NCT07796373
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
레지스트리 요약
- 진행 상태
- 모집 전 (NOT_YET_RECRUITING)
- 질환/조건
- Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
- 시험 유형
- 중재 연구 (INTERVENTIONAL)
- 단계
- Phase 2
- 목적
- 치료
- 중재 유형
- 약물
- 개입·치료
- Nemtabrutinib
- Lead Sponsor
- National Heart, Lung, and Blood Institute (NHLBI) (NIH)
캐시 시각: 2026-10-24 01:13:35
요약
Background:
Chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) are diseases in which the body makes too many white blood cells that do not work properly. Because white cells play a role in immune function, people with CLL/SLL may be at greater risk of infections. CLL/SLL can be controlled with drugs, but many people develop resistance, and the treatments stop working.
Objective:
To test a new drug (nemtabrutinib) in people with CLL/SLL.
Eligibility:
People aged 18 years or older with CLL/SLL that persists despite treatment.
Design:
Participants will be screened. They will have imaging scans, blood and urine tests, and a test of their heart function. They will have a bone marrow biopsy: a sample of tissue and fluids will be drawn from inside their hip bone. They may also have a sample cut from a swollen lymph node, if one is safe to access.
Nemtabrutinib is a tablet taken by mouth. Participants will take the drug once a day at home in 4-week cycles. They will have clinic visits at least every 4 weeks for the first 6 months and then every 3 months after that.
Biopsies, imaging exams, and other tests may be repeated at these visits. Participants may also undergo lymphapheresis: Blood will be drawn from a tube inserted into a vein. The blood will pass through a machine that separates out cancer and immune cells. The remaining blood will be returned to the body through a different tube.
Participants may stay in the study as long as the drug is helping them.
Chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) are diseases in which the body makes too many white blood cells that do not work properly. Because white cells play a role in immune function, people with CLL/SLL may be at greater risk of infections. CLL/SLL can be controlled with drugs, but many people develop resistance, and the treatments stop working.
Objective:
To test a new drug (nemtabrutinib) in people with CLL/SLL.
Eligibility:
People aged 18 years or older with CLL/SLL that persists despite treatment.
Design:
Participants will be screened. They will have imaging scans, blood and urine tests, and a test of their heart function. They will have a bone marrow biopsy: a sample of tissue and fluids will be drawn from inside their hip bone. They may also have a sample cut from a swollen lymph node, if one is safe to access.
Nemtabrutinib is a tablet taken by mouth. Participants will take the drug once a day at home in 4-week cycles. They will have clinic visits at least every 4 weeks for the first 6 months and then every 3 months after that.
Biopsies, imaging exams, and other tests may be repeated at these visits. Participants may also undergo lymphapheresis: Blood will be drawn from a tube inserted into a vein. The blood will pass through a machine that separates out cancer and immune cells. The remaining blood will be returned to the body through a different tube.
Participants may stay in the study as long as the drug is helping them.
