Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma (NCT04257578) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Acalabrutinib and Anti-CD19 CAR T-cell Therapy for the Treatment of B-cell Lymphoma
United States23 participantsStarted 2020-12-02
Plain-language summary
This phase I/II trial studies the safety of acalabrutinib and axicabtagene ciloleucel in treating patients with B-cell lymphoma. Acalabrutinib may stop the growth of tumor cells by blocking key pathways needed for cell growth. Immunotherapy with axicabtagene ciloleucel is engineered to target a specific surface antigen on lymphoma cells. Acalabrutinib may enhance the efficacy of axicabtagene ciloleucel in treating patients with B-cell lymphoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, and indolent (grade 1-3a) FL
* Criteria must be met for receiving commercial axi-cel per Food and Drug Administration (FDA) label
* \>= 18 years of age
* Patients must be capable of understanding and providing a written informed consent
* Negative serum pregnancy test within 2 days of initiating acalabrutinib for women of childbearing potential (WOCBP), defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
* Fertile male and WOCBP patients must be willing to use highly effective contraceptive methods before, during, and for at least 4 months after the CAR T-cell infusion or within 2 days of acalabrutinib, whichever is longer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Creatine clearance (CrCl) \> 50 mL/min or serum creatinine =\< 2.5
* Total bilirubin =\< 1.5x the upper limit of normal
* Adequate pulmonary function, defined as =\< grade 1 dyspnea and oxygen saturation (SaO2) \>= 92% on room air
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3x the upper limit of normal
* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) of \>= 50% and without evidence for pericardial effusion
* At…
What they're measuring
1
Incidence of adverse events
Timeframe: Up to 30 days post axicabtagene ciloleucel infusion