| March 19, 2009 |
| September 24, 2009 |
| March 2009 |
| October 2010 (final data collection date for primary outcome measure) |
| Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00866047 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- 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 ]
|
| |
| A Phase 2 Open Label Trial of SGN-35 for Systemic Anaplastic Large Cell Lymphoma |
| A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL) |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Anaplastic
|
| Drug: SGN-35 |
| Experimental: SGN-35 every 21 days by IV infusion (1.8 mg/kg) |
| |
| |
| Recruiting |
| 55 |
|
| October 2010 (final data collection date for primary outcome measure) |
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.
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.
|
| Both |
| 12 Years and older |
| No |
|
|
| United States, Belgium, Canada, France, Italy |
| |
| NCT00866047 |
| Dana Kennedy, Pharm D, Seattle Genetics, Inc. |
| SG035-0004 |
| Seattle Genetics, Inc. |
|
| Study Director: |
Dana Kennedy, PharmD |
Seattle Genetics, Inc. |
|
|
| Seattle Genetics, Inc. |
| September 2009 |
