Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
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ClinicalTrials.gov Identifier: NCT01461538 |
Recruitment Status :
Completed
First Posted : October 28, 2011
Results First Posted : March 4, 2016
Last Update Posted : March 4, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoid Leukemia Acute Myeloid Leukemia Anemia, Refractory, With Excess of Blasts Solid Tumors | Drug: brentuximab vedotin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 84 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Brentuximab vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
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Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: Adcetris; SGN-35 |
Experimental: Brentuximab vedotin 2.4 mg/kg
Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
|
Drug: brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: Adcetris; SGN-35 |
Experimental: Brentuximab vedotin 1.2 mg/kg
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
|
Drug: brentuximab vedotin
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
Other Name: Adcetris; SGN-35 |
- Objective Response Rate (ORR) by Investigator [ Time Frame: Up to approximately 3 years ]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).
- Complete Remission (CR) Rate by Investigator [ Time Frame: Up to approximately 3 years ]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 [ Time Frame: Up to approximately 2 years ]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 [ Time Frame: Up to approximately 2 years ]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 [ Time Frame: Up to approximately 2 years ]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 [ Time Frame: Up to approximately 3 years ]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 [ Time Frame: Up to approximately 3 years ]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) [ Time Frame: Up to approximately 3 years ]
- Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ]
- Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) [ Time Frame: Up to approximately 3 years ]
- Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ]
- Incidence of Anti-therapeutic Antibodies (ATA) [ Time Frame: Up to approximately 3 years ]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.

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461538

Study Director: | Neil Josephson, MD | Seagen Inc. |
Responsible Party: | Seagen Inc. |
ClinicalTrials.gov Identifier: | NCT01461538 |
Other Study ID Numbers: |
SGN35-013 |
First Posted: | October 28, 2011 Key Record Dates |
Results First Posted: | March 4, 2016 |
Last Update Posted: | March 4, 2016 |
Last Verified: | February 2016 |
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 |
Leukemia Leukemia, Myeloid, Acute Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Anemia, Refractory Anemia, Refractory, with Excess of Blasts Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid Anemia |
Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myelodysplastic Syndromes Bone Marrow Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |