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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 55

Inclusion Criteria

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

1. Patients with relapsed or refractory systemic ALCL who have previously received front-line chemotherapy (CHOP or multi-agent anthracycline- or anthracenedione-based chemotherapy).
2. Documented anaplastic lymphoma kinase (ALK) status.
3. Histologically-confirmed CD30-positive disease by central review; 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. See section 7.4 of the protocool for details.
4. Age greater than or equal to 18 years.
- Patients of age greater than or equal to 12 years may be enrolled at US and Canadian sites.
5. Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT, as assessed by the site radiologist.
6. At least ONE of the following as evidence of relapsed or refractory systemic ALCL:
a) Histologically-documented CD30-positive systemic ALCL from a biopsy obtained at least 4 weeks subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents.
b) Interval tumor growth documented between two successive CT evaluations with the second evaluation occurring at least 4 weeks after delivery of any radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents.
c) FDG-avidity by PET in a new tumor mass on CT that is unlikely to have an alternative explanation.
d) Recurrent FDG-avidity by PET in a previously identified FDG-avid tumor mass on CT that had become negative.
e) FDG-avid tumor mass by PET in conjunction with systemic ALCL related symptoms (e.g., pruritus, B symptoms (fever, night sweats, or weight loss >10%)), after infectious causes have been excluded.
7. Received any previous ASCT at least 12 weeks (3 months) prior to the first study dose and/or completed any previous treatment with radiation, chemotherapy, biologics and/or other investigational agents at least 4 weeks prior to the first dose of SGN-35. Patients must have completed any prior immunotherapy (e.g. monoclonal antibody) or radioisotopic therapy at least 12 weeks prior to the first dose of SGN-35 in the absence of clear disease progression.
8. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. 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.
10. 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.
11. 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.
12. 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 Adu

Exclusion Criteria

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

1. Previous treatment with SGN-35.
2. Previously received an allogeneic transplant.
3. Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
4. Congestive heart failure, Class III or IV, by the NYHA criteria.
5. 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.)
6. Known cerebral/meningeal disease.
7. Any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of SGN-35.
8. Current therapy with other systemic anti-neoplastic or investigational agents.
9. 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.
10. Women who are pregnant or lactating.
11. Patients with a known hypersensitivity to any excipient contained in the drug formulation.
12. 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

Secondary Outcome Measures

Name	Time	Method

Updated 8/8/2022

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

Seattle Genetics, Inc.

Updated 8/4/2015