Medication Adherence Programs for ALL

Not currently recruiting at 26 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests programs designed to help patients with acute lymphoblastic leukemia (ALL) remember to take their medication during maintenance therapy. It focuses on using a special medication bottle with an electronic cap that records when opened, aiming to improve adherence to the daily oral medication, 6-mercaptopurine (6MP). Participants either try these new reminder programs or receive educational support. For those with ALL who are about to start maintenance therapy and are receiving treatment at a Children's Oncology Group institution, this trial might be suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative strategies for improving medication adherence.

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 prior data suggests that this program is safe for patients with acute lymphoblastic leukemia?

Research has shown that mercaptopurine (6MP) is a proven treatment for acute lymphoblastic leukemia (ALL) in both children and adults. The FDA has approved it, indicating general safety when used correctly. Studies have found it effective for children, which is important for families considering this option.

However, like all medications, mercaptopurine can cause side effects. Some patients might experience low white blood cell counts or liver issues. Monitoring these potential side effects through regular blood tests is important while taking the medication.

Overall, mercaptopurine is considered safe, especially for treating ALL. Discussing any concerns with a healthcare provider is always best, as they can offer advice based on specific health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Medication Adherence Programs for Acute Lymphoblastic Leukemia (ALL) because they aim to improve how patients stick to their treatment plans, which is crucial for the effectiveness of mercaptopurine, a standard chemotherapy drug for ALL. Unlike traditional treatments that primarily focus on the drug's efficacy, these programs emphasize patient support through educational tools and innovative tracking methods like the MEMS® TrackCap™. By addressing adherence directly, these programs could lead to better treatment outcomes and a deeper understanding of how patients manage long-term medication regimens.

What evidence suggests that this trial's programs could be effective for improving medication adherence in ALL patients?

This trial will evaluate different medication adherence programs for children with acute lymphoblastic leukemia (ALL) to improve adherence to mercaptopurine (6-MP). Studies have shown that taking the daily dose of mercaptopurine is crucial for children with ALL. Taking less than 90% of their doses increases the risk of cancer returning. Specifically, taking less than 95% of the prescribed doses is directly linked to more relapses. Research also indicates that not taking the medication as prescribed is common, with rates ranging from 2% to 54% among children. Therefore, maintaining the 6-MP schedule can be a key factor in controlling the cancer. ^{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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11976682/

Adherence to 6‐Mercaptopurine (6‐MP) and Habit ... Low 6-mercaptopurine (6-MP) adherence (< 95%) is associated with increased relapse in pediatric acute lymphoblastic leukemia (ALL).

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.10030

Adherence to mercaptopurine (6-MP) and habit strength in ... Background: Rates of adherence to mercaptopurine (6-MP) below 90% have been associated with increased relapse in pediatric patients with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01503632

Study Details | NCT01503632 | Assessing Compliance ... This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/27527530221122685

A Survey Study From the Dana-Farber Cancer Institute ... During therapy for acute lymphoblastic leukemia (ALL), poor adherence to 6-mercaptopurine (6MP) increases relapse risk. Clinically significant nonadherence is ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0183119

Adherence to 6-Mercaptopurine in children and adolescents ... Studies on children with Acute Lymphoblastic Leukemia (ALL) reported non-adherence in 2–54% of cases. The primary objective of this study was to assess rates of ...

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 published ...

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. go.drugbank.com go.drugbank.com/drugs/DB01033

Mercaptopurine: Uses, Interactions, Mechanism of Action Mercaptopurine is an antineoplastic agent used to treat acute lymphocytic leukemia. Brand Names. Purixan, Xaluprine. Generic Name: Mercaptopurine; DrugBank ...

10. drugs.com drugs.com/pro/mercaptopurine.html

Mercaptopurine: Package Insert / Prescribing Info / MOA Safety and effectiveness of MERCAPTOPURINE has been established in pediatric patients. Use of MERCAPTOPURINE in pediatrics is supported by ...