Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

Lymphoma Clinical Trial

Official title:

A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01909934
• Other study ID #: C25006
• Secondary ID: 2012-004128-39U1
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 30, 2014
• Est. completion date: October 4, 2024

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 4, 2024
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large-Cell, Anaplastic

Intervention

Drug:
• Brentuximab vedotin
Brentuximab vedotin IV infusion

Locations

Country	Name	City	State
Belgium	ZNA Stuivenberg	Antwerpen
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	UZ Leuven	Leuven
Croatia	Clinical Hospital Centre Rijeka	Rijeka
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Croatia	Clinical Hospital Dubrava	Zagreb
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Pecsi Tudomanyegyetem	Pecs
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Malopolskie Centrum Medyczne s.c.	Krakow
Poland	SPZOZ MSW zWarminsko-MazurskimCen.Onko.wOlsztynie	Olsztyn
Poland	Centrum Onkologii-Instytut im. M. Sklodowskiej Curie	Warszawa
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisboa
Portugal	Centro Hospitalar do Porto, E.P.E. - Hospital de Santo Antonio	Porto
Portugal	Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE	Porto
Romania	Policlinica de Diagnostic Rapid SA	Brasov
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Spitalul Clinic Coltea	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures	Targu Mures
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	ICO lHospitalet Hospital Duran i Reynals	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Pamukkale Uni. Med. Fac.	Denizli
Turkey	Istanbul Bilim University Medical Fac.	Istanbul
Turkey	Dokuz Eylul University Faculty of Medicine	Izmir
Turkey	Ege University Medical Faculty	Izmir
Turkey	Erciyes University Medical Faculty	Kayseri
United Kingdom	Birmingham Heartlands Hospital	Birmingham	West Midlands
United Kingdom	The Christie	Manchester	Greater Manchester
United Kingdom	Royal Cornwall Hospital	Truro	Cornwall

Sponsors (2)

Lead Sponsor	Collaborator
Takeda	Takeda Development Center Americas, Inc.

Countries where clinical trial is conducted

Belgium,  Croatia,  Czechia,  Hungary,  Poland,  Portugal,  Romania,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	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.	Up to data cut-off date: 04 May 2021 (Up to approximately 7 years)
Secondary	Duration of Response (DOR) as Per IRF	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.	Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Secondary	Progression-free Survival (PFS) as Per IRF	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.	Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Secondary	Complete Remission Rate (CRR)	CRR is defined as percentage of participants with CR. CR is defined as the disappearance of all evidence of disease.	Until disease progression, death, or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Secondary	Overall Survival (OS)	OS is defined as the time from start of study treatment to date of death due to any cause.	Until death or the data cut-off date: 4 May 2021 (Up to approximately 7 years)
Secondary	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)
Secondary	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events, Related Adverse Events and Adverse Events by Severity (Grade 3 or Higher)	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.	From first dose up to 30 days post last dose of study drug (Up to approximately 17 months)
Secondary	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
Secondary	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
Secondary	Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE)		Cycle 1, Day 1 and Cycle 3, Day 1 at the end of infusion
Secondary	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)