An open-label, treatment-option protocol of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma
The goal of this clinical research study is learn more about the safety of SGN-35 (brentuximab vedotin) in patients who participated in 2009-0851, were on placebo, and whose HL has gotten worse. Another goal of this study is to allow other patients with HL and ALCL whose disease has come back or is not getting better on another treatment, access to brentuximab vedotin.
Disease Group: Lymphoma
Treatment Agent: SGN-35
Treatment Location: Both at MD Anderson & Other Sites
Sponsor: Seattle Genetics, Inc.
Primary Objectives The primary objectives of this study are • To provide the option of treatment with brentuximab vedotin for those patients allocated to the placebo treatment arm in study SGN35-005 (2009-0851) who experience progression of Hodgkin Lymphoma (HL) • To assess the safety and tolerability of brentuximab vedotin • In the US only, to provide access to brentuximab vedotin for patients with relapsed or refractory HL, and patients with relapsed or refractory anaplastic large cell lymphoma (ALCL). Endpoints The safety endpoints are the type, incidence, severity, seriousness, and study drug relatedness of adverse events (AEs).
IRB Review and Approval Date: 02/08/2011
Recruitment Status: Closed
Projected Accrual: 380
1) Patients who met all inclusion/exclusion criteria for and
participated in the SGN35-005 clinical study, were treated with placebo
in the SGN35-005 clinical study after autologous SCT, and experienced
progression of HL based on the Revised Response Criteria for Malignant
Lymphoma as defined by protocol in study SGN35-005. OR In the United
States (US) only, patients with relapsed or refractory HL OR In the
United States (US) only, patients with relapsed or refractory systemic
ALCL who have previously received frontline chemotherapy (cytoxan,
hydroxydoxorubicin, oncovin, and prednisone CHOP or multi-agent
chemotherapy regimens with curative intent) and documented anaplastic
lymphoma kinase (ALK) status.
2) Patients who were treated with placebo in the SGN35-005 clinical study after autologous stem cell transplant (ASCT) and experienced progression of HL based on the Revised Response Criteria for Malignant Lymphoma (Cheson 2007) as defined by protocol in study SGN35-005.
3) Age greater than or equal to 18 years. Patients of age greater than or equal to 6 years may be enrolled at US sites. Permission from the Sponsor must be granted prior to enrollment for ages 6 years to <12 years.
4) An Eastern Cooperative Oncology Group (ECOG) performance status of </= 2.
5) Patients must have completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of SGN-35, unless underlying disease is progressing on therapy.
6) Females of childbearing potential must have a negative serum or urine Beta-hCG pregnancy test result within 7 days prior to the first dose of brentuximab vedotin. Females of non-childbearing potential are those who are postmenopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy.
7) Both females of childbearing potential 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.
8) The following baseline laboratory values are required: absolute neutrophil count (ANC) >/= 1000/microL, platelets >/= 50,000/microL, total bilirubin </= 1.5 x upper limit of normal (ULN) or </= 3 x ULN for patients with Gilbert’s disease, serum creatinine </= 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 2.5 x ULN.
9) Patients or their legally authorized representative must provide written informed consent.
1) Any Grade 3 viral, bacterial, or fungal infection requiring treatment
within 1 week prior to the first study dose.
2) Patients with >/= Grade 2 peripheral neuropathy.
3) 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: nonmelanoma 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 PAP smear.)
4) Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy (PML).
5) Current therapy with other systemic anti-neoplastic or investigational agents.
6) Women who are pregnant or lactating.
7) Patients with a known hypersensitivity to any excipient contained in the drug formulation.
8) Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
9) Patients in Eastern and Western Europe who are eligible for participation in other clinical studies of brentuximab vedotin at their institution.
10) In the US only, patients who are eligible for participation in other Seattle Genetics sponsored clinical studies of brentuximab vedotin.
11) In the US only, patients with prior allogeneic SCT if < 100 days from prior allogeneic SCT, or have acute or chronic graft-versus-host disease (GvHD) or are receiving immunosuppressive therapy as treatment for or prophylaxis against GvHD.