Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
- Registration Number
- NCT01909934
- Lead Sponsor
- Takeda
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brentuximab Vedotin 1.8 mg/kg Brentuximab vedotin Participants received brentuximab vedotin 1.8 mg/kg as a 30 minute intravenous (IV) infusion on Day 1 of each 3 week cycle. Participants with stable disease or better and without unacceptable toxicity were to receive a minimum of 8 cycles with the opportunity to receive a maximum of 16 cycles.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to data cut-off date: 04 May 2021 (Up to approximately 7 years) ORR was defined as the percentage of participants with a complete remission (CR) or partial remission (PR) by Independent Review Facility (IRF) response assessment according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs), Serious Adverse Events, Related Adverse Events and Adverse Events by Severity (Grade 3 or Higher) From first dose up to 30 days post last dose of study drug (Up to approximately 17 months) An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug. Serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is a medically important event.
Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE) Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion Duration of Response (DOR) as Per IRF Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) DOR was defined as the time between initial response and documented tumor progression in the subset of participants who achieved an objective response, either CR or PR. DOR per IRF was based upon the radiological assessment of measured lesions from an independent review facility. DOR was censored on the date of the last disease assessment documenting absence of progressive disease (PD) for participants who were lost to follow-up, withdrew consent, started a new anticancer therapy other than SCT, or discontinued treatment due to undocumented PD after the last adequate disease assessment.
Overall Survival (OS) Until death or the data cut-off date: 4 May 2021 (Up to approximately 7 years) OS is defined as the time from start of study treatment to date of death due to any cause.
Progression-free Survival (PFS) as Per IRF Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) PFS is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS per IRF is based upon the radiological assessment from an independent review facility.
Complete Remission Rate (CRR) Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease.
Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years) Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antidrug Antibody (Nab) to Brentuximab Vedotin Up to 16 cycles (each cycle = 21 days)
Trial Locations
- Locations (40)
Malopolskie Centrum Medyczne s.c.
🇵🇱Krakow, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Clinical Hospital Centre Zagreb
ðŸ‡ðŸ‡·Zagreb, Croatia
UZ Leuven
🇧🇪Leuven, Belgium
Clinical Hospital Dubrava
ðŸ‡ðŸ‡·Zagreb, Croatia
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
ZNA Stuivenberg
🇧🇪Antwerpen, Belgium
Hospital de Braga
🇵🇹Braga, Portugal
Debreceni Egyetem Klinikai Kozpont
ðŸ‡ðŸ‡ºDebrecen, Hungary
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
🇵🇹Porto, Portugal
Semmelweis Egyetem
ðŸ‡ðŸ‡ºBudapest, Hungary
Policlinica de Diagnostic Rapid SA
🇷🇴Brasov, Romania
The Christie
🇬🇧Manchester, Greater Manchester, United Kingdom
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
SPZOZ MSW zWarminsko-MazurskimCen.Onko.wOlsztynie
🇵🇱Olsztyn, Poland
Spitalul Clinic Coltea
🇷🇴Bucuresti, Romania
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Pamukkale Uni. Med. Fac.
🇹🇷Denizli, Turkey
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, United Kingdom
Erciyes University Medical Faculty
🇹🇷Kayseri, Turkey
Dokuz Eylul University Faculty of Medicine
🇹🇷Izmir, Turkey
ICO lHospitalet Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Pecsi Tudomanyegyetem
ðŸ‡ðŸ‡ºPecs, Hungary
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
🇵🇱Warszawa, Poland
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Istanbul Bilim University Medical Fac.
🇹🇷Istanbul, Turkey
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Birmingham Heartlands Hospital
🇬🇧Birmingham, West Midlands, United Kingdom
Clinical Hospital Centre Rijeka
ðŸ‡ðŸ‡·Rijeka, Croatia
Spitalul Clinic Colentina
🇷🇴Bucuresti, Romania
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo Antonio
🇵🇹Porto, Portugal
Spitalul Clinic Judetean de Urgenta Targu Mures
🇷🇴Targu Mures, Romania
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium