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CompletedNCT01461538Updated Mar 4, 2016Results posted

Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

A Phase 2 interventional study of brentuximab vedotin and brentuximab vedotin in Acute Lymphoid Leukemia, Acute Myeloid Leukemia and Anemia, Refractory, With Excess of Blasts, sponsored by Seagen Inc.. Completed at 29 sites in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2016-03-04.

Sponsored by Seagen Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
84
Allocation
Non-randomized
Ages
6 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 84 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Seagen Inc. is the lead sponsor of 84 studies on the registry; 1 is open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Brentuximab vedotin 1.8 mg/kg

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

    Drug: brentuximab vedotin

  • Experimental
    Brentuximab vedotin 2.4 mg/kg

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

    Drug: brentuximab vedotin

  • 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

Interventions

  • Drugbrentuximab vedotin

    1.8 mg/kg every 3 weeks by intravenous (IV) infusion

    Also known as: Adcetris; SGN-35

  • Drugbrentuximab vedotin

    2.4 mg/kg every 3 weeks by intravenous (IV) infusion

    Also known as: Adcetris; SGN-35

  • Drugbrentuximab vedotin

    1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion

    Also known as: Adcetris; SGN-35

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. 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).

    Time frame: Up to approximately 3 years

  2. 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).

    Time frame: Up to approximately 2 years

  3. 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).

    Time frame: Up to approximately 2 years

  4. 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

    Time frame: Up to approximately 2 years

  5. 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.

    Time frame: Up to approximately 3 years

  6. 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

    Time frame: Up to approximately 3 years

  7. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)

    Time frame: Up to approximately 3 years

  8. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)

    Time frame: Up to approximately 3 years

  9. Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

    Time frame: Up to approximately 3 years

  10. Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)

    Time frame: Up to approximately 3 years

  11. 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.

    Time frame: Up to approximately 3 years

07

Results

Posted Mar 4, 2016

Participant flow

Oct 2011 - Dec 2014

Participant flow — Overall Study
MilestoneBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
Started46289
Completed28207
Not completed1882
Withdrew: Death1562
Withdrew: Study stopped by sponsor210
Withdrew: Withdrawal by subject110

Outcome measures

PrimaryObjective 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).

Time frame:
Up to approximately 3 years
Reported as:
Number · percentage of participants
Objective Response Rate (ORR) by Investigator
percentage of participantsSolid TumorsLeukemia
Objective Response Rate (ORR) by Investigator12 (4.9 to 22.9)14 (1.8 to 42.8)
SecondaryComplete 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).

Time frame:
Up to approximately 3 years
Reported as:
Number · percentage of participants
Complete Remission (CR) Rate by Investigator
percentage of participantsSolid TumorsLeukemia
Complete Remission (CR) Rate by Investigator2 (0.0 to 9.1)0 (0 to 23.2)
SecondaryDuration 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).

Time frame:
Up to approximately 2 years
Reported as:
Median · months
Duration of Objective Response by Kaplan-Meier Analysis
monthsSolid TumorsLeukemia
Duration of Objective Response by Kaplan-Meier Analysis2.9 (1.5 to 23.5)2.1 (1.0 to 3.1)
SecondaryDuration 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).

Time frame:
Up to approximately 2 years
Reported as:
Median · months
Duration of Complete Response by Kaplan-Meier Analysis
monthsSolid TumorsLeukemia
Duration of Complete Response by Kaplan-Meier Analysis22.3 (22.3 to 22.3)—
SecondaryProgression-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

Time frame:
Up to approximately 2 years
Reported as:
Median · months
Progression-Free Survival by Kaplan-Meier Analysis
monthsSolid TumorsLeukemia
Progression-Free Survival by Kaplan-Meier Analysis2.1 (1.3 to 2.8)0.7 (0.7 to 1.3)
SecondaryAdverse 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.

