Study of TL-895 and Navtemadlin for Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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What is this study about?

This clinical trial is focused on studying certain types of blood cancers, specifically B-Cell Malignancies, which include Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). The trial is testing a new treatment called TL-895, which is taken as a film-coated tablet. The study also involves a combination therapy with another medication called Navtemadlin for some participants. The purpose of the study is to explore how well these treatments work in people who have either not responded to previous treatments or are newly diagnosed.

Participants in the study will receive either the TL-895 treatment alone or in combination with Navtemadlin. The study will observe how the cancer responds to these treatments over time. Some participants will receive a placebo to compare the effects. The trial is divided into different parts, with some focusing on those who have not been treated before and others on those whose cancer has returned or not responded to previous treatments.

The study will monitor participants for any changes in their condition and any side effects they might experience. The goal is to determine the overall response rate, which means how many people see a reduction in their cancer symptoms. The trial will also look at how long any positive effects last and assess the safety of the treatments. This research aims to find more effective ways to treat these types of blood cancers and improve outcomes for patients in the future.

1 initial visit

Upon joining the clinical trial, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the study. These assessments may include blood tests, physical examinations, and a review of your medical history.

2 treatment assignment

Once eligibility is confirmed, you will be assigned to a treatment group. The study involves the use of a medication called TL-895, which is administered in the form of a film-coated tablet taken orally. The dosage and frequency will be determined based on the specific phase of the trial you are participating in.

3 medication administration

You will take the TL-895 tablets as instructed by the study team. The medication is taken by mouth, and you will be provided with detailed instructions on how and when to take it. It is important to follow these instructions carefully to ensure the effectiveness of the treatment.

4 regular follow-up visits

Throughout the trial, you will have regular follow-up visits. These visits are crucial for monitoring your health and the effects of the medication. During these visits, you may undergo various tests, including blood tests and other assessments, to evaluate your response to the treatment.

5 end of treatment

At the end of the treatment period, you will have a final visit. This visit will include a comprehensive evaluation of your health and the overall response to the medication. The study team will discuss the results with you and provide any necessary follow-up care instructions.

Who Can Join the Study?

  • Must be an adult who is 18 years or older.
  • Can be male or female.
  • Must have one of the following conditions:
    • Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that has come back after treatment or did not respond to treatment (relapsed/refractory).
    • CLL or SLL that has not been treated before (treatment-naive).

Who Cannot Join the Study?

  • Patients with any other type of cancer that is not related to B Cell Malignancies or Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) cannot participate.
  • Patients who have had a different cancer in the past, unless it was treated and has not come back for at least 5 years, are excluded.
  • Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with active infections that require treatment with antibiotics, antivirals, or antifungals are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received another investigational drug within the last 4 weeks are not eligible.
  • Patients with known allergies to the study drug or its components cannot join the study.
  • Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body, are excluded.
  • Patients with a history of drug or alcohol abuse within the past year are not eligible.
  • Patients who have had a major surgery within the last 4 weeks cannot participate.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
University Of Debrecen Debrecen Hungary
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Pratia S.A. Skorzewo Poland
Snyjsuf Wlkzjafkii W Oplim Svo z oyrh Opole Poland
Mhmbdrufy Iqpqsxwxxd Cjglmpyt Sfpzepde Szm z oguy Warsaw Poland

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

Trial status

Country Status Recruitment Start
Hungary Hungary
Not recruiting
01.09.2016
Poland Poland
Not recruiting
01.09.2016

Trial locations

TL-895 is a medication being tested in this clinical trial. It is designed to help people with certain types of blood cancers, specifically B-cell malignancies. These are cancers that affect a type of white blood cell called B-cells, which are part of the immune system. The trial is looking at how well TL-895 works on its own for people whose cancer has come back or hasn’t responded to other treatments. The goal is to see if TL-895 can help reduce the cancer or stop it from growing.

Navtemadlin is another medication being studied in this trial. It is being tested in combination with TL-895 for people with a type of blood cancer called Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). These are slow-growing cancers that affect the lymphocytes, another type of white blood cell. The trial aims to find out if using Navtemadlin together with TL-895 can improve treatment outcomes for patients who are either newly diagnosed or have had their cancer return after previous treatments. The researchers want to see if this combination can help control the cancer more effectively.

B Cell Malignancies – B cell malignancies are a group of cancers that affect B lymphocytes, which are a type of white blood cell responsible for producing antibodies. These malignancies can include various types of lymphomas and leukemias. The disease often begins with the abnormal growth of B cells, leading to their accumulation in the lymph nodes, blood, or other tissues. As the disease progresses, it can cause symptoms such as swollen lymph nodes, fatigue, fever, and weight loss. The progression can vary depending on the specific type of B cell malignancy. Over time, the abnormal B cells can interfere with normal blood cell production and immune function.

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects the blood and bone marrow, characterized by the slow accumulation of abnormal lymphocytes, a type of white blood cell. It typically progresses slowly and may not cause symptoms for years. As the disease advances, it can lead to symptoms such as swollen lymph nodes, fatigue, fever, and weight loss. The abnormal lymphocytes can crowd out healthy blood cells, leading to anemia, infections, and bleeding problems. CLL often affects older adults and is the most common type of leukemia in this age group. The progression of CLL can vary widely among individuals.

Small Lymphocytic Lymphoma – Small Lymphocytic Lymphoma (SLL) is a type of non-Hodgkin lymphoma that is closely related to Chronic Lymphocytic Leukemia (CLL), involving the same type of cancerous B lymphocytes. Unlike CLL, which primarily affects the blood and bone marrow, SLL mainly involves the lymph nodes. The disease progresses slowly and may not cause symptoms initially. As it advances, it can lead to swollen lymph nodes, fatigue, fever, and weight loss. The abnormal B cells can accumulate in the lymph nodes and other organs, potentially affecting their function. SLL and CLL are considered different manifestations of the same disease.

Trial ID:
2024-516691-14-00
Protocol code:
MS200662_0001
NCT ID:
NCT02825836
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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