Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461538
• Other study ID #: SGN35-013
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2011
• Last updated: February 5, 2016
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoid Leukemia
• Acute Myeloid Leukemia
• Anemia, Refractory, with Excess of Blasts
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Solid Tumors

Intervention

Drug:
• brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
• brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
• brentuximab vedotin
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion

Locations

Country	Name	City	State
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	Rocky Mountain Cancer Centers - Aurora	Aurora	Colorado
United States	Texas Oncology - Bedford	Bedford	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care	Blacksburg	Virginia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Texas Oncology - Dallas Presbyterian	Dallas	Texas
United States	Texas Oncology - Medical City Dallas	Dallas	Texas
United States	Texas Oncology Denton South	Denton	Texas
United States	City of Hope	Duarte	California
United States	Puget Sound Cancer Centers	Edmonds	Washington
United States	Willamette Valley Cancer and Research / USOR	Eugene	Oregon
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Texas Oncology - Fort Worth 12th Avenue	Fort Worth	Texas
United States	St. Francis Hospital	Greenville	South Carolina
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	MD Anderson Cancer Center Leukemia Group	Houston	Texas
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	Mayo Clinic Cancer Center	Jacksonville	Florida
United States	Minnesota Oncology Hematology P.A.	Minneapolis	Minnesota
United States	Ocala Oncology Center	Ocala	Florida
United States	PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists	Oxnard	California
United States	Texas Oncology - Central Austin Cancer Center	Round Rock	Texas
United States	Cancer Centers of South Texas - HOAST	San Antonio	Texas
United States	Cancer Care Northwest	Spokane Valley	Washington
United States	Northwest Cancer Specialists, P.C.	Tulatin	Oregon
United States	Texas Oncology - Waco	Waco	Texas
United States	Yakima Valley Memorial Hospital / North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Up to approximately 3 years	No
Secondary	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).	Up to approximately 3 years	No
Secondary	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).	Up to approximately 2 years	No
Secondary	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).	Up to approximately 2 years	No
Secondary	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	Up to approximately 2 years	No
Secondary	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.	Up to approximately 3 years	Yes
Secondary	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	Up to approximately 3 years	Yes
Secondary	Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)		Up to approximately 3 years	No
Secondary	Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)		Up to approximately 3 years	No
Secondary	Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)		Up to approximately 3 years	No
Secondary	Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)		Up to approximately 3 years	No
Secondary	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.	Up to approximately 3 years	Yes