A pivotal study of SGN-35 in treatment of patients with relapsed or refractory Hodgkin Lymphoma (HL)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 102

Inclusion Criteria

To be eligible for this study, patients must meet all of the following inclusion criteria :

1. Patients with relapsed or refractory HL who have previously received ASCT. Patients must have received prior ASCT at least 12 weeks (3 months) before the first dose of SGN-35 and completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents at least 4 weeks prior to the first dose of SGN-35.
2. Histologically-confirmed CD30-positive disease; tissue from the most recent post-diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block. If such tissue is not available, a fresh biopsy must be obtained.
3. Age greater than or equal to 18 years.
4. Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT.
5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. The following required baseline laboratory data: absolute neutrophil count (ANC) =1000/µL, platelets =50,000/µL, bilirubin =1.5X upper limit of normal (ULN) or =3X ULN for patients with Gilbert’s disease, serum creatinine =1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5X ULN.
7. Females of childbearing potential must have a negative serum or urine ß-hCG pregnancy test result within 7 days prior to the first dose of SGN-35. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
8. 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.
9. Patients or their legally authorized representative must provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

If a patient is positive for any of the following exclusion criteria, the patient will not be eligible for this study:

1. Previous treatment with SGN-35.
2. Previously received an allogeneic transplant.
3. Congestive heart failure, Class III or IV, by the NYHA criteria.
4. 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, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
5. Known cerebral/meningeal disease.
6. Any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of SGN-35.
7. Current therapy with other systemic anti-neoplastic or investigational agents.
8. Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of SGN-35.
9. Women who are pregnant or lactating.
10. Patients with a known hypersensitivity to any excipient contained in the drug formulation.
11. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to determine the antitumor efficacy of single-agent SGN-35 (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory Hodgkin lymphoma following autologous stem cell transplant;Secondary Objective: The secondary objectives of this study are the following:<br>• To assess duration of tumor control, including duration of response and progression-free survival (PFS)<br>• To assess survival<br>• To assess the safety and tolerability of SGN-35<br>• To assess the pharmacokinetics of SGN-35<br><br>Furthermore, additional objectives are the following:<br>• To assess disease-related symptoms<br>• To explore the correlation of potential biomarkers with clinical outcomes;Primary end point(s): The primary endpoint of this study is the overall objective response rate (ORR) per an independent review facility (IRF).

Secondary Outcome Measures

Name	Time	Method

A pivotal study of SGN-35 in treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL)

Seattle Genetics, Inc.

Updated 3/19/2012