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SEGE 2412   |   13-179
A randomized, double-blind, placebo-controlled, phase 3 study of brentuximab vedotin and CHP (A + CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas

Disease(s)
Lymphoma
Lymphoma, Non - Hodgkin
Hospital(s)
Main Campus
Phase(s)
Phase 3
Stage(s)
Type(s)
Therapeutic
Drug(s)
brentuximab vedotin and CHP
CHOP

Contact Information
Cancer Answer Line

866.223.8100

8:00 am - 4:30 pm, Monday - Friday


Description
Primary
  1. To compare the progression-free survival (PFS) as determined by an independent review facility (IRF) between the 2 treatment arms
Secondary
  1. To compare the PFS per IRF between the 2 treatment arms for patients with systemic anaplastic large cell lymphoma (sALCL)
  2. To compare the complete remission (CR) rate per IRF following the completion of study treatment between the 2 treatment arms
  3. To compare overall survival (OS) between the 2 treatment arms
  4. To evaluate the safety and tolerability of the 2 treatment arms
Additional
  1. To evaluate medical resource utilization (MRU) and calculate utility values
  2. To characterize the incidence of antitherapeutic antibodies (ATA) to brentuximab vedotin

Inclusion Criteria
  1. Patients with newly diagnosed, CD30-positive mature T-cell lymphomas per the Revised European- American Lymphoma World Health Organization (WHO) 2008 classification by local assessment. Eligible histologies are limited to the following:
    1. ALK-positive sALCL with an International Prognostic Index (IPI) score greater than or equal to 2
    2. ALK-negative sALCL
    3. Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
    4. Angioimmunoblastic T-cell lymphoma (AITL)
    5. Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human Tcell leukemia virus 1)
    6. Enteropathy-associated T-cell lymphoma (EATL)
    7. Hepatosplenic T-cell lymphoma
  2. Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist.
  3. Age greater than or equal to 18 years.
  4. An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
  5. The following required baseline laboratory data:
    1. bilirubin ≤ 1.5X upper limit of normal (ULN) or ≤ 3X ULN for patients with Gilberts disease or documented hepatic involvement with lymphoma
    2. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3X ULN or ≤ 5X ULN for patients with document hepatic involvement with lymphoma
    3. serum creatinine ≤ 2X ULN
    4. absolute neutrophil count (ANC) ≥ 1000 mL (unless documented bone marrow involvement with lymphoma)
    5. platelet count ≥ 50,000/mL (unless documented bone marrow involvement with lymphoma).
  6. Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (B-hCG) pregnancy test result within 7 days prior to the first dose of study treatment and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
  7. Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of study drug.
  8. Patients or their legally authorized representative must provide written informed consent.

Exclusion Criteria
  1. History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years.
  2. Current diagnosis of any of the following:
    1. Primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas. Cutaneous ALCL with extracutaneous tumor spread beyond locoregional lymph nodes is eligible (previous single agent treatment to address cutaneous and locoregional disease is permissible).
    2. Mycosis fungoides (MF), including transformed MF
  3. History of progressive multifocal leukoencephalopathy (PML).
  4. Cerebral/meningeal disease related to the underlying malignancy.
  5. Prior treatment with brentuximab vedotin.
  6. Baseline peripheral neuropathy ≥ Grade 2 (per the NCI CTCAE, Version 4.03).
  7. 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.
  8. Any active Grade 3 (per the NCI CTCAE, Version 4.03) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment; any known human immunodeficiency virus (HIV) infection, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
  9. Current therapy with other systemic anti-neoplastic or investigational agents.
  10. Females who are pregnant or breastfeeding.
  11. Patients with a known hypersensitivity to any excipient contained in the drug formulation.
  12. Patients with known urinary outflow obstruction.

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