Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
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 |
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.
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Seattle Genetics, Inc. |
United States,
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 |
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