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Lisaftoclax

Clinical trials are investigating Lisaftoclax in several blood cancers, including acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, and higher-risk myelodysplastic syndrome. These studies are looking at safety, efficacy, and survival outcomes in newly diagnosed, previously treated, relapsed, and refractory patients.

Table of Contents

Clinical trial overview

These studies are testing Lisaftoclax in several blood cancers, mainly acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, and higher-risk myelodysplastic syndrome.[1][2][3][4][5]

The trial list includes Phase 1, Phase Ib/II, and Phase 3 studies, which means the research ranges from early safety and dose finding to larger studies that compare how well treatments work.[1][2][3][4][5]

All listed studies are interventional, which means patients receive a study treatment or comparison treatment rather than only being observed.[1][2][3][4][5]

Newly diagnosed acute myeloid leukemia study

NCT06389292 is a Phase 3 study in newly diagnosed acute myeloid leukemia with 354 planned participants and an authorised status.[1]

This study is testing Lisaftoclax with azacitidine against placebo with azacitidine in patients who are elderly or not able to receive standard induction chemotherapy, which is intensive first-line treatment for AML.[1]

The main endpoint is overall survival, meaning the time from randomization until death from any cause.[1]

Newly diagnosed CLL/SLL studies

NCT06319456 is a worldwide Phase 3 study in newly diagnosed chronic lymphocytic leukemia/small lymphocytic lymphoma with 244 planned participants and an authorised status.[2]

This study compares Lisaftoclax plus acalabrutinib with immunochemotherapy, which is treatment that combines chemotherapy and immunotherapy drugs.[2]

The main endpoint is progression-free survival, measured by an Independent Review Committee, meaning the time from randomization until the disease gets worse or the patient dies, whichever happens first.[2]

Previously treated and relapsed CLL/SLL studies

NCT06104566 is a global multicenter Phase 3 study in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma with 455 planned participants and an authorised status.[3]

This study tests Lisaftoclax with a BTKi, which stands for Bruton tyrosine kinase inhibitor, a type of targeted treatment used in CLL/SLL, and compares that combination with BTKi alone.[3]

NCT2024-515654-25-00 is a Phase 1 study in relapsed and/or refractory CLL/SLL with 234 planned participants and an authorised status.[5]

Relapsed means the disease came back after treatment, and refractory means the disease did not respond well to treatment.[5]

This early study looks at Lisaftoclax alone or in combination with other treatments such as rituximab, acalabrutinib, ibrutinib, or zanubrutinib, and it aims to define safety, tolerability, dose-limiting toxicities, the maximum tolerated dose, and the recommended phase 2 dose.[5]

The Phase II part also plans to measure efficacy outcomes such as ORR, complete response, partial response, duration of response, PFS, OS, MRD, and time to complete response or MRD negativity.[5]

Higher-risk myelodysplastic syndrome study

NCT06641414 is a Phase 3 study in newly diagnosed higher-risk myelodysplastic syndrome with 508 planned participants and an authorised status.[4]

This study compares Lisaftoclax plus azacitidine with placebo plus azacitidine in adults with higher-risk MDS.[4]

The record lists the primary outcome as unavailable in the provided data, but the trial is described as an efficacy study.[4]

Main endpoints and what they mean

Endpoints are the main results a study wants to measure.[1][2][3][4][5]

  • Overall survival (OS) measures how long patients live after randomization, no matter what caused death.[1]

  • Progression-free survival (PFS) measures how long patients stay without disease worsening or death.[2][3]

  • Safety and tolerability show how well patients can receive the treatment and what problems may appear during treatment.[5]

  • Maximum tolerated dose is the highest dose that can be given without unacceptable side effects in the study setting.[5]

  • Minimal residual disease is a very small amount of cancer that may remain after treatment and can be measured with sensitive tests.[5]

Trial ID Phase Condition studied Status Enrollment
NCT06389292 Phase 3 Newly diagnosed acute myeloid leukemia Authorised 354
NCT06319456 Phase 3 Newly diagnosed chronic lymphocytic leukemia/small lymphocytic lymphoma Authorised 244
NCT06104566 Phase 3 Previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma Authorised 455
NCT06641414 Phase 3 Newly diagnosed higher-risk myelodysplastic syndrome Authorised 508
2024-515654-25-00 Phase 1 Relapsed and/or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma Authorised 234

FAQ

  • What is being studied in Lisaftoclax clinical trials? The trials are studying Lisaftoclax in blood cancers such as acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, and higher-risk myelodysplastic syndrome. Some studies test Lisaftoclax alone, while others test it with other treatments.
  • Who can join these trials? Eligibility depends on the study. The trials include newly diagnosed adults, older patients, people not fit for standard induction chemotherapy, and patients with relapsed, refractory, or previously treated disease.
  • What phases are the Lisaftoclax trials in? The listed studies include Phase 1, Phase Ib/II, and Phase 3 trials. Phase 1 studies focus more on safety and dose finding, while Phase 3 studies compare how well treatments work in larger groups.
  • What outcomes are the trials measuring? The studies measure outcomes such as overall survival, progression-free survival, response rates, safety, tolerability, and minimum residual disease. These help show whether the treatment works and how long patients stay without disease worsening.
  • Are Lisaftoclax trials only for one cancer type? No. The trials cover more than one condition. They include leukemia and lymphoma studies, plus one study in higher-risk myelodysplastic syndrome.

Ongoing Clinical Trials on Lisaftoclax

  • Study on the Effectiveness of Lisaftoclax and Azacitidine in Adults with Newly Diagnosed Higher Risk Myelodysplastic Syndrome

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Finland France Germany +7

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

    Recruiting

    1 1 1 1
    Investigated drugs:
    Bulgaria Czechia Spain

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

    Recruiting

    1 1 1
    Investigated drugs:
    Hungary Poland

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

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Hungary +5

  • Study of Lisaftoclax combined with azacitidine for elderly patients with newly diagnosed acute myeloid leukemia

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Italy Poland Spain

Glossary

  • Acute myeloid leukemia (AML): A fast-growing cancer of the blood and bone marrow.
  • Chronic lymphocytic leukemia (CLL): A slow-growing blood cancer that affects a type of white blood cell called lymphocytes.
  • Small lymphocytic lymphoma (SLL): A cancer closely related to CLL, but it mainly shows up in the lymph nodes.
  • Myelodysplastic syndrome (MDS): A group of disorders where the bone marrow does not make healthy blood cells normally.
  • Phase 1: An early study phase that mainly looks at safety, side effects, and the best dose.
  • Phase 3: A later study phase with more patients, used to compare treatments and measure how well they work.
  • Overall survival (OS): The length of time from randomization until death from any cause.
  • Progression-free survival (PFS): The length of time after randomization during which the disease does not get worse.
  • Randomization: A process that assigns patients to treatment groups by chance.
  • Independent Review Committee (IRC): A group that reviews study results in a separate, unbiased way.
  • Minimal residual disease (MRD): A very small number of cancer cells that may remain after treatment.
  • Objective response rate (ORR): The percentage of patients whose cancer shrinks or disappears during the study.

References