a study of brentuximab vedotin and chp in frontline treatment of ptcl with less than 10% cd30 expression

Conditions: Peripheral T-cell Lymphoma

Summary: this clinical trial will study brentuximab vedotin with chp to find out if the drugs work for people who have certain types of peripheral t-cell lymphoma (ptcl). it will also find out what side effects occur when brentuximab vedotin and chp are used together. a side effect is anything the drugs do besides treating cancer. chp is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). chp is approved by the fda to treat certain types of ptcl.


Eligibility criteria:
inclusion criteria * newly diagnosed ptcl, excluding systemic anaplastic large cell lymphoma (salcl), per the revised european-american lymphoma world health organization (who) 2016 classification * the following non-salcl ptcl subtypes are eligible: * ptcl - not otherwise specified (ptcl-nos) * angioimmunoblastic t-cell lymphoma (aitl) * adult t-cell leukemia/lymphoma (atll; acute and lymphoma types only, must be positive for human t cell leukemia virus 1) * enteropathy-associated t-cell lymphoma (eatl) * hepatosplenic t-cell lymphoma * monomorphic epitheliotropic intestinal t-cell lymphoma (meitcl) * indolent t-cell lymphoproliferative disorder (t-lpd) of the gastrointestinal (gi) tract * follicular t-cell lymphoma * nodal peripheral t-cell lymphoma with t-follicular helper (tfh) phenotype * cd30 expression \<10% by local assessment in tumor containing lymph node or other extranodal soft tissue biopsy * fluorodeoxyglucose (fdg)-avid disease by pet and measurable disease of at least 1.5 cm by ct, as assessed by the site radiologist * an eastern cooperative oncology group (ecog) performance status less than or equal to 2 exclusion criteria * current diagnosis of any of the following: * salcl * primary cutaneous t-cell lymphoproliferative disorders and lymphomas * mycosis fungoides (mf), including transformed mf * history of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year os ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage i uterine cancer. * history of progressive multifocal leukoencephalopathy (pml). * cerebral/meningeal disease related to the underlying malignancy. * prior treatment with brentuximab vedotin or doxorubicin. * baseline peripheral neuropathy grade 2 or higher (per the nci ctcae, version 4.03) or subjects with the demyelinating form of charcot-marie-tooth syndrome. * left ventricular ejection fraction less than 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months, or previous treatment with complete cumulative dose of \>300 mg/m2 of doxorubicin. * any uncontrolled grade 3 or higher (per the national cancer institute's common terminology criteria for adverse events, nci ctcae version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. routine antimicrobial prophylaxis is permitted.

Keywords: cd30-positive cd30-negative seattle genetics