Sandra Horning
A Pivotal Open-Label Trial of SGN-35 for Hodgkin Lymphoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of SGN-35 as a single agent in patients with relapsed or refractory Hodgkin lymphoma.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: SGN-35
Phase:
Phase 2Eligibility
Ages Eligible for Study:
12 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant
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
3. Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm as documented by spiral CT
4. At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.
Key Exclusion Criteria:
1. Previous treatment with SGN-35
2. Previously received an allogeneic transplant
3. Congestive heart failure, Class III or IV, by the New York Heart Association criteria
4. History of another primary malignancy that has not been in remission for at least 3 years
5. Known cerebral/meningeal disease
Additional Study Details
Official Title:
A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)Anticipated start date:
4/1/2009Lead Sponsor:
Seattle Genetics, Inc.Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Best clinical response [ Time Frame: Every 2 to 3 months ]
Secondary Outcomes:
- Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
- PK profile [ Time Frame: Every 2 or 3 weeks ]
- Duration of response, progression-free survival, overall survival [ Time Frame: Every 3 months until death or study closure ]
Total Number to be Enrolled:
100Total Number to be Enrolled at Stanford:
2More Information
Secondary ID(s):
- LYMHD0005
- NCT00848926
- SG035-0003
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
5/21/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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