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โ† Trials
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Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

RecruitingPhase 2Ages 18 Years - anyAllCity of Hope Medical Center
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In plain words

What the trial is, and whether it could suit you

This phase II trial studies the side effects of acalabrutinib, obinutuzumab, and glofitamab and how well they work together for treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cel

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: \>= 18 years * Eastern Cooperative Oncology Group (ECOG) =\< 2 * Histologically confirmed diagnosis of mantle cell lymphoma according to the World Health Organization (WHO) classification * Relapsed or refractory disease after at least 1 prior line of systemic therapy * Relapse must have been confirmed histologically with hematopathology review at the participating institution. Exceptions may be granted with study PI approval * Tumor must be positive for CD20 by immunohistochemistry or flow cytometry after the most recent therapy * Active disease requiring treatment per treating physician's decision * Radiographically measurable disease by Lugano criteria (e.g., one or more nodal sites of disease \>= 1.5 cm and/or extranodal sites of disease \>= 1.0 cm in longest dimension) * If measurable bone marrow involvement or circulating disease has been confirmed in the absence of radiographically measurable disease, exceptions may be granted with study PI approval * Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy * Without bone marrow involvement: Absolute neutrophil count (ANC) \>= 1,000/mm\^3 With bone marrow involvement: No minimal requirement * NOTE: Growth factor is not permitted within 7 days prior to screening unless cytopenia is secondary to disease involvement. * Without bone marrow involvement: Platelets \>= 75,000/mm\^3 With bone marrow involvement: Platelets \>= 30,000/mm\^3 * NOTE: Platelet transfusions are not permitted within 7 days prior to screening unless cytopenia is secondary to disease involvement * Hemoglobin \>= 8 g/dL unless anemia is secondary to disease involvement * NOTE: Erythropoietin and/or red blood cell transfusions are not permitted within 7 days prior to screening. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (If hepatic involvement by lymphoma, or Gilbert's disease: =\< 3X ULN) * Aspartate aminotransferase (AST) =\< 2.5 x ULN (If hepatic involvement by lymphoma: AST =\< 5 x ULN) * Alanine aminotransferase (ALT) =\< 2.5 x ULN (If hepatic involvement by lymphoma: ALT =\< 5 x ULN) * Normal creatinine (Cr) level per local laboratory reference range or creatinine clearance of \>= 50mL/min per 24 hour urine test or the Cockcroft-Gault formula * If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) =\< 1.5 x ULN If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants * If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants * Left ventricular ejection fraction (LVEF) \>= 40% * Oxygen (O2) saturation \>= 92% on room air * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females of childbearing potential\* to abstain from heterosexual intercourse or use two adequate methods of birth control, including at least one method with a failure rate of \< 1% per year, during the treatment period until at least 7 days after the final dose of acalabrutinib; at least 2 months after the final dose glofitamab; at least 18 months after the dose of obinutuzumab; and at least 4 months after the last dose of tocilizumab (as applicable). Women must refrain from donating eggs during this same period Agreement by males to abstain from heterosexual intercourse or use a condom with female partners of childbearing potential or pregnant female partners during the treatment period and for at least 2 months after the last dose of glofitamab, and at least 4 months after the last dose of obinutuzumab, or tocilizumab (as applicable) to avoid exposing the embryo. Men must refrain from donating sperm during this same period * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) with no identified cause other than menopause * Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices Exclusion Criteria: * Prior treatment with a T-cell engaging bispecific antibody * Prior therapeutic intervention with any of the following: therapeutic anti-cancer antibodies within 4 weeks (i.e. rituximab); radio- or toxin-immunoconjugates within 4 weeks; all other chemotherapy or radiation therapy within 2 weeks prior to day 1 of protocol therapy * Prior exposure to a BTK inhibitor (including but not limited to ibrutinib, acalabrutinib, zanubrutinib, and pirobrutinib) for more than 180 cumulative days prior to enrollment. Patients with =\< 180 cumulative days on BTK inhibitor prior to enrollment are allowed, as long as they did not progress on treatment. * Prior chimeric antigen receptor (CAR) T cell therapy within 6 months of day 1 of protocol therapy * Prior allogeneic stem cell transplant * Autologous hematopoietic stem cell transplant within 3 months of day 1 of protocol therapy * Major surgical procedure (under general anesthesia) within 30 days of day 1 of protocol therapy. * Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug * Systemic steroid therapy for any cau
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What it tests

  • Acalabrutinib
  • Biospecimen Collection
  • Bone Marrow Biopsy
  • Computed Tomography
  • Echocardiography
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Where

1 site
City of Hope Medical Center
Duarte, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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