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

Phase 4

Completed

• Conditions: Lymphoma
• Interventions: Drug: Brentuximab vedotin

• 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

Study Timeline

• Study First Submitted: 2013-07-01
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-29
• Study Start: 2014-01-23
• Primary Completion: 2021-05-04
• Results First Submitted: 2022-05-04
• Results First Submitted QC: 2022-05-04
• Results First Posted: 2022-05-26
• Study Completion: 2024-08-29
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-29
• Last Update Posted: 2025-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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
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
Duration of Response (DOR) 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 stem cell transplant (SCT), or discontinued treatment due to undocumented PD after the last adequate disease assessment.
Progression-free Survival (PFS) 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) Per IRF	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.
Overall Survival (OS)	Until disease progression, death, or end of study (Up to approximately 10.7 years)	OS is defined as the time from start of study treatment to date of death due to any cause.
Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin	Until disease progression, death, or end of study (Up to approximately 10.7 years)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher)	From first dose up to 30 days post last dose of study drug (Up to approximately 1 year)	An adverse event (AE): 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 medicinal product. TEAE was defined as any AE that started after the first administration of study drug in this continuation study. Serious TEAEs: 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 Antibody-drug Conjugate (ADC) at the End of Infusion	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
Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin	Up to 16 cycles (each cycle = 21 days)

Trial Locations

Locations (40)

ZNA Stuivenberg; 🇧🇪 Antwerp, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Clinical Hospital Centre Rijeka; 🇭🇷 Rijeka, Croatia

Clinical Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia

Clinical Hospital Dubrava; 🇭🇷 Zagreb, Croatia

Fakultni nemocnice Brno; 🇨🇿 Brno, Czechia

Fakultni nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

Fakultni nemocnice Kralovske Vinohrady; 🇨🇿 Prague, Czechia

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