Time frame:
Up to approximately 3 years
Reported as:
Number · participants
Adverse Events by Severity, Seriousness, and Relationship to Treatment
participantsBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
Any TEAE45289
TEAE related to study drug31245
TEAE with severity grade >/=331187
Discontinued treatment due to adverse event522
Serious adverse event24135
Serious adverse event related to study drug562
Deaths (within 30 days of last dose)1062
SecondaryLaboratory 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

Time frame:
Up to approximately 3 years
Reported as:
Number · participants
Laboratory Abnormalities >/= Grade 3
participantsBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
Any >/= Grade 3 laboratory abnormality24129
Alanine aminotransferase high011
Albumin low230
Alkaline phosphatase high010
Aspartate aminotransferase high010
Bilirubin high010
Calcium low110
Glucose high210
Glucose low100
Sodium low420
Urate high200
Prothrombin INR high001
Absolute neutrophil count low625
Hemoglobin low403
Leukocytes high011
Leukocytes low404
Lymphocytes high120
Lymphocytes low931
Neutrophils low637
Platelets low447
SecondaryBrentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)
Time frame:
Up to approximately 3 years
Reported as:
Geometric mean · ug/mL
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)
ug/mLBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)40 ± 2654 ± 2825 ± 23
SecondaryBrentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)
Time frame:
Up to approximately 3 years
Reported as:
Geometric mean · ug/mL
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)
ug/mLBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)0.36 ± 1800.55 ± 2101.5 ± 48
SecondaryMaximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
Time frame:
Up to approximately 3 years
Reported as:
Geometric mean · ng/mL
Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
ng/mLBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)4.0 ± 786.2 ± 712.6 ± 83
SecondaryBrentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)
Time frame:
Up to approximately 3 years
Reported as:
Geometric mean · ng/mL
Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)
ng/mLBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)0.22 ± 920.35 ± 821.5 ± 65
SecondaryIncidence 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.

Time frame:
Up to approximately 3 years
Reported as:
Number · participants
Incidence of Anti-therapeutic Antibodies (ATA)
participantsBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
Baseline (BL) negative33218
BL negative, negative post-BL14148
BL negative, transiently positive post-BL1860
BL negative, persistently positive post-BL110
BL positive320
BL positive, negative post-BL100
BL positive, transiently positive post-BL210
BL positive, persistently positive post-BL010

Adverse events

Collected over Up to approximately 3 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BV 1.8 mg/kg Q3Week—24/46 (52.2%)42/46 (91.3%)
BV 2.4 mg/kg Q3Week—13/28 (46.4%)28/28 (100%)
BV 1.2 mg/kg Q1Week—5/9 (55.6%)8/9 (88.9%)
Most frequent serious events
Showing 10 of 55
Most frequent serious events
EventBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
Febrile neutropeniaBlood and lymphatic system disorders1/460/281/9
Atrial fibrillationCardiac disorders1/460/281/9
DiarrheaGastrointestinal disorders1/461/281/9
StomatitisGastrointestinal disorders0/460/281/9
PyrexiaGeneral disorders1/461/281/9
Hepatic failureHepatobiliary disorders0/460/281/9
Bacterial sepsisInfections and infestations0/460/281/9
PneumoniaInfections and infestations2/461/281/9
DehydrationMetabolism and nutrition disorders2/460/281/9
Acute myeloid leukemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/462/281/9
Most frequent other events
Showing 10 of 70
Most frequent other events
EventBV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1Week
FatigueGeneral disorders26/4610/283/9
AnemiaBlood and lymphatic system disorders6/461/284/9
NauseaGastrointestinal disorders13/4611/280/9
ThrombocytopeniaBlood and lymphatic system disorders1/460/283/9
DyspneaRespiratory, thoracic and mediastinal disorders8/466/283/9
Decreased appetiteMetabolism and nutrition disorders11/469/282/9
DiarrheaGastrointestinal disorders14/465/282/9
ConstipationGastrointestinal disorders9/467/281/9
VomitingGastrointestinal disorders11/467/280/9
Peripheral sensory neuropathyNervous system disorders8/467/281/9

Baseline characteristics

All participants who received treatment. One additional patient enrolled, but withdrew prior to treatment group assignment.

