#1 Clinical Trials Search in Europe

Revumenib

Revumenib, also known as SNDX-5613, is an investigational drug being studied in clinical trials for the treatment of various types of acute leukemias. This article explores the ongoing research on Revumenib, focusing on its potential benefits for patients with relapsed or refractory leukemias, particularly those with specific genetic alterations.

Table of Contents

What is Revumenib?

Revumenib, also known by its scientific name SNDX-5613, is a new investigational drug being studied for the treatment of various types of acute leukemias[1]. It belongs to a class of drugs called menin inhibitors, which work in a unique way to target specific genetic changes found in some leukemias[2].

How Does Revumenib Work?

Revumenib works by blocking a protein called menin in the cell nucleus. Some types of leukemia cells depend on menin to survive and grow. By inhibiting menin, Revumenib can potentially stop the production of these leukemia cells[3]. This drug is particularly effective against leukemias with specific genetic changes, such as mutations in the NPM1 gene or rearrangements in the KMT2A (also known as MLL) gene[4].

What Conditions Does Revumenib Treat?

Revumenib is being studied for the treatment of several types of acute leukemias, including:

  • Acute Myeloid Leukemia (AML): A type of cancer that affects the blood and bone marrow, causing rapid growth of abnormal white blood cells[1]
  • Acute Lymphoblastic Leukemia (ALL): A cancer of the lymphoid line of blood cells, characterized by the development of large numbers of immature lymphocytes[5]
  • Mixed Phenotype Acute Leukemia (MPAL): A rare type of leukemia that shows features of both AML and ALL[6]
  • Acute Leukemia of Ambiguous Lineage: A type of leukemia that doesn’t fit clearly into other categories[7]

Revumenib is being investigated for both newly diagnosed cases and for patients whose leukemia has relapsed (come back) or is refractory (not responding) to other treatments[8].

Clinical Trials and Research

Revumenib is currently being studied in several clinical trials to determine its safety and effectiveness. These trials are investigating Revumenib in various scenarios:

  • As a single agent for relapsed or refractory leukemias[5]
  • In combination with standard chemotherapy drugs for newly diagnosed leukemias[9]
  • In combination with other targeted therapies like venetoclax and azacitidine[7]
  • For patients with specific genetic mutations, such as NPM1 or KMT2A rearrangements[3]

Researchers are also exploring its potential use in solid tumors, such as colorectal cancer[10].

Administration and Dosage

Revumenib is typically administered orally, either as capsules or a liquid solution. In some cases, it can be given through a feeding tube. The dosage and frequency may vary depending on the specific clinical trial and the patient’s condition. In most studies, Revumenib is given twice daily[1][2].

Potential Side Effects

As Revumenib is still in clinical trials, the full range of potential side effects is not yet known. Researchers are closely monitoring patients for any adverse events. Common side effects observed in cancer treatments may include fatigue, nausea, and changes in blood cell counts. The clinical trials are designed to assess the safety profile of Revumenib and determine the most appropriate dosage to minimize side effects while maximizing effectiveness[6].

Future Prospects

Revumenib shows promise as a targeted therapy for specific types of acute leukemias. If successful in clinical trials, it could provide a new treatment option for patients with limited alternatives, especially those with relapsed or refractory disease. The drug’s ability to target specific genetic mutations could lead to more personalized treatment approaches in leukemia care[3][4].

As research continues, more information will become available about Revumenib’s effectiveness, safety, and potential applications in cancer treatment. Patients interested in learning more about Revumenib or participating in clinical trials should consult with their healthcare providers to discuss if this investigational treatment might be appropriate for their specific situation.

