← Back to Search

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

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

Patient and parent/caregiver must speak English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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

Select...

I have completed 24 weeks of ongoing cancer treatment and will continue for at least another 24 weeks.

Select...

I, and my caregiver if applicable, can communicate in English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mercaptopurine

Secondary study objectives

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

79%

Neutrophil count decreased

66%

Febrile neutropenia

64%

Infections and infestations - Other, specify

47%

Alanine aminotransferase increased

38%

White blood cell decreased

35%

Platelet count decreased

32%

Anemia

25%

Aspartate aminotransferase increased

23%

Hypokalemia

15%

Mucositis oral

11%

Catheter related infection

11%

Anaphylaxis

Dehydration

Hyperglycemia

Lung infection

Fever

Hyponatremia

Diarrhea

Upper respiratory infection

Vomiting

Lymphocyte count decreased

Anorexia

Otitis media

Enterocolitis infectious

Fibrinogen decreased

Hypertension

Hypoglycemia

Abdominal pain

Peripheral sensory neuropathy

Skin infection

Oral pain

GGT increased

Hypoxia

Weight loss

Sinusitis

Constipation

Urinary tract infection

Activated partial thromboplastin time prolonged

Blood bilirubin increased

Peripheral motor neuropathy

Hypoalbuminemia

Lipase increased

Hypophosphatemia

Hyperkalemia

Pain in extremity

Headache

Nausea

Bronchial infection

Blood and lymphatic system disorders - Other, specify

Seizure

Pneumonitis

Serum amylase increased

Hypocalcemia

Pancreatitis

Back pain

Wound infection

Nervous system disorders - Other, specify

Pleural effusion

Fatigue

Agitation

Syncope

Gait disturbance

Epistaxis

Ileus

Personality change

Pain

Bronchospasm

Abdominal distension

Abdominal infection

Alkaline phosphatase increased

Anorectal infection

Bone infection

Dysphasia

Flu like symptoms

Gastritis

Hypotension

INR increased

Insomnia

Muscle weakness lower limb

Myalgia

Otitis externa

Sepsis

Typhlitis

Vascular disorders - Other, specify

Cough

Gum infection

Hypermagnesemia

Investigations - Other, specify

Mucosal infection

Portal hypertension

Thromboembolic event

Rectal mucositis

Respiratory, thoracic and mediastinal disorders - Other, specify

100%

80%

60%

40%

20%

Study treatment Arm

Prednisone and High Dose Methotrexate < 10 Yrs Old

Prednisone and High Dose Methotrexate (Non Randomly Assigned)

Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old

Dexamethasone, High Dose Methotrexate (IM) < 10 Years

Prednisone, Capezzi Methotrexate >= 10 Years

Prednisone, Capizzi Methotrexate <10 Years

Dexamethasone and Capizzi Methotrexate Patients < 10 Years

Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)

Prednisone and High Dose Methotrexate >=10 Years

Dexamethasone, High Dose Methotrexate (IM) >= 10 Years

Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)

Prednisone, Capezzi Methotrexate (Down's Syndrome)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~12550