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Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Primary Purpose

Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Anemia, Refractory, With Excess of Blasts

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
brentuximab vedotin
brentuximab vedotin
brentuximab vedotin
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoid Leukemia focused on measuring Acute Lymphoid Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia, Solid Tumors, Anemia, Refractory, with Excess of Blasts, Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Immunotherapy, Monomethyl Auristatin E

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
  • Have failed, refused, or have been deemed ineligible for standard therapy
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70

Exclusion Criteria:

  • Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
  • History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
  • Evidence of active cerebral/meningeal disease

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope
  • PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
  • Rocky Mountain Cancer Centers - Aurora
  • Mayo Clinic Cancer Center
  • Ocala Oncology Center
  • Indiana University Simon Cancer Center
  • Dana-Farber Cancer Institute
  • Minnesota Oncology Hematology P.A.
  • New York Oncology Hematology, P.C.
  • University Hospitals Case Medical Center
  • Willamette Valley Cancer and Research / USOR
  • Northwest Cancer Specialists, P.C.
  • St. Francis Hospital
  • Texas Oncology - Bedford
  • Texas Oncology - Medical City Dallas
  • Texas Oncology - Dallas Presbyterian
  • Texas Oncology Denton South
  • Texas Oncology - Fort Worth 12th Avenue
  • MD Anderson Cancer Center / University of Texas
  • MD Anderson Cancer Center Leukemia Group
  • Texas Oncology - Central Austin Cancer Center
  • Cancer Centers of South Texas - HOAST
  • Texas Oncology - Waco
  • Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
  • Virginia Cancer Specialists, PC
  • Puget Sound Cancer Centers
  • Cancer Care Northwest
  • Yakima Valley Memorial Hospital / North Star Lodge

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Brentuximab vedotin 1.8 mg/kg

Brentuximab vedotin 2.4 mg/kg

Brentuximab vedotin 1.2 mg/kg

Arm Description

Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion

Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) by Investigator
Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

Secondary Outcome Measures

Complete Remission (CR) Rate by Investigator
Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Duration of Objective Response by Kaplan-Meier Analysis
Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Duration of Complete Response by Kaplan-Meier Analysis
Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Progression-Free Survival by Kaplan-Meier Analysis
Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Laboratory Abnormalities >/= Grade 3
Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)
Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)
Incidence of Anti-therapeutic Antibodies (ATA)
Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.

Full Information

First Posted
October 24, 2011
Last Updated
February 5, 2016
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01461538
Brief Title
Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Official Title
A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (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
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Anemia, Refractory, With Excess of Blasts, Solid Tumors
Keywords
Acute Lymphoid Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia, Solid Tumors, Anemia, Refractory, with Excess of Blasts, Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Immunotherapy, Monomethyl Auristatin E

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brentuximab vedotin 1.8 mg/kg
Arm Type
Experimental
Arm Description
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Arm Title
Brentuximab vedotin 2.4 mg/kg
Arm Type
Experimental
Arm Description
Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
Arm Title
Brentuximab vedotin 1.2 mg/kg
Arm Type
Experimental
Arm Description
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
Adcetris; SGN-35
Intervention Description
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
Adcetris; SGN-35
Intervention Description
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
Adcetris; SGN-35
Intervention Description
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) by Investigator
Description
Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Time Frame
Up to approximately 3 years
Secondary Outcome Measure Information:
Title
Complete Remission (CR) Rate by Investigator
Description
Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Time Frame
Up to approximately 3 years
Title
Duration of Objective Response by Kaplan-Meier Analysis
Description
Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Time Frame
Up to approximately 2 years
Title
Duration of Complete Response by Kaplan-Meier Analysis
Description
Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Time Frame
Up to approximately 2 years
Title
Progression-Free Survival by Kaplan-Meier Analysis
Description
Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
Time Frame
Up to approximately 2 years
Title
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Description
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Time Frame
Up to approximately 3 years
Title
Laboratory Abnormalities >/= Grade 3
Description
Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category
Time Frame
Up to approximately 3 years
Title
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)
Time Frame
Up to approximately 3 years
Title
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)
Time Frame
Up to approximately 3 years
Title
Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
Time Frame
Up to approximately 3 years
Title
Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)
Time Frame
Up to approximately 3 years
Title
Incidence of Anti-therapeutic Antibodies (ATA)
Description
Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.
Time Frame
Up to approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy Have failed, refused, or have been deemed ineligible for standard therapy Measurable disease Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70 Exclusion Criteria: Primary diagnosis of lymphoma or central nervous system (CNS) malignancy History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years Evidence of active cerebral/meningeal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Josephson, MD
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
35294-3300
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Minnesota Oncology Hematology P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5055
Country
United States
Facility Name
Willamette Valley Cancer and Research / USOR
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Northwest Cancer Specialists, P.C.
City
Tulatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
St. Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology - Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Texas Oncology - Dallas Presbyterian
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Oncology Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
Texas Oncology - Fort Worth 12th Avenue
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4003
Country
United States
Facility Name
MD Anderson Cancer Center Leukemia Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology - Central Austin Cancer Center
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Cancer Centers of South Texas - HOAST
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology - Waco
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Puget Sound Cancer Centers
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Yakima Valley Memorial Hospital / North Star Lodge
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29222199
Citation
Albany C, Einhorn L, Garbo L, Boyd T, Josephson N, Feldman DR. Treatment of CD30-Expressing Germ Cell Tumors and Sex Cord Stromal Tumors with Brentuximab Vedotin: Identification and Report of Seven Cases. Oncologist. 2018 Mar;23(3):316-323. doi: 10.1634/theoncologist.2017-0544. Epub 2017 Dec 8.
Results Reference
derived
PubMed Identifier
26994848
Citation
Borate U, Mehta A, Reddy V, Tsai M, Josephson N, Schnadig I. Treatment of CD30-positive systemic mastocytosis with brentuximab vedotin. Leuk Res. 2016 May;44:25-31. doi: 10.1016/j.leukres.2016.02.010. Epub 2016 Feb 27.
Results Reference
derived
PubMed Identifier
23624209
Citation
Giannatempo P, Paolini B, Miceli R, Raggi D, Nicolai N, Fare E, Catanzaro M, Biasoni D, Torelli T, Stagni S, Piva L, Mariani L, Salvioni R, Colecchia M, Gianni AM, Necchi A. Persistent CD30 expression by embryonal carcinoma in the treatment time course: prognostic significance of a worthwhile target for personalized treatment. J Urol. 2013 Nov;190(5):1919-24. doi: 10.1016/j.juro.2013.04.057. Epub 2013 Apr 25.
Results Reference
derived

Learn more about this trial

Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

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