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Trial record 4 of 881 for:    "Reticulum Cell Sarcoma"

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

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ClinicalTrials.gov Identifier: NCT01909934
Recruitment Status : Recruiting
First Posted : July 29, 2013
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

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

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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 : October 30, 2019
Estimated Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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




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.



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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

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


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

  Show 40 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.

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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    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
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:
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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
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs