Not yet recruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Urine samples, Biopsies, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Nemtabrutinib is a tablet taken by mouth."
  • "Biopsies, imaging exams, and other tests may be repeated at these visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests nemtabrutinib, a pill taken once a day, for adults with CLL or SLL, cancers that affect white blood cells. It is for people whose cancer did not respond or got worse while taking certain earlier drugs, and who have also received a BCL2 inhibitor.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, have confirmed CLL or SLL, and understand and agree to join the study.
  • Have cancer that did not respond or got worse while taking a covalent BTK inhibitor or pirtobrutinib, drugs used to treat CLL/SLL.
  • Have received a BCL2 inhibitor, another type of cancer drug.
  • Have cancer that needs treatment or is getting worse, with signs that can be measured in lymph nodes, the spleen, blood, or bone marrow.
  • Be able to care for yourself and be out of bed for at least half the day. Be able to swallow and keep down pills.
  • Meet the study’s blood count, kidney, liver, and blood-clotting test limits.
  • Not be pregnant or breastfeeding. If you can become pregnant, use birth control and have a negative blood pregnancy test before treatment.
  • If you have hepatitis B, hepatitis C, or HIV, meet the study’s treatment and virus-control rules.

Who can't join

  • Cancer involving the brain or spinal cord, or a stroke or bleeding inside the skull within the past 6 months.
  • Active hepatitis B or C that does not meet the study rules, active CMV virus infection, or an uncontrolled infection needing treatment throughout the body.
  • Stomach or bowel problems that could keep your body from absorbing the pill.
  • Dangerously high blood pressure, certain serious heart problems, or an abnormal heart test showing a QTcF above 450 milliseconds.
  • An allergy to nemtabrutinib or its ingredients, or a severe ongoing bleeding disorder.
  • Another cancer that is getting worse or needed treatment in the past 2 years, with exceptions for certain skin cancers, very early cancers, and low-risk prostate cancer.
  • Use of certain medicines that interact with the study drug, or cancer treatment, radiation, or a live vaccine too close to starting the study drug.
  • The final exclusion rule in the supplied text is cut off and cannot be summarized.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age \>=18 years. CLL/SLL is extremely rare in patients \< 18 years old. 2. Ability to comprehend the investigational nature of the study and provide informed consent 3. Confirmed diagnosis of CLL or SLL according to International Workshop on CLL (iwCLL) guidelines 1. Coexpression of CD5, CD19, CD20, and CD23 expression and light-chain restriction 2. CLL: clonal B-lymphocytosis \>=5,000 cells/mL OR SLL: lymphadenopathy with the tissue morphology of CLL but that are not leukemic, \<5,000 cells/mL 4. Cohort A: refractoriness to cBTKi defined as lack of response or progressive disease while on therapy Cohort B: refractoriness to pirtobrutinib defined as lack of response or progressive disease while on therapy 5. Prior treatment with a BCL2i 6. Active disease requiring treatment or progressive disease during or after therapy according to iwCLL guidelines 7. Measurable disease characterized by \>=1 of the following: 1. Lymphadenopathy: \>=1 lymph node measuring \>=1.5 cm in the greatest diameter 2. Splenomegaly: spleen measuring \>13 cm in craniocaudal length 3. Lymphocytosis: \>=5,000 B cells/microL 4. Bone marrow infiltration: CLL comprising \>=30% of all cells 8. A female participant is eligible to participate if not pregnant or breastfeeding, and \>=1 of the following conditions applies: Is not a person of childbearing potential (POCBP) OR Is a POCBP and * Uses a contraceptive method * Has a negative highly sensitive serum pregnancy test within 7 days before the first dose of study intervention. 9. The participant has provided documented informed consent for the trial. 10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to the first dose of study intervention. 11. The ability to swallow and retain oral medication Note: Administration of nemtabrutinib is not permitted through a PEG-J tube. 12. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for \>=4 weeks and have undetectable HBV viral load prior to study entry. Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests should include HBsAg, HBcAb, HBsAb . Hepatitis B screening tests are not required unless: * Known history of HBV infection * As mandated by local health authority 13. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative anti-viral therapy \>=4 weeks prior to nemtabrutinib initiation. 14. Participants with HIV are eligible if they meet ALL of the following criteria: * The CD4 count is \>350 cells/microL at screening * The HIV viral load is below the detectable level as per locally available testing * Are on a stable ART regimen for \>=4 weeks prior to study entry Note: ART includes drugs, which are NOT strong CYP3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study). * Are compliant with their ART Note: If the participant has had an AIDS defining opportunistic infection in the past 12 months prior to screening, they are not eligible to be included in the study. 15. Adequate organ function as defined in the following table. Specimens must be collected within 7 days prior to drug initiation. Organ Function Laboratory Values: * Hematological --Absolute neutrophil count (ANC) \>=750/microL (or \>=500/mircoL in participants with documented bone marrow involvement)\* * Platelets \>=50,000/mircoL\* * Hemoglobin \>=8 g/dL\* * Renal * Creatinine \<=1.5 x ULN OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) \>=30 mL/min for participant with creatinine levels \>1.5 x institutional ULN * Hepatic * Total bilirubin \<=1.5 x ULN OR direct bilirubin \<= ULN for participants with total bilirubin levels \>1.5 x ULN * AST (SGOT) and ALT (SGPT) \<=2.5 x ULN * Coagulation * PT, aPTT \<=1.5 x ULN unless participant is receiving anticoagulant therapy ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); ULN=upper limit of normal; INR=international normalized ratio; PT=prothrombin time; aPTT=activated partial thromboplastin time \*Growth factor and/or transfusion support is permissible to meet this requirement if cytopenia is due to bone marrow involvement of CLL EXCLUSION CRITERIA: The participant must be excluded from the study if the participant meets any of the following criteria: 1. Documented CNS involvement 2. Active HBV/HCV infection. See Inclusion Criteria 10 (HBV) and 11 (HCV) for requirements. 3. Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible. 4. Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy). 5. Active, uncontrolled infection requiring systemic therapy, including IV antibiotics during screening. Participants may be rescreened followed completion of IV antibiotic course. 6. Stroke or intracranial hemorrhage within 6 months of screening 7. Hypertensive urgency or emergency 8. Active, clinically significant cardiovascular disease including: * Uncontrolled or symptomatic arrhythmias * Class 3 or 4 congestive heart failure as defined by New York Heart Association Functional Classification * Myocardial infarction, unstable angina or acute coronary syndrome within 6 months of screening. * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place. 9. QTcF \>450 milliseconds based on Fridericia s formula (NOTE: QTcF value may be calculated as the numerical average of up to 3 separate readings for eligibility). 10. Known allergy/sensitivity to nemtabrutinib or any of the excipients (hypromellose acetate succinate, microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, and may include film coat). 11. History of severe bleeding disorders defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding. 12. Known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score \<=6, and PSA \<10 ng/mL), either treated with definitive intent or untreated in active surveillance with stable disease, are not excluded. 13. Currently being treated with the following drugs: * P-gp substrates with a narrow therapeutic index * CYP3A strong inducers * CYP3A strong inhibitors Note: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a participant to be eligible for study enrollment. 14. Has received prior systemic anti-CLL therapy within 3 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) of start of nemtabrutinib. 15. Has received prior radiotherapy within 2 weeks of start of nemtabrutinib or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted. 16. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of nemtabrutinib. Administration of killed vaccines are allowed. 17. Patients requiring ongoing treatment with warfarin within 7 days of start of nemtabrutinib 18. Enrolled on another therapeutic clinical trial for CLL/SLL at the start of nemtabrutinib. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anticancer therapy is prohibited. 19. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) 20. Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications. Note: Biopsy and placement of central venous access devices are not considered major surgery. 21. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Study sites (1)

MD