Seattle, WANCT07194980Now EnrollingIRB Ready

Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Clinical Trial in Seattle, WA

Access cutting-edge recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma treatment through this clinical trial at a research site in Seattle. Study-provided care at no cost to qualified participants.

Sponsored by Fred Hutchinson Cancer Center

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Expert Care in Seattle

Access recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma treatment provided free

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Check if you qualify for this recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma clinical trial in Seattle, WA

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Why Participate?

  • No-Cost Study Care

  • Local to Seattle

    Convenient for WA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Seattle site if eligible
  4. 4Begin participation

About This Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Study in Seattle

This phase II trial studies how well the addition of nemtabrutinib to lisocabtagene maraleucel in treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Nemtabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lisocabtagene maraleucel is a type of treatment called chimeric antigen receptor (CAR) T-cell therapy, in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment. Adding nemtabrutinib to lisocabtagene maraleucel may be an effective treatment for relapsed/refractory CLL/SLL.

Sponsor: Fred Hutchinson Cancer Center

Who Can Participate

Inclusion Criteria

Confirmed diagnosis of CLL/SLL per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) classification
Measurable disease by imaging (lymph node \[LN\] \> 1.5cm) or absolute lymphocyte count (ALC) (\> 5000/μL) or marrow involvement of at least 30% by flow cytometry
Eligible for lisocabtagene maraleucel (liso-cel) as standard-of-care per Food and Drug Administration (FDA) label for CLL/SLL
At least 18 years of age at time of study enrollment
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
The ability to swallow and retain oral medication
NOTE: Administration of nemtabrutinib is not permitted through a percutaneous endoscopic gastro-jejunal (J PEG) tube
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
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 and anti-HBV. Hepatitis B screening tests are not required unless:
Known history of HBV infection,
As mandated by local health authority
Absolute neutrophil count (ANC) ≥ 500/µL
Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed
No lower limit if cytopenia is related to bone marrow involvement
Hemoglobin ≥ 8 g/dL
Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed
No lower limit if cytopenia is related to bone marrow involvement
Platelets ≥ 25 000/µL
Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed
No lower limit if cytopenia is related to bone marrow involvement
Creatinine ≤ 1.5 × upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or CrCl) ≥ 30 mL/min for participant with creatinine levels \> 1.5 × institutional ULN
Creatinine clearance (CrCl) should be calculated per institutional standard
Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
International normalized ratio (INR) OR prothrombin time (PT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Cardiac (echocardiogram \[Echo\] or multi-gated acquisition scan \[MUGA\]) ejection fraction ≥ 40%

Exclusion Criteria

Diagnosis of Richter Transformation
Clinically significant (symptomatic) central nervous system (CNS) involvement at time of study enrollment. Previously treated CNS disease is allowed if the participant is asymptomatic. Incidental findings including positive cerebral spinal fluid (CSF) studies are not exclusionary
Active infection and uncontrolled infection
Active HBV/hepatitis C virus (HCV) infection
Participants must have completed curative anti-viral therapy for HCV at least 4 weeks prior to study enrollment
Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to study enrollment
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
HIV with a detectable viral load or a CD4 count ≤ 350 cells/µL at time of screening
Participants with HIV who do not meet the above criteria are eligible if they are on a stable antiretroviral therapy (ART) regimen (ART must not be strong CYP3A4 inducers) for at least 4 weeks prior to study entry and are compliant with ART are eligible
Patients with an AIDS defining opportunistic infection in the past 12 months prior to screening
Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Corrected QT interval (QTc) prolongation (defined as a QTc \> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
Known allergy/sensitivity to nemtabrutinib or any of the excipients
Known prior progressive disease while on nemtabrutinib
NOTE: Refer to the investigator's brochure (IB) for details regarding prior recipients of nemtabrutinib
History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding
History of a second malignancy
NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
A participant of childbearing potential (POCBP) who has a positive urine pregnancy test within 72 hours prior to study enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for participant to start receiving study medication
Need or anticipation of need for additional bridging therapy in addition to nemtabrutinib
Palliative radiation therapy for less than 2 weeks or the use of prednisone 30mg (or the prednisone equivalent) for a maximum of 5 days is allowed and is not exclusionary
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
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of inactivated vaccines are allowed
Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
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
Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Any condition or history that the study investigator deems not in the best interest of the patient to participate

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Seattle?

Yes, this clinical trial (NCT07194980) has an active research site in Seattle, WA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treatment Options in Seattle, WA

If you're searching for recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma treatment options in Seattle, WA, this clinical trial (NCT07194980) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Seattle research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent chronic lymphocytic leukemia/small lymphocytic lymphoma clinical trials near you to find additional studies recruiting in your area.

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