Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma (NCT04189757) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Acalabrutinib for the Treatment of Ibrutinib-Intolerant Mantle Cell Lymphoma
United States9 participantsStarted 2020-08-07
Plain-language summary
This phase II trial studies how well acalabrutinib works in treating patients with mantle cell lymphoma that cannot tolerate ibrutinib. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Confirmed diagnosis of mantle cell lymphoma with CD20 positivity and chromosome translocation t(11;14), (q13;q32) and/or overexpress cyclin D1 in tissue biopsy
* Include patients who require treatment (versus watch/wait)
* Prior treatment with ibrutinib discontinued for reasons other than progression
* Ibrutinib intolerance is defined as unacceptable toxicity where, in the opinion of the investigator, treatment should be discontinued in spite of optimal supportive care as a result of one of the following:
* 2 or more grade \>= 2 non-hematological toxicities; OR
* 1 or more grade 3 \>= 3 non-hematological toxicity; OR
* 1 or more grade 3 neutropenia with infection or fever; OR,
* Grade 4 hematologic toxicity which persists to the point that the investigator chose to stop therapy due to toxicity NOT progression
* Toxicity must have resolved to =\< grade 1 prior to acalabrutinib dosing
* Understand and voluntarily sign an Institutional Review Board (IRB)-approved informed consent form
* Bi-dimensional measurable disease using the Cheson criteria (measurable disease by positron emission tomography \[PET\]-computed tomography \[CT\] scan defined as at least 1 lesion that measures \>= 1.5 cm in single dimension). Gastrointestinal, bone marrow or spleen only patients are allowable
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
* Absolute neutrophil count (ANC) \> 1,000/mm\^3
* Patients who have bone marrow infiltra…