A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Seattle Genetics, Inc.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00866047
First received: March 19, 2009
Last updated: October 8, 2012
Last verified: October 2012
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Results First Received: September 15, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin |
| Intervention: |
Drug: brentuximab vedotin |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Enrollment period: Jun 2009 - May 2010 |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Brentuximab Vedotin | Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion |
Participant Flow for 2 periods
Period 1: Treatment Period
| Brentuximab Vedotin | |
|---|---|
| STARTED | 58 |
| COMPLETED | 3 [1] |
| NOT COMPLETED | 55 |
| Progressive disease | 13 |
| Adverse Event | 14 |
| Physician Decision | 14 |
| Withdrawal by Subject | 5 |
| Continuing on treatment | 9 |
| [1] | Number who completed 16 cycles of treatment |
|---|
Period 2: Follow-up Period
| Brentuximab Vedotin | |
|---|---|
| STARTED | 43 [1] |
| COMPLETED | 12 [2] |
| NOT COMPLETED | 31 |
| Continuing in follow-up | 31 |
| [1] | All participants were to be followed after treatment |
|---|---|
| [2] | Completed survival follow-up due to death |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Brentuximab Vedotin | Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion |
Baseline Measures
| Brentuximab Vedotin | |
|---|---|
|
Number of Participants
[units: participants] |
58 |
|
Age, Customized
[units: years] Median ( Full Range ) |
52.0
( 14 to 76 ) |
|
Gender
[units: participants] |
|
| Female | 25 |
| Male | 33 |
|
Race (NIH/OMB)
[units: participants] |
|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 48 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
|
Eastern Cooperative Oncology Group Performance Status
[1] [units: participants] |
|
| 0 | 19 |
| 1 | 38 |
| 2 | 1 |
| 3-5 | 0 |
|
ALK Status
[2] [units: participants] |
|
| Positive | 16 |
| Negative | 42 |
| [1] | 0 = Normal activity
|
|---|---|
| [2] | Immunophenotype status with respect to anaplastic lymphoma kinase (ALK) protein |
Outcome Measures
| 1. Primary: | Objective Response Rate by Independent Review Group [ Time Frame: up to 12 months ] |
| 2. Secondary: | Complete Remission Rate by Independent Review Group [ Time Frame: up to 12 months ] |
| 3. Secondary: | Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: up to 17.5 months ] |
| 4. Secondary: | Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis [ Time Frame: up to 17.5 months ] |
| 5. Secondary: | Progression-free Survival by Kaplan-Meier Analysis [ Time Frame: up to 17.5 months ] |
| 6. Secondary: | Overall Survival [ Time Frame: up to 17.5 months ] |
| 7. Secondary: | Adverse Events by Severity, Seriousness, and Relationship to Treatment [ Time Frame: up to 12 months ] |
| 8. Secondary: | Hematology Laboratory Abnormalities >/= Grade 3 [ Time Frame: up to 12 months ] |
| 9. Secondary: | Chemistry Laboratory Abnormalities >/= Grade 3 [ Time Frame: up to 12 months ] |
| 10. Secondary: | Area Under the Curve [ Time Frame: 3 weeks ] |
| 11. Secondary: | Maximum Serum Concentration [ Time Frame: 3 weeks ] |
| 12. Secondary: | Time of Maximum Serum Concentration [ Time Frame: 3 weeks ] |
| 13. Other Pre-specified: | B Symptom Resolution [ Time Frame: up to 12 months ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Maximum duration of follow-up was 17.5 months; 9 participants were continuing on treatment and 31 participants remained in survival follow-up at the time of the efficacy analyses. |
Results Point of Contact:
Name/Title: Chief Medical Officer
Organization: Seattle Genetics, Inc.
phone: 855-473-2436
e-mail: medinfo@seagen.com
Organization: Seattle Genetics, Inc.
phone: 855-473-2436
e-mail: medinfo@seagen.com
No publications provided
| Responsible Party: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00866047 History of Changes |
| Other Study ID Numbers: | SG035-0004, 2008-006035-12 |
| Study First Received: | March 19, 2009 |
| Results First Received: | September 15, 2011 |
| Last Updated: | October 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |