions

• Mercaptopurine

Trial Overview The study tests programs that remind patients to take their daily oral medication, 6-mercaptopurine (6MP), using MEMS® TrackCap™—a special cap that records when it's opened—to improve adherence during home treatment of ALL.

Participant Groups

Group I: Non-adherers arm II (U-iIP) Experimental Treatment 10 Interventions

See Detailed Description.

Group II: Non-adherers arm I (IP) Experimental Treatment 10 Interventions

See Detailed Description.

Group III: Adherers arm IV (pIP) Experimental Treatment 10 Interventions

See Detailed Description.

Group IV: Adherers arm III (EDU) Experimental Treatment 6 Interventions

Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of Maintenance cycle 3 and for the remaining duration of the study. Patients and their caregiver view the MIPE program that features video clips of ALL patients and their parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3. Additionally, patients undergo blood sample collection on the study.

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+

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]

In a study of 19 pediatric patients with acute lymphoblastic leukemia (ALL) receiving 6-mercaptopurine (6-MP), 26.3% were identified as non-adherent to their medication, primarily due to carelessness and forgetfulness.

The study emphasized the effectiveness of using a combination of objective measures (like drug metabolite concentrations) and subjective self-reports to assess adherence, suggesting that this dual approach provides a more accurate picture of medication compliance in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of an objective methodology to measure medication adherence to oral thiopurines in paediatric patients with acute lymphoblastic leukaemia--an exploratory study. Hawwa, AF., Millership, JS., Collier, PS., et al.[2022]

In a study of 327 children with acute lymphoblastic leukemia, adherence to the oral medication mercaptopurine (MP) significantly declined from 94.7% in the first month to 90.2% by the sixth month, with lower adherence rates observed in Hispanic children and those from single-mother households.

Lower adherence to MP was associated with a higher risk of relapse, particularly among Hispanic patients, indicating that improving medication adherence could be crucial for reducing relapse rates in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonadherence to oral mercaptopurine and risk of relapse in Hispanic and non-Hispanic white children with acute lymphoblastic leukemia: a report from the children's oncology group. Bhatia, S., Landier, W., Shangguan, M., et al.[2023]

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]

In a study involving 49 parents and 15 pediatric patients with acute lymphoblastic leukemia (ALL), 43% of parents and a striking 73% of patients reported suboptimal adherence to the oral chemotherapy drug 6-mercaptopurine (6-MP).

Both parents and patients identified multiple barriers to adherence, particularly in physical and social opportunities, indicating that interventions to improve adherence must address these diverse challenges to help prevent relapse and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the COM-B model to patient-reported barriers to medication adherence in pediatric acute lymphoblastic leukemia. 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]

In a study of 139 pediatric cancer patients over 15 months, researchers found that 40.8% of participants had low levels of 6-mercaptopurine metabolites, indicating nonadherence or suboptimal therapy, while 59.2% showed adequate adherence.

The study uniquely combined pharmacological measures (metabolite levels) with behavioral measures (electronic monitoring) to assess medication adherence, highlighting the importance of using multiple methods to identify patients who may need additional support in their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Medication Adherence in Pediatric Cancer: An Approach to Validation. Rohan, JM., Fukuda, T., Alderfer, MA., et al.[2020]

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. Germany pubmed.ncbi.nlm.nih.gov

The development of an objective methodology to measure medication adherence to oral thiopurines in paediatric patients with acute lymphoblastic leukaemia--an exploratory study. [2022]

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

Nonadherence to oral mercaptopurine and risk of relapse in Hispanic and non-Hispanic white children with acute lymphoblastic leukemia: a report from the children's oncology group. [2023]

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

Applying the COM-B model to patient-reported barriers to medication adherence in pediatric acute lymphoblastic leukemia. [2021]

6. 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]

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

Measuring Medication Adherence in Pediatric Cancer: An Approach to Validation. [2020]