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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

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

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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

72%

Neutrophil count decreased

57%

Infections and infestations - Other, specify

54%

Febrile neutropenia

47%

Alanine aminotransferase increased

39%

White blood cell decreased

39%

Platelet count decreased

32%

Hyperglycemia

27%

Anemia

24%

Aspartate aminotransferase increased

22%

Mucositis oral

19%

Hypokalemia

18%

Blood bilirubin increased

18%

Hyponatremia

16%

Anorexia

15%

Abdominal pain

15%

Vomiting

15%

Lipase increased

14%

Anaphylaxis

13%

Dehydration

13%

Headache

13%

Peripheral motor neuropathy

10%

Nausea

10%

Hypocalcemia

Hypoalbuminemia

Diarrhea

Hypoxia

Lung infection

Peripheral sensory neuropathy

Fibrinogen decreased

Avascular necrosis

Back pain

Serum amylase increased

Weight loss

Enterocolitis infectious

Depression

Fever

Hypotension

Pancreatitis

Hypophosphatemia

Pain in extremity

Arthralgia

Epistaxis

Lymphocyte count decreased

Upper respiratory infection

Hyperkalemia

Skin infection

Acute kidney injury

GGT increased

Pain

Dyspnea

Hypertension

Oral pain

Activated partial thromboplastin time prolonged

Bone pain

Typhlitis

Hypertriglyceridemia

Seizure

Urinary tract infection

Sinusitis

Glucose intolerance

Creatinine increased

Encephalopathy

Ileus

Pneumonitis

Syncope

Anxiety

Colitis

Fatigue

Rash maculo-papular

Thromboembolic event

Tumor lysis syndrome

Nervous system disorders - Other, specify

Esophagitis

Catheter related infection

Hypermagnesemia

Disseminated intravascular coagulation

Cough

Urticaria

Hemolysis

Dysphagia

Hypercalcemia

Hepatic failure

Acidosis

Confusion

Hypernatremia

Non-cardiac chest pain

Personality change

Vascular disorders - Other, specify

Anal mucositis

Dysphasia

Hypoglycemia

INR increased

Vascular access complication

Pleural effusion

Abdominal infection

Hematoma

Capillary leak syndrome

Intracranial hemorrhage

Hepatobiliary disorders - Other, specify

Gastrointestinal disorders - Other, specify

Dizziness

Allergic reaction

Hepatic infection

Psychosis

Skin ulceration

Pharyngitis

Ascites

Bone marrow hypocellular

Facial nerve disorder

Rectal pain

Hyperuricemia

Insomnia

Pancreas infection

Pharyngeal mucositis

Pneumothorax

Proteinuria

Muscle weakness lower limb

Anal pain

Cholecystitis

Enterocolitis

Hypomagnesemia

Immune system disorders - Other, specify

Investigations - Other, specify

Iron overload

Proctitis

Respiratory, thoracic and mediastinal disorders - Other, specify

Stomach pain

Musculoskeletal and connective tissue disorder - Other, specify

Weight gain

Blood and lymphatic system disorders - Other, specify

Adult respiratory distress syndrome

Myositis

Pharyngolaryngeal pain

Gastritis

100%

80%

60%

40%

20%

Study treatment Arm

Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old

Prednisone and High Dose Methotrexate < 10 Yrs Old

Prednisone and High Dose Methotrexate (Non Randomly Assigned)

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