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Clinical Trials for B-cell Small Lymphocytic Lymphoma

This article provides detailed information about 24 ongoing clinical trials investigating new treatments for B-cell small lymphocytic lymphoma (SLL). These studies are testing various approaches including CAR T-cell therapies, targeted medications, and combination treatments across multiple countries in Europe and beyond.

Clinical trial locations

Long-Term Safety Study of BCMACP03, BCN-CP01, and 19CP02 for Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, CLL, SLL, or Multiple Myeloma

This trial investigates the long-term safety of CAR T-cell therapies in patients with relapsed or refractory blood cancers. Eligible participants must have previously received GLPG CAR T-cell therapy in a clinical trial or managed access program.

Main inclusion criteria: Patients must have received prior treatment with GLPG CAR T-cell therapy and be willing to provide informed consent. The study accepts both men and women.

Main exclusion criteria: Patients who have not experienced disease relapse or progression after treatment are excluded.

Trial focus: The study evaluates the safety of CAR T-cell products for up to 15 years after infusion. Researchers will monitor adverse events, track CAR transgene levels in blood, assess disease progression status, and measure overall survival. This long-term follow-up is essential for understanding the durability and safety profile of these novel therapies.

Investigational treatment: GLPG CAR T-cell therapies use modified T-cells from the patient’s immune system to recognize and attack cancer cells. These cells are taken from the patient, genetically altered in a laboratory, and infused back into the patient’s bloodstream.

Study Comparing BGB-16673 to Drug Combinations for Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Treated with BTK and BCL2 Inhibitors

This trial compares a new medication called BGB-16673 against standard treatment combinations for patients whose disease has returned or not responded after receiving BTK and BCL2 inhibitors.

Main inclusion criteria: Patients must have confirmed diagnosis of CLL or SLL requiring treatment and have previously received both BTK and BCL2 inhibitor therapy. They must be at least 18 years old with an ECOG performance status of 0-2, indicating reasonable ability to perform daily activities. Adequate organ and bone marrow function is required.

Main exclusion criteria: Patients with other types of cancer or those unable to follow study procedures are excluded.

Trial focus: The study will monitor progression-free survival, which measures how long patients live without their disease worsening. Researchers will also track overall survival, disease response rates, and safety profiles to determine whether BGB-16673 offers advantages over current treatment options.

Investigational treatment: BGB-16673 is taken orally and targets specific pathways in cancer cells to stop their growth. It is being compared to combinations including Idelalisib plus Rituximab, Bendamustine plus Rituximab, or Venetoclax plus Rituximab.

Study Comparing Nemtabrutinib and Venetoclax with Venetoclax and Rituximab for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

This study tests whether combining Nemtabrutinib with Venetoclax is more effective than the standard combination of Venetoclax with Rituximab for patients whose disease has returned or not responded to previous treatments.

Main inclusion criteria: Patients must have confirmed CLL or SLL requiring treatment and have experienced relapse or lack of response to at least one prior therapy. They must have adequate organ function, be at least 18 years old, and have an ECOG performance status of 0-2. Female patients of childbearing potential must use effective contraception.

Main exclusion criteria: Patients with severe medical conditions that could interfere with the study or those who are pregnant or breastfeeding are excluded.

Trial focus: The primary goal is to measure progression-free survival and compare it between the two treatment arms. The study will also assess overall survival, response duration, and safety through regular monitoring of health indicators and side effects.

Investigational treatment: Nemtabrutinib is an oral medication being studied for safety and tolerability in combination with Venetoclax. Venetoclax helps kill cancer cells by targeting a specific survival protein, while Rituximab is an antibody therapy that marks cancer cells for destruction by the immune system.

Study Comparing Nemtabrutinib, Ibrutinib, and Acalabrutinib for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This trial evaluates a new treatment called Nemtabrutinib against two established medications, Ibrutinib and Acalabrutinib, in patients who have not yet received treatment for their disease.

Main inclusion criteria: Patients must have confirmed CLL or SLL with active disease requiring treatment and at least one marker of disease presence. An ECOG performance status of 0-2 is required. Patients must be able to swallow oral medication and have adequate kidney, liver, and blood function. Those with hepatitis B or C must meet specific viral load criteria.

Main exclusion criteria: Patients who have already received treatment for CLL or SLL cannot participate.

Trial focus: The study will compare objective response rates and progression-free survival across the three treatment arms. Regular monitoring will assess how well each medication controls the disease and evaluate any side effects. This information will help determine if Nemtabrutinib offers benefits over current standard treatments.

Investigational treatment: All three medications are taken orally as tablets and work by blocking specific proteins that help cancer cells grow. Nemtabrutinib is the investigational drug being compared to Ibrutinib and Acalabrutinib, which are already used in clinical practice.

Study of Ibrutinib for Treating Autoimmune Hemolytic Anemia in Patients with Chronic Lymphocytic Leukemia or Similar Conditions

This study focuses on using Ibrutinib to treat autoimmune hemolytic anemia in patients with CLL, SLL, or CLL-like conditions.

Main inclusion criteria: Patients must have CLL, SLL, or CLL-like monoclonal B-cell lymphocytosis according to specific guidelines. They must have active autoimmune hemolytic anemia that has either returned after steroid treatment, not responded to steroids within 3 weeks, or requires ongoing steroids. Patients must be over 18 years old with an ECOG performance status of 2 or less and have adequate kidney and liver function.

Main exclusion criteria: Patients without these specific conditions are excluded.

Trial focus: The primary endpoint is the autoimmune hemolytic anemia overall response rate after 6 cycles of treatment (each cycle is 28 days). The study will also assess responses after 3 and 12 cycles, evaluate quality of life, and monitor safety throughout the treatment period.

Investigational treatment: Ibrutinib is taken orally and works by blocking a protein that helps cancer cells grow and survive. In this study, it is being evaluated for its ability to manage autoimmune hemolytic anemia, a condition where the immune system destroys red blood cells.

Study of Lisaftoclax Alone or with Drug Combination for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This trial investigates Lisaftoclax (APG-2575) used alone or combined with other medications for patients whose disease has returned or not responded to previous treatments.

Main inclusion criteria: Patients must be at least 18 years old with confirmed CLL or SLL requiring treatment after experiencing relapse or lack of response to at least one prior therapy. They must have measurable disease, an ECOG performance status of 0-2, and adequate bone marrow, kidney, and liver function. Effective contraception is required for both male and female patients of childbearing potential.

Main exclusion criteria: Patients with other serious health conditions, those who are pregnant or breastfeeding, or those with recent major surgery or active infections are excluded.

Trial focus: The study aims to determine the maximum tolerated dose of Lisaftoclax and assess its safety when used alone or with other medications including Rituximab, Acalabrutinib, Ibrutinib, or Zanubrutinib. Researchers will monitor treatment response, side effects, and overall effectiveness.

Investigational treatment: Lisaftoclax is taken orally and works by blocking a protein that helps cancer cells survive. The combination therapies include Rituximab (given intravenously), and oral medications Acalabrutinib, Ibrutinib, or Zanubrutinib.

Study of Lisaftoclax and Acalabrutinib for Patients with Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This study tests the combination of Lisaftoclax and Acalabrutinib against standard immunochemotherapy in patients who have not yet received treatment.

Main inclusion criteria: Patients must be at least 18 years old with confirmed CLL or SLL requiring treatment. They must have measurable disease, an ECOG performance status of 0-2, and adequate bone marrow, liver, and kidney function. Female patients of childbearing potential must have negative pregnancy tests and use effective contraception.

Main exclusion criteria: Patients with other types of cancer, those who are pregnant or breastfeeding, or those with serious medical conditions are excluded.

Trial focus: The study will compare progression-free survival between the Lisaftoclax plus Acalabrutinib combination and standard immunochemotherapy. Regular monitoring will assess disease response, treatment tolerability, and overall effectiveness to determine if the new combination offers advantages over current standard treatment.

Investigational treatment: Both Lisaftoclax and Acalabrutinib are taken orally as tablets. Lisaftoclax blocks a protein that helps cancer cells survive, while Acalabrutinib inhibits an enzyme involved in cancer cell growth. The comparison arm receives standard immunochemotherapy, which combines chemotherapy with immune-boosting medications.

Study on CLIC-1901 CAR T-cells and Tocilizumab for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma

This trial tests CLIC-1901 CAR T-cell therapy for patients with blood cancers that have returned or not responded to previous treatments.

Main inclusion criteria: Patients must be between 1 and 70 years old with relapsed or refractory disease. They must have a life expectancy of at least 12 weeks and adequate organ function, including lung function at least 40% of expected and heart function above 45%. Liver and kidney function must meet specific requirements. Patients must be able to swallow oral medication and agree to use effective contraception.

Main exclusion criteria: Patients with certain other cancers or those unable to follow study procedures are excluded.

Trial focus: The study will assess the safety and feasibility of CLIC-1901 CAR T-cell therapy. Researchers will monitor how well the treatment works, track any side effects, and evaluate overall health outcomes. The goal is to understand if this approach can provide effective treatment for patients whose cancer has not responded to other therapies.

Investigational treatment: CLIC-1901 consists of the patient’s own immune cells that are modified in a laboratory to better recognize and attack cancer cells expressing the CD19 protein. The modified cells are infused back into the patient. Tocilizumab may be used to manage potential side effects.

Study on Ibrutinib and Venetoclax for Patients with Untreated Chronic Lymphocytic Leukemia

This trial evaluates customized dosing of Ibrutinib alone or combined with Venetoclax for patients who have not previously received treatment.

Main inclusion criteria: Patients must have confirmed CLL or SLL meeting specific diagnostic criteria with active disease requiring treatment. They must have an ECOG performance status of 0-2 and adequate blood, liver, and kidney function. Specific criteria vary between treatment arms, with some requiring stricter organ function parameters.

Main exclusion criteria: Patients who have received previous treatment for CLL or SLL are excluded.

Trial focus: The study explores whether tailoring treatment dosage based on individual patient response can maintain effectiveness while potentially reducing side effects. Researchers will monitor disease response, progression-free survival, and safety, comparing results to historical data from previous trials.

Investigational treatment: Ibrutinib is taken orally as capsules and works by blocking a protein essential for cancer cell growth. Venetoclax is also taken orally and promotes cancer cell death by inhibiting a survival protein. The study tests various dosing strategies to optimize treatment outcomes.

Study on Lisaftoclax and Acalabrutinib for Patients with Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This study tests whether adding Lisaftoclax to ongoing Acalabrutinib treatment can improve outcomes for patients who have been taking Acalabrutinib alone for at least 12 months.

Main inclusion criteria: Patients must be at least 18 years old with CLL or SLL and have been treated with Acalabrutinib alone for at least 12 months with stable disease or partial response and certain risk factors. An ECOG performance status of 0-2 is required, along with adequate bone marrow, kidney, and liver function. Patients must provide written consent and follow study requirements.

Main exclusion criteria: Patients not previously treated with Acalabrutinib or those with medical conditions other than CLL or SLL are excluded.

Trial focus: The primary goal is to determine whether adding Lisaftoclax to Acalabrutinib therapy can extend progression-free survival compared to continuing Acalabrutinib alone. Regular assessments will monitor disease status, treatment effectiveness, and safety.

Investigational treatment: Lisaftoclax is taken orally and works by inhibiting a protein that helps cancer cells survive. Acalabrutinib, also oral, blocks an enzyme important for cancer cell growth. The study tests whether combining these two targeted therapies provides better disease control.

Summary

This overview presents 10 of the 24 ongoing clinical trials investigating treatments for B-cell small lymphocytic lymphoma. These studies represent diverse approaches including novel CAR T-cell therapies, new targeted medications, and combination treatments.

Several notable patterns emerge from these trials. Many studies focus on BTK inhibitors (such as Ibrutinib, Acalabrutinib, and Nemtabrutinib) and BCL-2 inhibitors (particularly Venetoclax), either alone or in combination. Multiple trials are testing these agents in patients who have either received no prior treatment or whose disease has returned after previous therapy.

Geographically, the trials are concentrated across Europe, with strong representation in countries including Germany, France, Italy, Spain, Belgium, Poland, and the Czech Republic. Several trials are international, recruiting across multiple European countries.

The studies employ various designs, from dose-finding studies to randomized comparisons between new treatments and established standards. Many trials emphasize personalized approaches, such as adjusting treatment duration based on measurable residual disease levels or tailoring dosages to individual patient responses.

For patients considering participation in these trials, it is important to discuss eligibility criteria, potential benefits, and risks with their healthcare providers. The trials offer access to novel treatments that may not otherwise be available and contribute to advancing knowledge about optimal management of this condition.

Ongoing Clinical Trials on B-cell small lymphocytic lymphoma

  • Study Comparing Nemtabrutinib, Ibrutinib, and Acalabrutinib for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark Germany Greece Norway +4

  • A Study Comparing BGB-16673 to Pirtobrutinib for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Has Returned or Not Responded

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Italy The Netherlands +4

  • Study of NX-5948 in adults with relapsed or resistant chronic lymphocytic leukemia and small lymphocytic lymphoma who previously received BTK inhibitor and BCL-2 inhibitor treatment

    Recruiting

    2 1 1
    Investigated diseases:
    France Hungary Italy Poland

  • A study comparing BGB-11417 and zanubrutinib with venetoclax and acalabrutinib for patients with previously untreated chronic lymphocytic leukemia

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Italy The Netherlands Poland +3

  • Study on Venetoclax, Obinutuzumab, and Pirtobrutinib for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +8

  • Study on Zanubrutinib and Obinutuzumab for Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Ibrutinib and Obinutuzumab for Patients with Chronic Lymphocytic Leukemia Who Have Not Received Treatment Before

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Ibrutinib and Venetoclax for Patients with Untreated Chronic Lymphocytic Leukemia

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Hungary Italy Poland Spain

  • Study on Venetoclax and Epcoritamab for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Germany The Netherlands

  • Phase 3 Randomized Study of Rituximab plus Venetoclax for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Patients

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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