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Mercaptopurine Monohydrate

Mercaptopurine Monohydrate, a medication used in the treatment of various conditions, is currently being studied in clinical trials for its potential in treating Langerhans Cell Histiocytosis (LCH) in children and adolescents. This article explores the use of Mercaptopurine Monohydrate in the LCH-IV International Collaborative Treatment Protocol, which aims to improve outcomes for young patients with this rare disease.

Table of Contents

What is Mercaptopurine?

Mercaptopurine Monohydrate is a medication that belongs to a class of drugs known as antimetabolites[1]. It is marketed under the brand name “Mercaptopurine Silver Pharma 50 mg tablets” and is classified as a cytostatic drug, which means it helps to stop or slow down the growth of cells[1]. This medication is primarily used in the treatment of certain types of cancer and other conditions where controlling cell growth is important.

Medical Uses

While the primary focus of the clinical trial data is on Langerhans Cell Histiocytosis (LCH), mercaptopurine is known to be used in various medical conditions. In this context, it’s being studied as part of a treatment protocol for children and adolescents with LCH[1]. Langerhans Cell Histiocytosis is a rare disorder that can affect various parts of the body, including the skin, bones, and internal organs.

Mercaptopurine is classified under the ATC code L01BB02, which indicates its use as an antineoplastic agent[1]. Antineoplastic agents are medications used to treat cancer. This classification suggests that mercaptopurine is primarily used in the treatment of various types of cancers, particularly those affecting the blood and immune system.

Dosage and Administration

According to the clinical trial data, mercaptopurine is administered in the following way:

  • The medication comes in the form of tablets[1].
  • It is taken orally[1].
  • The maximum daily dose is reported as 50 mg/m² (milligrams per square meter of body surface area)[1]. This dosing method allows for more precise dosing based on the patient’s body size.
  • The maximum total dose amount mentioned is 33,950 mg/m²[1].
  • The maximum treatment period is reported as 96 weeks (approximately 22 months)[1].

It’s important to note that these dosages are specific to the clinical trial and may not reflect the typical dosing for all patients or conditions. Always follow your doctor’s instructions regarding dosage and administration.

Clinical Trial Information

The clinical trial data provides information about a study called “LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis”[1]. While mercaptopurine is mentioned as part of this study, it’s important to understand that this trial is investigating a combination of treatments, not just mercaptopurine alone.

Key points about the trial include:

  • It’s a Phase II and III integrated clinical trial, which means it’s testing both the effectiveness and safety of the treatment protocol[1].
  • The main objectives include reducing mortality in multi-system LCH and investigating ways to reduce disease reactivation and late sequelae (long-term effects of the disease)[1].
  • The trial is studying various aspects of LCH treatment, including different durations of therapy and combinations of medications[1].

Important Considerations

When taking mercaptopurine, there are several important factors to keep in mind:

  • Medical Supervision: This medication should only be taken under close medical supervision due to its potent effects and potential side effects[1].
  • Regular Monitoring: Your doctor will likely require regular blood tests to monitor your response to the medication and check for potential side effects[1].
  • Potential Side Effects: As a cytostatic drug, mercaptopurine can affect rapidly dividing cells in the body. This can lead to side effects such as decreased blood cell counts, increased risk of infections, and gastrointestinal issues[1].
  • Interactions: Mercaptopurine may interact with other medications. Always inform your healthcare provider about all medications you’re taking[1].
  • Long-term Treatment: The clinical trial data suggests that treatment with mercaptopurine can last for an extended period (up to 96 weeks). Your doctor will determine the appropriate duration of treatment based on your specific condition and response to the medication[1].

Remember, while this information provides a general overview of mercaptopurine, your healthcare provider is the best source of information about how this medication relates to your specific medical condition and treatment plan.

Aspect Details
Trial Name LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis
Condition Studied Langerhans Cell Histiocytosis (LCH)
Drug Studied Mercaptopurine Monohydrate (among others)
Drug Form Tablets, 50 mg
Maximum Daily Dose 50 mg/m²
Maximum Total Dose 33,950 mg/m²
Treatment Duration Up to 96 weeks
Administration Route Oral
Main Objectives Reduce mortality, investigate prolonged/intensified continuation therapy, reduce reactivations and late sequelae
Primary Endpoints Reactivation-free survival, overall survival, disease-free survival, neurodegenerative CNS-LCH progression

FAQ

  • What is Langerhans Cell Histiocytosis (LCH)? Langerhans Cell Histiocytosis (LCH) is a rare disorder classified under neoplasms (abnormal tissue growths). It affects children and adolescents, causing an overproduction of certain immune cells that can accumulate in various parts of the body, leading to different symptoms and complications.
  • How is Mercaptopurine Monohydrate used in the LCH-IV trial? Mercaptopurine Monohydrate is used as part of the continuation therapy in the LCH-IV trial. It is administered orally in tablet form, with a maximum daily dose of 50 mg/m² (milligrams per square meter of body surface area). The treatment can last up to 96 weeks.
  • What are the main objectives of the LCH-IV trial? The main objectives of the LCH-IV trial include reducing mortality in multi-system LCH, investigating prolonged or intensified continuation therapy to reduce reactivations and late effects, and studying the effectiveness of different treatment approaches for various LCH presentations.
  • Who is eligible to participate in the LCH-IV trial? Eligible participants are children and adolescents with a histologically verified diagnosis of LCH who have not received prior systemic therapy. They must meet the inclusion criteria for their respective treatment stratum and have signed informed consent.
  • What are the primary endpoints of the LCH-IV trial? The primary endpoints of the trial include reactivation-free survival, overall and disease-free survival, studying the course of neurodegenerative CNS-LCH, response of isolated tumorous CNS lesions to treatment, and the rate and spectrum of permanent consequences of the disease and its treatment.

Ongoing Clinical Trials on Mercaptopurine Monohydrate

  • Study on Langerhans Cell Histiocytosis Treatment in Children and Adolescents Using Cladribine, Prednisolone, and Cytarabine

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Greece Ireland +6

Glossary

  • Langerhans Cell Histiocytosis (LCH): A rare disorder where certain immune cells (histiocytes) build up in various tissues and organs, causing damage. It primarily affects children and can range from mild to severe.
  • Mercaptopurine Monohydrate: A medication used in the treatment of various conditions, including certain types of cancer and autoimmune disorders. In this trial, it is being studied for its potential in treating LCH.
  • Multi-system LCH (ms-LCH): A form of LCH where multiple organ systems are affected by the disease, often including high-risk organs such as the liver, spleen, or bone marrow.
  • Single-system LCH (ss-LCH): A form of LCH where only one organ system is affected by the disease.
  • CNS-Risk lesion: Bone lesions in specific areas of the skull that are associated with an increased risk of central nervous system (brain and spinal cord) involvement in LCH.
  • Reactivation: The return of disease activity after a period of improvement or remission.
  • Permanent consequences: Long-lasting or irreversible effects of the disease or its treatment on a patient's health or quality of life.
  • Neurodegenerative CNS-LCH: A complication of LCH where the central nervous system (brain and spinal cord) is progressively damaged over time.
  • Continuation therapy: Extended treatment given after the initial, more intensive phase of therapy to maintain remission and prevent disease recurrence.

References

  1. http://clinicaltrials.eu/trial/study-on-langerhans-cell-histiocytosis-treatment-in-children-and-adolescents-using-cladribine-prednisolone-and-cytarabine/