Study on Golcadomide and Valemetostat Tosylate for Patients with Relapsed or Refractory Non-Hodgkin Lymphomas

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What is this study about?

This clinical trial is focused on studying a group of diseases known as Non-Hodgkin Lymphomas (NHL), which are types of cancer that affect the lymphatic system. The study is particularly interested in cases where the disease has returned or has not responded to previous treatments, known as relapsed or refractory Non-Hodgkin Lymphomas. The specific types of NHL being studied include Marginal Zone Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Primary Central Nervous System Lymphoma, and Follicular B-Cell Non-Hodgkin’s Lymphoma.

The trial will investigate a new medication called Golcadomide (also known by its code name CC-99282), which is taken orally in capsule form. This medication will be tested both on its own and in combination with other treatments for NHL, including Rituximab, Obinutuzumab, Tafasitamab, and Valemetostat Tosylate. Rituximab is a monoclonal antibody, which is a type of protein made in the laboratory that can bind to substances in the body, including cancer cells. The purpose of the study is to determine the safety and tolerability of Golcadomide alone and in combination with these other treatments, as well as to find the best dose to use in future studies.

Participants in the study will receive the medication and be monitored for any side effects or changes in their condition. The study will also look at how the body processes the medication and its preliminary effectiveness in treating the disease. The trial is designed to gather important information that could lead to new treatment options for people with relapsed or refractory NHL.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include being 18 years or older, having a history of certain types of non-Hodgkin lymphomas, and meeting specific health parameters.

2 treatment phase 1

The first phase of treatment involves taking CC-99282 alone. This is an oral medication taken in capsule form.

The dosage and frequency are determined based on individual health assessments and the study’s guidelines.

3 combination treatment

If eligible, the next phase involves a combination treatment. CC-99282 is administered alongside other medications such as rituximab, obinutuzumab, tafasitamab, or valemetostat.

Rituximab is given intravenously, while other medications may be taken orally or intravenously, depending on the specific combination.

4 monitoring and evaluation

Throughout the trial, regular monitoring is conducted. This includes checking vital signs, performing laboratory tests, and assessing overall health.

The effectiveness of the treatment is evaluated using specific criteria to measure response rates and survival outcomes.

5 completion and follow-up

Upon completion of the treatment cycles, a final assessment is conducted to evaluate the overall response to the treatment.

Follow-up visits may be scheduled to monitor long-term health outcomes and any potential side effects.

Who Can Join the Study?

The person must be at least 18 years old when they sign the consent form to join the study.
The person must have a history of a type of cancer called NHL (Non-Hodgkin’s Lymphoma), which includes specific types like DLBCL (Diffuse Large B-Cell Lymphoma), FL (Follicular Lymphoma), MZL (Marginal Zone Lymphoma), MCL (Mantle Cell Lymphoma), and PCNSL (Primary Central Nervous System Lymphoma). The disease must have come back or not responded to treatment.
The person must have an ECOG performance status of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 2 meaning they can do some activities but may need rest.
The person must have certain blood test results:
- Absolute neutrophil count (ANC): At least 1.5 x 10^9/L, or at least 1 x 10^9/L if the bone marrow is involved, without support from growth factors for 7 days (or 14 days if using a specific type called pegfilgastrim).
- Hemoglobin (Hgb): At least 8 g/dL.
- Platelets: At least 75 x 10^9/L, or at least 50 x 10^9/L if the bone marrow is involved, without needing a transfusion for 7 days.
- Serum bilirubin: No more than 1.5 times the upper limit of normal.
- AST/SGOT and ALT/SGPT: No more than 2.5 times the upper limit of normal. These are liver enzymes.
- Estimated serum creatinine clearance: More than 30 mL/min, which measures kidney function. For certain groups, it must be at least 45 mL/min.
The person must agree to follow the CC-99282 Pregnancy Prevention Plan to prevent pregnancy during the study.

Who Cannot Join the Study?

