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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 is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT02594163
First received: October 30, 2015
Last updated: December 1, 2016
Last verified: November 2016
  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: 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


Estimated Enrollment: 110
Study Start Date: October 2015
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: January 2020 (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02594163

Contacts
Contact: Nikki Bindra, BDS +1 434 951 3969 BindraNikki@prahs.com

  Show 51 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Katherine Ruffner, MD Seattle Genetics, Inc.
  More Information

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02594163     History of Changes
Other Study ID Numbers: SGN35-023
Study First Received: October 30, 2015
Last Updated: December 1, 2016

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

ClinicalTrials.gov processed this record on April 28, 2017