Trial Search Results

A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Seagen Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: brentuximab vedotin
  • Drug: cyclophosphamide
  • Drug: doxorubicin
  • Drug: prednisone

Phase:

Phase 2

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Daniel Heck
650-723-0530
Recruiting