Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01909934
Recruitment Status : Active, not recruiting
First Posted : July 29, 2013
Last Update Posted : February 22, 2022
Sponsor:
Collaborator:
Takeda Development Center Americas, Inc.
Information provided by (Responsible Party):
Takeda

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 participants 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
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 : January 30, 2014
Actual Primary Completion Date : May 4, 2021
Estimated Study Completion Date : October 4, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 participants who achieve stable disease or better.
Other Names:
  • SGN-35
  • ADCETRIS


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Objective Response Rate (ORR - Defined as Percentage of Participants with Objective Response) 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 participant) ]
    To determine the antitumor efficacy of single-agent brentuximab vedotin as measured by ORR in participants with relapsed or refractory sALCL following at least 1 multiagent chemotherapy regimen.


Secondary Outcome Measures :
  1. Duration of Response as per IRF [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last participant) ]
    To determine the duration of response with brentuximab vedotin.

  2. Progression-free Survival (PFS) as per IRF [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last participant) ]
    To determine progression-free survival with brentuximab vedotin.

  3. Complete Remission Rate (CR - Defined as Percentage of Participants with CR) [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last participant) ]
    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 participant) ]
    To determine overall survival with brentuximab vedotin.

  5. Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment with Brentuximab Vedotin [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last participant) ]
  6. Percentage of Participants with Adverse Events (AEs), Serious Adverse Events, Related Adverse Events and Adverse Events by Severity [ Time Frame: 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.

  7. Percentage of Participants with Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 30 days post last dose of study drug (up to approximately 17 months) ]
  8. Cmax: Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE) [ Time Frame: Cycles 1, 2, 3, Day 1: Predose (at start of infusion) and end of infusion, Cycles 1, 3, Days 2, 15: At the start of infusion; Cycle 4 and subsequent cycles, Day 1: Predose (at the start of infusion) and at the end of infusion [Cycle length=21 days] ]
  9. Ceoi: Plasma Concentration at the End of Infusion for Brentuximab Vedotin [ Time Frame: Cycles 1, 2, 3, Day 1: Predose (at start of infusion) and end of infusion, Cycles 1, 3, Days 2, 15: At the start of infusion; Cycle 4 and subsequent cycles, Day 1: Predose (at the start of infusion) and at the end of infusion [Cycle length=21 days] ]
  10. Percentage of Participants with Presence of Anti-Therapeutic Antibodies (ATA) to Brentuximab Vedotin [ Time Frame: Cycles 1, 2, 3, Day 1: Predose (at start of infusion) and end of infusion, Cycles 1, 3, Days 2, 15: At the start of infusion; Cycle 4 and subsequent cycles, Day 1: Predose (at the start of infusion) and at the end of infusion [Cycle length=21 days] ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909934


Locations
Show Show 40 study locations
Sponsors and Collaborators
Takeda
Takeda Development Center Americas, Inc.
Investigators
Layout table for investigator information
Study Director: Study Director Takeda
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01909934    
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    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Brentuximab Vedotin
Antineoplastic Agents, Immunological
Antineoplastic Agents