Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Condition: Adult T-Cell Leukemia/Lymphoma; Anaplastic Large Cell Lymphoma, ALK-Negative; Anaplastic Large Cell Lymphoma, ALK-Positive; Angioimmunoblastic T-Cell Lymphoma; Ann Arbor Stage II Noncutaneous Anaplastic Large Cell Lymphoma; Ann Arbor Stage III Noncutaneous Anaplastic Large Cell Lymphoma; Ann Arbor Stage IV Noncutaneous Anaplastic Large Cell Lymphoma; Enteropathy-Associated T-Cell Lymphoma; Hepatosplenic T-Cell Lymphoma; Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Peripheral T-Cell Lymphoma, Not Otherwise Specified
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell; Lymphoma, Large-Cell, Anaplastic; Enteropathy-Associated T-Cell Lymphoma; Immunoblastic Lymphadenopathy
Intervention: Brentuximab Vedotin; Cyclophosphamide; Doxorubicin; Doxorubicin Hydrochloride; Etoposide; Etoposide Phosphate; Laboratory Biomarker Analysis; Prednisone
Intervention description: Given IV; Given IV; Given IV; Given IV; Given IV; Given IV; Correlative studies; Given PO
Intervention MeSH terms: Prednisone; Cortisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Etoposide; Etoposide phosphate; Daunorubicin; Brentuximab Vedotin; Podophyllotoxin; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Immunoconjugates
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well brentuximab vedotin and combination
      chemotherapy work in treating patients with CD30-positive peripheral T-cell lymphoma.
      Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called
      vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers
      vedotin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin,
      etoposide, and prednisone work in different ways to stop the growth of cancer cells, either
      by killing the cells, by stopping them from dividing, or by stopping them from spreading.
      Giving brentuximab vedotin and combination chemotherapy may work better in treating patients
      with CD30-positive peripheral T-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented informed consent of participant and/or legally authorized representative

          -  Agreement to allow the use of archival tissue from diagnostic tumor biopsies will be
             retrieved and submitted post-enrollment

               -  If unavailable, exceptions may be granted with study principal investigator (PI)
                  approval.

          -  Eastern Cooperative Oncology Group (ECOG) status =< 2

          -  Histologically confirmed mature peripheral T-cell or natural killer (NK)-cell lymphoma
             per World Health Organization (WHO) classification, including:

               -  Anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL)
                  with international protein index (IPI) of 2 or higher (must have bulky [defined
                  as mass >= 10 cm] stage II, or stage III-IV disease)

               -  ALK-negative ALCL

                    -  NOTE: Per amendment dated 05-10-19, ALCL will no longer be eligible except
                       for Canada.

               -  PTCL-not otherwise specified (NOS)

               -  Angioimmunoblastic T-cell lymphoma (AITL)

               -  Adult T-cell lymphoma/leukemia (ATLL)

               -  Enteropathy-associated T-cell lymphoma (EATL)

               -  Hepatosplenic T-cell lymphoma

          -  CD30-positivity (e.g. at least 1%) by immunohistochemistry confirmed by
             hematopathology review at the participating institution

          -  Measurable disease of at least 1.5 cm on computed tomography (CT) or positron emission
             tomography (PET)-CT scan

          -  Absolute neutrophil count (ANC) >= 1,000/mm^3

               -  Exception: unless documented bone marrow involvement by lymphoma

          -  Platelets >= 50,000/mm^3

               -  Exception: unless documented bone marrow involvement by lymphoma

          -  Total serum bilirubin =< 1.5 x upper limit of normal (ULN) OR if hepatic involvement
             by lymphoma: =< 3 x ULN for Gilbert's disease or documented hepatic involvement by
             lymphoma

          -  Aspartate aminotransferase (AST) =< 2 x ULN OR if hepatic involvement by lymphoma: AST
             =< 5 x ULN

          -  Alanine aminotransferase (ALT) =< 2 x ULN OR if hepatic involvement by lymphoma: ALT
             =< 5 x ULN

          -  Creatinine clearance of >= 60 mL/min per the Cockcroft-Gault formula

          -  Left ventricular ejection fraction (LVEF) >= 45%

          -  Women of childbearing potential (WOCBP): negative urine or serum pregnancy test; if
             the urine test is positive or cannot be confirmed as negative, a serum pregnancy test
             will be required

          -  Agreement by WOCBP and males of childbearing potential to use an effective method of
             birth control or abstain from heterosexual activity for the course of the study
             through at least 6 months after the last dose of protocol therapy; childbearing
             potential defined as not being surgically sterilized (men and women) or have not been
             free from menses for > 1 year (women only)

        Exclusion Criteria:

          -  Prior treatment of PTCL with systemic anti-lymphoma therapies, investigational agents,
             radiation

               -  Exception: May have received 1 cycle of CHOP-like therapy (e.g. CHOP, CHOEP,
                  EPOCH) or 1 cycle of CHP-BV; these participants must initiate day 1 cycle 1 of
                  study therapy (CHEP-BV) no less than 19 days from prior CHOP-like or CHP-BV
                  therapy; Patients who received 1 cycle of CHOP-like or 1 cycle of CHP-BV therapy
                  prior to initiating induction with CHEP-BV are allowed to receive only 5 cycles
                  of CHEP-BV instead of 6 cycles, per investigator's discretion

          -  History of another primary invasive cancer, hematologic malignancy, or myelodysplastic
             syndrome that has not been in remission for at least 3 years.

               -  Exceptions: Non-melanoma skin cancer and in situ cervical cancer

          -  Symptomatic cardiac disease (including symptomatic ventricular dysfunction,
             symptomatic coronary artery disease, and symptomatic arrhythmias), cerebrovascular
             event/stroke or myocardial infarction within the past 6 months

          -  Central nervous system involvement by lymphoma, including leptomeningeal involvement

          -  History of progressive multifocal leukoencephalopathy (PML)

          -  Active >= grade 3 viral, bacterial, or fungal infection within 2 weeks prior to day 1
             of protocol therapy

          -  Any known human immunodeficiency virus (HIV) infection, hepatitis B surface
             antigen-positive status, or known or suspected active hepatitis C infection

          -  Baseline peripheral neuropathy >= grade 2 or patients with the demyelinating form of
             Charcot-Marie-Tooth syndrome

          -  Known severe hypersensitivity to any study related agent excipient(s)

          -  Females only: pregnant or breastfeeding

          -  Any other condition that would, in the investigator's judgement, contraindicate the
             patient's participation in the clinical study

          -  Prospective participants who, in the opinion of the investigator, may not be able to
             comply with all study procedures (including compliance issues related to
             feasibility/logistics)