Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma, Large Cell Transformation of Mycosis Fungoides, and Lymphomatoid Papulosis
1 other identifier
interventional
40
1 country
13
Brief Summary
This multi-center, phase II study will be conducted to define the toxicity profile and antitumor activity of SGN-30 in patients with pcALCL and other closely related lymphoproliferative disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2004
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 10, 2004
CompletedFirst Posted
Study publicly available on registry
December 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedDecember 18, 2014
December 1, 2014
2.4 years
December 10, 2004
December 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To determine the objective response rate in patients with pcALCL, T-MF, and LyP
To determine the duration of response in patients treated with SGN-30
To investigate the toxicity profile of SGN-30
Secondary Outcomes (2)
To provide preliminary estimates of disease-free and overall survival rates in pcALCL and T-MF patients treated with SGN-30
To determine the immunogenicity of SGN-30
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have a definite diagnosis.
- Patients must be histologically confirmed CD30 positive within 3 months of enrollment
- Patients with pcALCL must have target lesions present for at least 1 month without spontaneous regression
- pcALCL patients must have failed treatment with local radiation therapy, or failed systemic therapy of a single agent
- Patients must be considered an eligible candidate for systemic therapy as determined by the investigator
- All patients must have a three week wash-out from previous treatments, unless in the opinion of the investigator it is not in the best interest of the patient, at which point the individual case must be discussed with the medical monitor prior to enrollment.
- Patients must have an ECOG performance status of \< 2 (Appendix B) and a life expectancy \> six months.
- Patients must be at least 18 years of age.
- Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
- Females of childbearing potential must have a negative HCG pregnancy test result within three days of enrollment. All patients must agree to use an effective contraceptive method during the course of the study.
- Patients must give written informed consent.
- Required baseline laboratory data: Absolute neutrophil count greater than or equal to to 1,000/mm3, Platelet count greater than or equal to 75,000/mm3, Serum bilirubin less than or equal to 1.5 times ULN, Serum creatinine less than or equal to 1.5 times ULN, BUN less than or equal to 1.5 times ULN, SGOT less than or equal to 2.5 ULN, SGPT less than or equal to 2.5 ULN
- Patients with Sezary syndrome, or any type of lymphoproliferative disease other than pcALCL, T-MF or LyP
- Patients with systemic ALCL or extracutaneous involvement of cutaneous ALCL
- Patients with known active systemic viral, bacterial, or fungal infection
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (13)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California at Los Angeles
Los Angeles, California, 90095, United States
Stanford University
Stanford, California, 94305, United States
Yale
New Haven, Connecticut, 06520, United States
Northwestern Universtiy
Chicago, Illinois, 60611, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Johns Hopkins
Baltimore, Maryland, 21827, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Memorial Sloan-Kettering
New York, New York, 10021, United States
Cleveland University
Cleveland, Ohio, 44106, United States
Kaiser Permanente - Oncology Research
Portland, Oregon, 97227, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Duvic M, Reddy SA, Pinter-Brown L, Korman NJ, Zic J, Kennedy DA, Lorenz J, Sievers EL, Kim YH. A phase II study of SGN-30 in cutaneous anaplastic large cell lymphoma and related lymphoproliferative disorders. Clin Cancer Res. 2009 Oct 1;15(19):6217-24. doi: 10.1158/1078-0432.CCR-09-0162. Epub 2009 Sep 29.
PMID: 19789316RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 10, 2004
First Posted
December 10, 2004
Study Start
September 1, 2004
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
December 18, 2014
Record last verified: 2014-12