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Anagrelide Hydrochloride Monohydrate

This article discusses the use of Anagrelide Hydrochloride Monohydrate in clinical trials, particularly focusing on its potential role in treating Essential Thrombocythemia. Essential Thrombocythemia is a rare blood disorder characterized by an overproduction of platelets. The clinical trial aims to evaluate the safety and efficacy of Anagrelide Hydrochloride Monohydrate as part of a comparative study with other treatments for patients who have not responded well to or cannot tolerate standard therapies.

Table of Contents

What is ANAGRELIDE HYDROCHLORIDE MONOHYDRATE?

ANAGRELIDE HYDROCHLORIDE MONOHYDRATE is a medication used in the treatment of certain blood disorders. It’s classified as a chemical substance and is available in capsule form for oral administration.[1]

What Medical Condition Does It Treat?

This medication is primarily used to treat Essential Thrombocythemia (ET). ET is a rare blood disorder characterized by an overproduction of platelets in the bone marrow. Platelets are blood cells that help with blood clotting. In ET, the excessive number of platelets can lead to serious complications such as blood clots or bleeding problems.[1]

How Does It Work?

ANAGRELIDE HYDROCHLORIDE MONOHYDRATE works by reducing the production of platelets in the bone marrow. This helps to bring the platelet count back to a normal range, reducing the risk of complications associated with ET.[1]

How Is It Administered?

This medication is taken orally in the form of capsules. It’s important to follow your doctor’s instructions carefully when taking this medication.[1]

What Is the Dosage?

The maximum daily dose of ANAGRELIDE HYDROCHLORIDE MONOHYDRATE is 10 mg. The total maximum dose over the course of treatment is 3650 mg. The maximum treatment period is typically 36 months. However, the exact dosage and duration of treatment will be determined by your healthcare provider based on your individual needs and response to the medication.[1]

Current Clinical Trial Information

A Phase 3 clinical trial is currently being conducted to evaluate a new medication called Bomedemstat for patients with Essential Thrombocythemia who have not responded well to or cannot tolerate a medication called hydroxyurea. This trial is comparing Bomedemstat to the best available therapy, which may include ANAGRELIDE HYDROCHLORIDE MONOHYDRATE.[1]

The main goal of this study is to compare how well Bomedemstat works compared to the best available therapy in achieving a durable clinicohematologic response (DCHR). This means they’re looking at how well the treatments control the disease over time.[1]

The study is also looking at other important factors, including:

  • Changes in fatigue levels
  • Changes in overall symptoms
  • How long the treatment response lasts
  • The occurrence of blood clots or major bleeding events
  • How the disease progresses
  • The safety and tolerability of the treatments[1]

Who Is Eligible for the Treatment?

While the specific eligibility for ANAGRELIDE HYDROCHLORIDE MONOHYDRATE may vary, the current clinical trial provides some insight into who might be considered for this type of treatment. Eligible patients typically:

  • Have a diagnosis of Essential Thrombocythemia according to the World Health Organization’s 2016 diagnostic criteria for myeloproliferative neoplasms
  • Have a bone marrow fibrosis score of Grade 0 or Grade 1
  • Have not responded well to or cannot tolerate hydroxyurea
  • Have a platelet count higher than 450 x 10^9/L
  • Have an absolute neutrophil count (ANC) ≥0.75 x 10^9/L
  • May have received up to 3 prior lines of therapy including hydroxyurea[1]

Who Should Not Take This Medication?

Based on the exclusion criteria for the clinical trial, certain factors might make a person unsuitable for this type of treatment. These may include:

  • Known allergies or sensitivities to similar drugs
  • Gastrointestinal conditions that might interfere with drug absorption
  • Increased risk of bleeding
  • Recent history of certain types of cancer
  • HIV infection with a history of specific complications[1]

It’s important to note that these are general guidelines. Your healthcare provider will consider your individual medical history and current health status when determining if ANAGRELIDE HYDROCHLORIDE MONOHYDRATE is appropriate for you.

