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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
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 1, 2007
Last Updated
December 17, 2014
Sponsor
Seagen Inc.
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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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