Age, Continuous
Age, Continuous(years)BV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1WeekTotal
Median64 (24 to 85)64 (18 to 85)76 (33 to 87)65 (18 to 87)
Sex: Female, Male
Sex: Female, Male(Participants)BV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1WeekTotal
Female2112437
Male2516546
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)BV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1WeekTotal
Hispanic or Latino2204
Not Hispanic or Latino4426979
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1WeekTotal
American Indian or Alaska Native0000
Asian1203
Native Hawaiian or Other Pacific Islander0000
Black or African American2002
White4225976
More than one race0000
Unknown or Not Reported1102
Region of Enrollment
Region of Enrollment(participants)BV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1WeekTotal
United States4628983
Eastern Cooperative Oncology Group Performance Status
Eastern Cooperative Oncology Group Performance Status(participants)BV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1WeekTotal
0135119
12015540
20011
3-50000
Missing138223
Height
Height(centimeters (cm))BV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1WeekTotal
Median170.2 (142 to 188)171.9 (150 to 186)167.6 (144 to 180)170.2 (142 to 188)
Weight
Weight(kilograms (kg))BV 1.8 mg/kg Q3WeekBV 2.4 mg/kg Q3WeekBV 1.2 mg/kg Q1WeekTotal
Median74.8 (46 to 109)75.1 (49 to 104)73.4 (45 to 137)74.8 (45 to 137)

1 further baseline measures are reported on the registry.

08

Study locations

29 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294-3300, United States
  • City of Hope
    Duarte, California 91010-3000, United States
  • PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
    Oxnard, California 93030, United States
  • Rocky Mountain Cancer Centers - Aurora
    Aurora, Colorado 80012, United States
  • Mayo Clinic Cancer Center
    Jacksonville, Florida 32224, United States
  • Ocala Oncology Center
    Ocala, Florida 34471, United States
  • Indiana University Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Minnesota Oncology Hematology P.A.
    Minneapolis, Minnesota 55404, United States
  • New York Oncology Hematology, P.C.
    Albany, New York 12206, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106-5055, United States
  • Willamette Valley Cancer and Research / USOR
    Eugene, Oregon 97401, United States
  • Northwest Cancer Specialists, P.C.
    Tulatin, Oregon 97062, United States
  • St. Francis Hospital
    Greenville, South Carolina 29605, United States
  • Texas Oncology - Bedford
    Bedford, Texas 76022, United States
  • Texas Oncology - Medical City Dallas
    Dallas, Texas 75230, United States
  • Texas Oncology - Dallas Presbyterian
    Dallas, Texas 75231, United States
  • Texas Oncology Denton South
    Denton, Texas 76210, United States
  • Texas Oncology - Fort Worth 12th Avenue
    Fort Worth, Texas 76104, United States
  • MD Anderson Cancer Center / University of Texas
    Houston, Texas 77030-4003, United States
  • MD Anderson Cancer Center Leukemia Group
    Houston, Texas 77030, United States
  • Texas Oncology - Central Austin Cancer Center
    Round Rock, Texas 78731, United States
  • Cancer Centers of South Texas - HOAST
    San Antonio, Texas 78229, United States
  • Texas Oncology - Waco
    Waco, Texas 76712, United States
  • Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
    Blacksburg, Virginia 24060, United States
  • Virginia Cancer Specialists, PC
    Fairfax, Virginia 22031, United States
  • Puget Sound Cancer Centers
    Edmonds, Washington 98026, United States
  • Cancer Care Northwest
    Spokane Valley, Washington 99216, United States
  • Yakima Valley Memorial Hospital / North Star Lodge
    Yakima, Washington 98902, United States
09

References and documents

Publications

  • 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. PubMed 29222199 ↗
  • 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. PubMed 26994848 ↗
  • 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. PubMed 23624209 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01461538
Lead sponsor
Seagen Inc.
Responsible party
Sponsor
First posted
Oct 28, 2011
Start date
Oct 2011
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Mar 4, 2016
Last update
Mar 4, 2016

Study contacts

Neil Josephson, MD
study director · Seagen Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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