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

• ClinicalTrials.gov Identifier: NCT01909934
• Recruitment Status: Recruiting
• First Posted: July 29, 2013
• Last Update Posted: November 11, 2019
• Sponsor: Millennium Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Takeda ( Millennium Pharmaceuticals, Inc. )

Study Description

Brief Summary:

This is a single-arm, open-label, multicenter, phase 4 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with relapsed or refractory Systemic Anaplastic Large Cell Lymphoma (SALCL).

Condition or disease	Intervention/treatment	Phase
Anaplastic Large-cell Lymphoma	Drug: brentuximab vedotin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
• Actual Study Start Date: October 1, 2013
• Estimated Primary Completion Date: September 30, 2020
• Estimated Study Completion Date: April 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Brentuximab vedotin; 1.8 mg/kg IV infusion	Drug: brentuximab vedotin; Brentuximab vedotin will be administered as a single intravenous (IV) infusion over 30 minutes on Day 1 of each 3 week cycle for up to a maximum of 16 cycles and should be administered for a minimum of 8 cycles for patients who achieve stable disease or better.; Other Names: SGN-35; ADCETRIS

Outcome Measures

Primary Outcome Measures :

1. Objective Response Rate (ORR) as assessed by an independent review facility (IRF) according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ]
   To determine the antitumor efficacy of single-agent brentuximab vedotin as measured by ORR in patients with relapsed or refractory sALCL following at least 1 multiagent chemotherapy regimen

Secondary Outcome Measures :

1. Duration of response [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ]
   To determine the duration of response with brentuximab vedotin.
2. Progression-free survival (PFS) [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ]
   To determine progression-free survival with brentuximab vedotin.
3. Complete remission rate (CR) [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ]
   To determine the complete remission rate with brentuximab vedotin.
4. Overall Survival [ Time Frame: Until death or study closure (up to 5 years after the enrollment of the last patient) ]
   To determine overall survival with brentuximab vedotin.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female patients 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 patients 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 patients 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.
• Patients with current diagnosis of primary cutaneous ALCL (patients whose ALCL has transformed to sALCL are eligible).
• Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
• Female patients 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

Contacts and Locations

Contacts

Contact: Takeda Study Registration Call Center; +1-866-835-2233; medical@mlnm.com

  Show 40 Study Locations

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

• Study Director: Medical Monitor; Millennium Pharmaceuticals, Inc.

More Information

• Responsible Party: Millennium Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01909934 History of Changes
• Other Study ID Numbers: C25006; 2012-004128-39 ( EudraCT Number ); U1111-1154-9784 ( Registry Identifier: WHO ); REec-2014-0649 ( Registry Identifier: REec ); 13/NI/0072 ( Registry Identifier: NRES )
• First Posted: July 29, 2013
• Last Update Posted: November 11, 2019
• Last Verified: November 2019

Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):

monomethyl auristatin E; Lymphoma; Anaplastic Large-cell; Relapsed; Refractory; Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; Drug Therapy; Immunotherapy; Hematologic Diseases

Additional relevant MeSH terms:

Neoplasms by Histologic Type; Neoplasms; Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Antibodies; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs