Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma

Not Recruiting

Trial ID: NCT01476410


This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine together may kill more cancer cells.

Official Title

A Phase II Trial of Sequential SGN-35 Therapy With Adriamycin, Vinblastine, and Dacarbazine (S-AVD) for Older Patients With Untreated Hodgkin Lymphoma

Stanford Investigator(s)

Ranjana Advani
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology


Inclusion Criteria:

   - Voluntary written informed consent before performance of any study-related procedure
   not part of normal medical care, with the understanding that consent may be withdrawn
   by the subject at any time without prejudice to future medical care

   - Previously untreated classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed
   cellularity, lymphocyte depleted, lymphocyte-rich, and not otherwise specified [NOS]);
   nodular lymphocyte predominant Hodgkin lymphoma is not eligible

   - Stage II, III, and IV disease by Ann Arbor classification

   - Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

   - Patients must have bi-dimensional measurable disease documented in the lymphoma
   baseline tumor assessment form within 30 days prior to registration (at least 1.5 cm);
   patients with non-measurable disease in addition to measurable disease must have been
   assessed within 60 days prior to registration

   - Patients must have a bone marrow biopsy (bilateral preferred, unilateral acceptable)
   within 60 days prior to registration

   - Patients must have a multi gated acquisition scan (MUGA) or echocardiogram within 60
   days prior to study registration and the ejection fraction must be >= 45%

   - Absolute neutrophil count (ANC) > 1000/mm^3

   - Platelet count > 75,000/mm^3

   - Creatinine < 2.5 mg/dl

   - Bilirubin < 3.0 mg/dl

   - Patients with documented marrow involvement by lymphoma at the time of registration
   are not required to meet the above hematologic parameters

   - Patients must not have received prior chemotherapy or radiation therapy for the
   treatment of Hodgkin lymphoma

   - Both females and males who have partners of childbearing potential must agree to use
   an effective contraceptive method during the study and for 30 days following the last
   dose of study drug

   - Patients must sign the informed consent form before registration

Exclusion Criteria:

   - Previous treatment with brentuximab vedotin or any other prior anti-CD30-based
   antibody therapy

   - History of another primary malignancy that has not been in remission for at least 3
   years; (the following are exempt from the 3-year limit: early stage [stage I or II]
   breast cancer treated with surgery and radiation +/- hormones [without adjuvant
   chemotherapy], non-melanoma skin cancer, fully excised melanoma in situ [stage 0],
   curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy
   or a squamous intraepithelial lesion on Papanicolaou test [PAP smear])

   - Known cerebral/meningeal disease

   - Any active systemic viral, bacterial, or fungal infection requiring treatment with
   antimicrobial therapy within 1 week prior to first dose

   - Patients with hepatitis B surface antigen (HBsAg) positive hepatitis B virus (HBV)
   infection; patients with prior history of hepatitis B infection, but immune, with only
   Immunoglobulin G (IgG) hepatitis core antibody + (HBcAb +) must receive anti-viral
   prophylaxis (e.g., lamivudine 100mg orally [po] daily) for at least 1 week prior to
   cycle 1 and throughout induction and continuation therapy and for at least 6 months
   after the last brentuximab vedotin dose; in addition, consultation with a hepatologist
   is recommended

   - Patients with a known hypersensitivity to any excipient contained in the drug

   - Patients with dementia or an altered mental state that would preclude the
   understanding and rendering of informed consent


drug: brentuximab vedotin

drug: doxorubicin hydrochloride

drug: vinblastine

drug: dacarbazine

procedure: quality-of-life assessment

genetic: DNA analysis

genetic: RNA analysis

radiation: fludeoxyglucose F 18

procedure: positron emission tomography

other: laboratory biomarker analysis

other: immunohistochemistry staining method

genetic: polymorphism analysis

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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