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Trial record 1 of 1 for:    SGN35-023
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Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-cell Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02594163
First Posted: November 2, 2015
Last Update Posted: November 1, 2017
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.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
  Purpose
This is a randomized, open-label, multicenter, Phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin in combination with rituximab and bendamustine for the treatment of patients with relapsed or refractory CD30-positive diffuse large B-cell lymphoma (DLBCL) after failure of second-line salvage therapy or as second-line treatment in patients ineligible for autologous stem cell transplant (ASCT).

Condition Intervention Phase
Diffuse Large B-cell Lymphoma Refractory Follicular B-cell Non-Hodgkin's Lymphoma Drug: Brentuximab Vedotin Drug: Rituximab Drug: Bendamustine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Phase 2 Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for Relapsed or Refractory CD30-Positive Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • The objective response rate (ORR) [ Time Frame: Up to approximately 12 months (at End of Treatment (EoT) visit) ]
    A comparison between the 2 arms of imaging (Computed tomography(CT) and Positron emission tomography (PET) or CT/PET; PET no longer required after documented postbaseline [18F]fluorodeoxyglucose-negative PET)


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Up to approximately 4 years 3 months ]
    A comparison between the 2 arms of first documentation of disease progression/relapse, or death due to any cause, whichever occurs first

  • Complete remission (CR) rate [ Time Frame: Up to approximately 12 months (at End of Treatment (EoT) visit) ]
    A comparison between the 2 arms of first documentation of disease progression/relapse, or death due to any cause, whichever occurs first

  • Duration of response (DOR) [ Time Frame: Up to approximately 4 years 3 months ]
    A comparison between the 2 arms of the time from first observation of response (Partial remission (PR)/Partial metabolic response (PMR)+Complete remission (CR)/Complete metabolic response (CMR)) to disease progression/relapse or death from any cause, whichever occurs first

  • Overall survival (OS) [ Time Frame: Up to approximately 4 years 3 months ]
    A comparison between the 2 arms of the time from first dose of study medication to death due to any cause

  • Number and severity of adverse events [ Time Frame: Through 30-37 days following last dose (at end of treatment visit). ]
    A comparison of adverse events between the 2 arms in the study


Enrollment: 25
Study Start Date: October 2015
Study Completion Date: September 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab Vedotin
Subjects randomized to the brentuximab vedotin arm will receive IV infusions of brentuximab vedotin followed by bendamustine on day 1, and rituximab followed by bendamustine on day 2 of each 21 day cycle.
Drug: Brentuximab Vedotin
Other Name: Adcetris
Drug: Rituximab
Other Name: Rituxan
Drug: Bendamustine
Other Name: Treanda
Active Comparator: Rituximab,Bendamustine control
Subjects randomized to the control arm will receive IV infusions of rituximab on day 1 or day 2 and bendamustine on both days 1 and 2 of each 21 day cycle.
Drug: Rituximab
Other Name: Rituxan
Drug: Bendamustine
Other Name: Treanda

Detailed Description:
Patients will be randomized in a 1:1 manner to receive rituximab plus bendamustine with or without brentuximab vedotin. Patients who respond to combination treatment containing brentuximab vedotin and do not experience excessive toxicity may receive additional single-agent brentuximab vedotin following combination treatment, for up to an additional 10 cycles (up to 16 total cycles of treatment).
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients with confirmed CD30-positive DLBCL or grade 3b follicular non-Hodgkin lymphoma (NHL).
  2. Patients must have relapsed or refractory disease following:

    1. second-line or greater salvage systemic therapy, or
    2. frontline cytotoxic systemic therapy, for patients who are ineligible for stem cell transplant (SCT).
  3. Age 18 years and older.
  4. Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET).
  5. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
  6. Acceptable blood test results.
  7. Females of childbearing potential must have a negative pregnancy test result within 7 days prior to the first dose of study drug.
  8. Females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of brentuximab vedotin or 12 months following the last dose of rituximab, whichever is later.
  9. Patients must provide written informed consent.

Exclusion Criteria:

  1. History of another invasive malignancy that has not been in remission for at least 1 year. (Exceptions are nonmelanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma, and cervical carcinoma or a squamous intraepithelial lesion on PAP smear).
  2. History of progressive multifocal leukoencephalopathy (PML).
  3. Cerebral/meningeal disease related to the underlying malignancy, unless definitively treated.
  4. Viral, bacterial, or fungal infection within 2 weeks prior to the first dose of treatment.
  5. Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug.
  6. Females who are pregnant or breastfeeding.
  7. Known allergy to any study drug or ingredient contained in the drug formulation of any of the study drugs.
  8. Known to be positive for hepatitis B. Known to have active hepatitis C infection or on antiviral therapy for hepatitis C within the last 6 months.
  9. Known to be positive for human immunodeficiency virus (HIV).
  10. Patients with previous allogeneic stem cell transplant.
  11. Previous treatment with brentuximab vedotin or bendamustine.
  12. Intolerable toxicity to prior rituximab therapy.
  13. Current therapy with other investigational agents.
  14. Lung disease unrelated to underlying malignancy.
  15. History of a stroke or transient ischemic attack, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to the first dose of treatment.
  16. Congestive heart failure.
  17. Significant peripheral sensory or motor neuropathy at the start of the study.
  Contacts and Locations
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): NCT02594163


  Show 50 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Thomas Manley, MD Seattle Genetics, Inc.
  More Information

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02594163     History of Changes
Other Study ID Numbers: SGN35-023
First Submitted: October 30, 2015
First Posted: November 2, 2015
Last Update Posted: November 1, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bendamustine Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action