Aspect Details
Drug Name Anagrelide Hydrochloride Monohydrate
Administration Oral capsule
Maximum Daily Dose 10 mg
Maximum Total Dose 3650 mg
Treatment Duration Up to 36 months
Target Condition Essential Thrombocythemia
Patient Eligibility Inadequate response to or intolerance of hydroxyurea
Primary Endpoint Durable Clinicohematologic Response (DCHR) Rate
Key Secondary Endpoints Changes in fatigue and symptom scores, thrombotic events, hemorrhagic events, disease progression
Safety Evaluation Adverse events, treatment discontinuation due to adverse events

FAQ

  • What is Essential Thrombocythemia? Essential Thrombocythemia is a rare blood disorder where the body produces too many platelets. Platelets are blood cells that help with clotting. This condition can increase the risk of blood clots and bleeding problems.
  • What is the purpose of using Anagrelide Hydrochloride Monohydrate in this clinical trial? Anagrelide Hydrochloride Monohydrate is being studied as a potential treatment option for patients with Essential Thrombocythemia who have not responded well to or cannot tolerate the standard treatment, hydroxyurea.
  • How is Anagrelide Hydrochloride Monohydrate administered in the trial? In this clinical trial, Anagrelide Hydrochloride Monohydrate is administered orally in capsule form. The maximum daily dose is 10 mg, and the maximum total dose over the treatment period is 3650 mg.
  • What are the main objectives of the clinical trial? The main objective is to compare the effectiveness of a new drug called bomedemstat to the best available therapy, which includes Anagrelide Hydrochloride Monohydrate. The trial aims to evaluate the safety, efficacy, and impact on quality of life for patients with Essential Thrombocythemia.
  • Who is eligible to participate in this clinical trial? Eligible participants are those diagnosed with Essential Thrombocythemia who have not responded adequately to or cannot tolerate hydroxyurea. They must have a platelet count above 450,000 per microliter and meet other specific health criteria outlined in the trial protocol.

Ongoing Clinical Trials on Anagrelide Hydrochloride Monohydrate

  • Study on Bomedemstat for Patients with Essential Thrombocythemia Not Responding to or Intolerant of Hydroxyurea, Comparing with a Drug Combination

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France Germany Hungary Italy The Netherlands +4

Glossary

  • Essential Thrombocythemia (ET): A rare blood disorder characterized by an overproduction of platelets in the bone marrow, which can increase the risk of blood clots and bleeding problems.
  • Hydroxyurea: A standard treatment for Essential Thrombocythemia that helps reduce platelet counts. Some patients may not respond well to this treatment or may experience intolerable side effects.
  • Platelet count: The number of platelets in a given volume of blood. In this trial, participants must have a platelet count above 450,000 per microliter.
  • Cytoreductive therapy: Treatment that reduces the number of blood cells produced by the bone marrow, often used in managing blood disorders like Essential Thrombocythemia.
  • Bone marrow fibrosis: A condition where the bone marrow develops scar tissue, potentially affecting blood cell production. In this trial, participants must have a low grade (0 or 1) of bone marrow fibrosis.
  • Clinicohematologic Response: A measure of how well a treatment is working, considering both clinical symptoms and blood test results.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • Event Free Survival (EFS): The length of time after treatment during which a patient survives without any complications or events related to their disease.
  • Myelofibrosis Symptom Assessment Form (MFSAF): A questionnaire used to assess symptoms experienced by patients with myeloproliferative disorders, including Essential Thrombocythemia.
  • Best Available Therapy (BAT): The most effective known treatment for a condition, which may vary depending on individual patient factors and available options.

References

  1. http://clinicaltrials.eu/trial/study-on-bomedemstat-for-patients-with-essential-thrombocythemia-not-responding-to-or-intolerant-of-hydroxyurea-comparing-with-a-drug-combination/