Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
Primary Purpose
Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-35
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Antigens,CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically confirmed CD30-positive hematologic malignancy.
- Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
- Patients must have measurable disease of at least 10mm as documented by radiographic technique.
- Must be at least 18 years of age.
Exclusion Criteria:
- Patients with current diagnosis of pcALCL (systemic ALCL eligible).
- Patients with history of allogeneic stem cell transplant.
- Patients who have had previous treatment with any anti-CD30 antibody.
Sites / Locations
- University of Alabama at Birmingham
- Washington University
- Weill Cornell Medical College
- University of Texas/MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events and laboratory abnormalities
Secondary Outcome Measures
PK profile
Immunogenicity (anti-SGN-35 antibodies)
Anti-tumor activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00430846
Brief Title
Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
Official Title
A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic
Keywords
Antigens,CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Hematologic Diseases, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SGN-35
Other Intervention Name(s)
brentuximab vedotin
Intervention Description
Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg
Primary Outcome Measure Information:
Title
Incidence of adverse events and laboratory abnormalities
Time Frame
1 month after last dose
Secondary Outcome Measure Information:
Title
PK profile
Time Frame
2 months after last dose
Title
Immunogenicity (anti-SGN-35 antibodies)
Time Frame
1 month after last dose
Title
Anti-tumor activity
Time Frame
1 month after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically confirmed CD30-positive hematologic malignancy.
Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
Patients must have measurable disease of at least 10mm as documented by radiographic technique.
Must be at least 18 years of age.
Exclusion Criteria:
Patients with current diagnosis of pcALCL (systemic ALCL eligible).
Patients with history of allogeneic stem cell transplant.
Patients who have had previous treatment with any anti-CD30 antibody.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Forero, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anas Younes, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Bartlett, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Leonard, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana Kennedy, PharmD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21047225
Citation
Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010 Nov 4;363(19):1812-21. doi: 10.1056/NEJMoa1002965.
Results Reference
result
PubMed Identifier
32596842
Citation
Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Dec;60(12):1585-1597. doi: 10.1002/jcph.1682. Epub 2020 Jun 28.
Results Reference
derived
Links:
URL
http://ALCL.com
Description
Related Info
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Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
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