Michael Link
A Phase 2 Open Label Trial of SGN-35 for Systemic Anaplastic Large Cell Lymphoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of SGN-35 as a single agent in patients with relapsed or refractory ALCL.
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:
- Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
- Documented anaplastic lymphoma kinase (ALK) status.
- 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.
- Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT.
- Received any previous ASCT at least 12 weeks (3 months) prior.
- 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:
- Previous treatment with SGN-35.
- Previously received an allogeneic transplant.
- Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
- Known cerebral/meningeal disease.
Additional Study Details
Official Title:
A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)Anticipated start date:
7/31/2009Lead 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 ] [ Designated as safety issue: No ]
Secondary Outcomes:
- Duration of response, progression-free survival, overall survival. [ Time Frame: Every 3 months until death or study closure ] [ Designated as safety issue: No ]
- Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
- PK profile [ Time Frame: Every 2 or 3 weeks ] [ Designated as safety issue: No ]
Total Number to be Enrolled:
55Total Number to be Enrolled at Stanford:
3More Information
Secondary ID(s):
- NCT00866047
- PEDSALCL0002
- SG035-0004
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:
8/18/2009PLEASE 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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