Aspect Details
Drug Name Revumenib (SNDX-5613)
Drug Type Menin inhibitor
Target Conditions Acute leukemias (AML, ALL, MPAL) with specific genetic alterations
Administration Oral, typically twice daily
Trial Phases Phase 1 and 2 studies ongoing
Combination Therapies Being studied alone and in combination with chemotherapy
Key Outcomes Measured Safety, tolerability, pharmacokinetics, efficacy (response rates, survival)
Patient Population Adults and some pediatric patients with relapsed/refractory leukemias

FAQ

  • What is Revumenib and how does it work? Revumenib is an investigational drug that works as a menin inhibitor. It blocks a specific molecule called menin in the cell nucleus, which is important for some types of leukemia cells, especially those with mutations in genes like NPM1 or KMT2A. By disrupting the production of these leukemia cells, Revumenib may help control the disease.
  • What types of leukemia is Revumenib being studied for? Revumenib is being studied for various types of acute leukemias, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), mixed phenotype acute leukemia (MPAL), and other relapsed or refractory leukemias. It is particularly focused on leukemias with specific genetic alterations such as KMT2A rearrangements, NPM1 mutations, or NUP98 rearrangements.
  • How is Revumenib administered in clinical trials? In most clinical trials, Revumenib is administered orally, typically twice daily. The exact dosing schedule may vary depending on the specific trial and whether it is being given alone or in combination with other treatments.
  • What are some potential side effects of Revumenib? As with any investigational drug, the full range of side effects is still being studied. Clinical trials are designed to monitor for adverse events and determine the safety profile of Revumenib. Common side effects observed in cancer treatments may include fatigue, nausea, and changes in blood cell counts, but specific side effects for Revumenib will be better understood as more data becomes available from ongoing trials.
  • How can patients participate in clinical trials involving Revumenib? Patients interested in participating in clinical trials involving Revumenib should discuss this option with their healthcare provider. Eligibility criteria vary for each trial, but generally include factors such as the type and stage of leukemia, previous treatments, and overall health status. Information about ongoing trials can be found on clinical trial registry websites or through cancer research centers.

Ongoing Clinical Trials on Revumenib

  • Study of Revumenib and Chemotherapy for Patients with Newly Diagnosed Acute Myeloid Leukemia with NPM1 Gene Mutation

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +7

  • Study on Revumenib, Azacitidine, and Venetoclax for Adults with Newly Diagnosed Acute Myeloid Leukemia Not Eligible for Intensive Chemotherapy

    Recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium Denmark Estonia Finland France +8

  • Study of Revumenib, Cytarabine, and Fludarabine in Children with Relapsed or Refractory Acute Myeloid Leukemia

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Austria Czechia Denmark Germany Italy The Netherlands +2

  • Study on the Safety and Tolerability of SNDX-5613 for Patients with Relapsed or Refractory Acute Leukemias

    Not recruiting

    1 1
    Investigated drugs:
    France Germany Italy Lithuania The Netherlands Spain

Glossary

  • Acute Leukemia: A fast-growing cancer of the blood and bone marrow that affects the production of normal blood cells. It can be classified as acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) depending on the type of blood cells affected.
  • Relapsed/Refractory Leukemia: Leukemia that has either returned after a period of improvement (relapsed) or has not responded to initial treatment (refractory).
  • KMT2A Rearrangement: A genetic alteration involving the KMT2A gene (also known as MLL gene) that is associated with some types of acute leukemia.
  • NPM1 Mutation: A genetic change in the nucleophosmin 1 (NPM1) gene that is commonly found in some cases of acute myeloid leukemia.
  • Menin Inhibitor: A type of drug that blocks the action of menin, a protein involved in the development of some leukemias.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Complete Remission (CR): A state where there is no evidence of disease and blood cell counts have returned to normal levels after treatment.
  • Measurable Residual Disease (MRD): The small number of cancer cells that may remain in the body during or after treatment, even when a person is in remission.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.

References

  1. https://clinicaltrials.gov/study/NCT05406817
  2. https://clinicaltrials.gov/study/NCT06229912
  3. https://clinicaltrials.eu/trial/study-on-revumenib-azacitidine-and-venetoclax-for-adults-with-newly-diagnosed-acute-myeloid-leukemia-not-eligible-for-intensive-chemotherapy/
  4. https://clinicaltrials.gov/study/NCT06284486
  5. https://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-sndx-5613-for-patients-with-relapsed-or-refractory-acute-leukemias/
  6. https://clinicaltrials.gov/study/NCT05326516
  7. https://clinicaltrials.gov/study/NCT06177067
  8. https://clinicaltrials.gov/study/NCT05918913
  9. https://clinicaltrials.gov/study/NCT06313437
  10. https://clinicaltrials.gov/study/NCT05731947