Clinical trial NCT01909934: Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Official title: A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphoma
Keywords: Lymphoma
Anaplastic Large-cell
Relapsed
Refractory
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
monomethyl auristatin E
Drug Therapy
Immunotherapy
Hematologic Diseases
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Takeda Development Center Americas, Inc.
First posted: 2013-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride \[hydroxydaunorubicin\], vincristine sulfate \[Oncovin\], and prednisone \[CHOP\] or equivalent multiagent chemotherapy regimens with curative intent).


Eligibility criteria: Inclusion Criteria:

* Male or female participants age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy
* Bidimensional measurable disease
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence
* Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence
* Clinical laboratory values as specified in the study protocol

Exclusion Criteria:

* Previous treatment with brentuximab vedotin.
* Previously received an allogeneic transplant.
* Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma \[ALCL\] (participants whose ALCL has transformed to sALCL are eligible).
* Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
* Female participants who are lactating and breastfeeding or pregnant
* Known human immunodeficiency virus (HIV) positive
* Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)
Secondary outcomes:
measure: Duration of Response (DOR) as Per IRF
timeFrame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
measure: Progression-free Survival (PFS) as Per IRF
timeFrame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
measure: Complete Remission Rate (CRR)
timeFrame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
measure: Overall Survival (OS)
timeFrame: Until death or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
measure: Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin
timeFrame: Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events, Related Adverse Events and Adverse Events by Severity (Grade 3 or Higher)
timeFrame: From first dose up to 30 days post last dose of study drug (Up to approximately 17 months)
measure: Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion
timeFrame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
measure: Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody
timeFrame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
measure: Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE)
timeFrame: Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
measure: Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antidrug Antibody (Nab) to Brentuximab Vedotin
timeFrame: Up to 16 cycles (each cycle = 21 days)
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Rijeka
country: Croatia
facility: Clinical Hospital Centre Rijeka
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne s.c.
city: Olsztyn
country: Poland
facility: SPZOZ MSW zWarminsko-MazurskimCen.Onko.wOlsztynie
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
city: Brasov
country: Romania
facility: Policlinica de Diagnostic Rapid SA
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO lHospitalet Hospital Duran i Reynals
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Denizli
country: Turkey
facility: Pamukkale Uni. Med. Fac.
city: Istanbul
country: Turkey
facility: Istanbul Bilim University Medical Fac.
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Izmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Manchester
country: United Kingdom
facility: The Christie
state: Greater Manchester
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: West Midlands
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: