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Study of valemetostat tosylate tablets in patients with relapsed or refractory B-cell lymphoma, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and Hodgkin lymphoma

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What is this study about?

This clinical study focuses on patients with B-cell lymphoma, a type of blood cancer that affects white blood cells. The study will evaluate a medication called valemetostat tosylate (also known as DS-3201b) in patients whose disease has returned or did not respond to previous treatments. The study includes different types of lymphomas such as diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Hodgkin lymphoma.

The medication being tested comes in the form of film-coated tablets that are taken by mouth. The purpose of this study is to determine how effective valemetostat tosylate is when used alone in treating these types of lymphoma. The treatment may continue for up to three years, depending on how well patients respond to the medication.

During the study, doctors will monitor how patients respond to the treatment by performing regular medical examinations and scans. They will specifically look at whether the cancer shrinks or disappears in response to the medication. The study will also track how long any positive responses to the treatment last and evaluate the safety of the medication.

1 Initial assessment

Your doctor will confirm your diagnosis of B-cell lymphoma or Hodgkin Lymphoma through tissue examination

Medical tests will be performed to check your liver, kidney, and bone marrow function

Your overall health status will be evaluated using the ECOG performance scale (a measure of daily activity ability)

2 Treatment initiation

You will receive valemetostat tosylate in the form of film-coated tablets

The medication will be taken by mouth

Your doctor will provide specific instructions about dosing schedule

3 Regular monitoring

Your response to treatment will be assessed using imaging scans

Regular blood tests will monitor your health status

Your doctor will track any changes in your condition

4 Response evaluation

Your doctor will measure how well the treatment is working using specialized imaging

The response will be classified as either complete response, partial response, or no response

The time until your lymphoma responds to treatment will be recorded

5 Follow-up period

After completing treatment, you will need to continue birth control measures for 3 months

Your doctor will continue monitoring your condition to track how long the response to treatment lasts

The study will continue until June 2025

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have confirmed B-cell lymphoma diagnosed by a doctor
  • Disease must be measurable with nodes larger than 1.5 cm or areas outside lymph nodes larger than 1.0 cm
  • Must have received previous standard treatments that did not work or disease came back after treatment
  • Must be able to perform daily activities with minimal assistance (ECOG performance status 0-2)
  • Must have adequate kidney function
  • Must have adequate blood cell counts:
    – Sufficient white blood cells
    – Sufficient platelets
    – Sufficient hemoglobin (oxygen-carrying protein)
  • Must have adequate liver function tests
  • Must have enough tissue sample available for laboratory testing
  • Must have enough DNA available for specific genetic testing
  • If history of hepatitis B or C, must have normal liver function and no active virus in blood
  • Women who can become pregnant must use effective birth control:
    – For 28 days before starting treatment
    – During the study
    – For 3 months after stopping treatment
  • Men with partners who can become pregnant must use effective birth control during the study and for 3 months after
  • Must be covered by social security system
  • Must understand and speak the country’s official language
  • Must provide written consent to participate

Who Cannot Join the Study?

  • Age below 18 years old
  • Previous participation in a clinical trial with valemetostat tosylate treatment
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Known allergies or hypersensitivity to the study medication or its components
  • Significant heart conditions, including:
    • Uncontrolled high blood pressure
    • Heart failure
    • Recent heart attack
    • Irregular heart rhythm requiring treatment
  • Active, uncontrolled infections requiring treatment
  • Other types of cancer requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Serious liver disease or abnormal liver function
  • Serious kidney disease or abnormal kidney function
  • Pregnancy or breastfeeding
  • Inability to swallow oral medications
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Grand Hopital De Charleroi Charleroi Belgium
CHR Verviers Verviers Belgium
Centre Hospitalier D Avignon Avignon France
Centre Hospitalier Universitaire d’Orléans Orléans France
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Bretagne Atlantique Vannes France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Centre Hospitalier Universitaire De Caen Normandie Caen France
L’Hopital Prive Du Confluent Nantes France
Iptlgouy Pftsantzxndgqko Cemfbg Cnksiy Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
30.06.2021
France France
Recruiting
30.06.2021

Trial locations

Valemetostat tosylate (also known as DS-3201b) is a medication being studied as a treatment for different types of blood cancers, specifically B-cell lymphomas. It works alone (as monotherapy) to treat patients whose cancer has either come back after previous treatment or hasn’t responded well to other treatments. This medication targets specific proteins in cancer cells that help control gene activity, potentially helping to stop cancer growth.

The medication is being tested in patients with various types of lymphoma, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Hodgkin lymphoma. It is taken as a single agent, meaning it is not combined with other cancer medications during this trial.

Investigated diseases:

Diffuse Large B-cell Lymphoma – A fast-growing cancer that develops in B-cells, a type of white blood cell that helps fight infections. The disease causes enlarged lymph nodes and can affect various parts of the body.

Primary Mediastinal B-cell Lymphoma – A type of lymphoma that develops in the chest area called the mediastinum. It typically occurs in young adults and causes breathing difficulties due to a growing mass in the chest.

Follicular Lymphoma – A slow-growing cancer that develops from B-lymphocytes. It typically appears as painless swellings in lymph nodes and can spread throughout the lymphatic system.

Mantle Cell Lymphoma – A cancer that starts in the outer edge (mantle zone) of lymph nodes. The disease usually affects lymph nodes and can spread to other organs.

Marginal Zone Lymphoma – A slow-growing lymphoma that develops in B-lymphocytes at the edges of lymphoid tissues. It can occur in lymph nodes, spleen, or other tissues.

Lymphoplasmacytic Lymphoma – A rare blood cancer where the body produces too many abnormal white blood cells. These cells can accumulate in bone marrow, lymph nodes, and other organs.

Hodgkin Lymphoma – A cancer that begins in lymphocytes within the lymphatic system. The disease is characterized by the presence of specific abnormal cells called Reed-Sternberg cells and typically spreads in a predictable pattern through lymph nodes.

Trial ID:
2024-516181-11-00
Protocol code:
VALYM
NCT ID:
NCT04842877
Trial Phase:
Therapeutic exploratory (Phase II)

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