Patients with other types of cancer that are not listed in the study.
Patients who have serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent heart attack or severe heart problems.
Patients who have an active infection that requires treatment.
Patients who have a history of allergic reactions to the study drugs.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have a mental health condition that could affect their ability to participate.
Patients who have had a major surgery within the last 4 weeks.
Patients who have received certain treatments for their lymphoma within a specific time frame before the study.
Patients who have a known history of HIV, hepatitis B, or hepatitis C.
Patients who have any other condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Henri Becquerel	Rouen	France
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Rigshospitalet	Copenhagen	Denmark
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Anhaly Uviqpqyebn Hlssbguw	Aarhus	Denmark
Aaatkbf Uhfyb Sfkkluabq Ltbyee Db Bevfbic	Bologna	Italy
Asdmbnj Ojdyhfvcion Pwdl Guqjsumf Xrndw	Bergamo	Italy
Ifmcxify Cismge Dzqhhpucbvpdimqfu	L'hospitalet De Llobregat	Spain
Flyjxzxie Phot Li Ihlktzgtppscg Bxwrwmdcp Dli Hrpjvfmq Uuxjhlfxztkcy Lv Pxp	Madrid	Spain
Howvenjx Vaax dxbxlhwu	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	03.05.2019
France	Not recruiting	03.05.2019
Italy	Not recruiting	03.05.2019
Spain	Not recruiting	03.05.2019

Trial locations

Investigated drugs:

CC-99282 is an experimental small molecule being tested for its safety and effectiveness in treating relapsed or refractory non-Hodgkin lymphomas. It is taken orally and is being studied both on its own and in combination with other medications to see how well it works and how the body processes it.

Rituximab is a medication used to treat certain types of cancer, including non-Hodgkin lymphomas. It works by targeting specific cells in the immune system to help the body fight cancer.

Obinutuzumab is another medication used to treat non-Hodgkin lymphomas. It is designed to attach to certain cells in the immune system, helping to destroy cancer cells.

Tafasitamab is a medication that targets specific proteins on the surface of cancer cells in non-Hodgkin lymphomas. It helps the immune system to identify and attack these cancer cells.

Valemetostat is an investigational drug being studied for its potential to treat non-Hodgkin lymphomas. It may be used alone or in combination with rituximab to see if it can improve treatment outcomes.

Investigated diseases:

Marginal Zone Lymphoma – This is a type of non-Hodgkin’s lymphoma that originates in the marginal zone of lymphoid tissue, which is part of the immune system. It typically progresses slowly and may initially present with symptoms such as swollen lymph nodes or fatigue. Over time, it can spread to other parts of the body, including the bone marrow and spleen.

Diffuse Large B-Cell Lymphoma – This is an aggressive form of non-Hodgkin’s lymphoma characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. It often presents with symptoms like fever, night sweats, and weight loss. The disease can progress quickly, requiring prompt medical attention.

Mantle Cell Lymphoma – This is a rare type of non-Hodgkin’s lymphoma that arises from B-cells in the outer edge of a lymph node follicle, known as the mantle zone. It is typically aggressive and may present with symptoms such as swollen lymph nodes, fever, and fatigue. The disease can spread to other parts of the body, including the bone marrow and gastrointestinal tract.

Primary Central Nervous System Lymphoma – This is a rare form of non-Hodgkin’s lymphoma that occurs in the brain, spinal cord, or eye. It can cause neurological symptoms such as headaches, seizures, or changes in personality. The disease is confined to the central nervous system and does not usually spread to other parts of the body.

Follicular B-Cell Non-Hodgkin’s Lymphoma – This is a slow-growing type of non-Hodgkin’s lymphoma that originates from B-cells in the lymph nodes. It often presents with painless swelling of lymph nodes and may progress over several years. The disease can eventually spread to other organs, including the bone marrow and spleen.

Trial ID:

2024-515690-10-00

Protocol code:

CC-99282-NHL-001

NCT ID:

NCT03930953

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Golcadomide and Valemetostat Tosylate for Patients with Relapsed or Refractory Non-Hodgkin Lymphomas

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