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Study of Rituximab and Bendamustine With or Without Brentuximab Vedotin for CD30 Positive Diffuse Large B-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: NCT02594163
Recruitment Status : Terminated (Sponsor decision based on portfolio prioritization)
First Posted : November 1, 2015
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Refractory Follicular B-cell Non-Hodgkin's Lymphoma Drug: Brentuximab Vedotin Drug: Rituximab Drug: Bendamustine Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : October 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 1 year ]
    ORR is defined as the percentage of patients who achieve a Complete Response (CR) (including Complete Metabolic Response (CMR)) or Partial Response (PR) (including Partial Metabolic Response (PMR)) as best response to combination therapy on study


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Up to 11.8 months ]
    PFS is defined as the time from randomization to disease progression/relapse, receipt of subsequent lymphoma chemotherapy other than the components of the study treatment regimen, or death from any cause, whichever occurs first.

  2. Complete Remission (CR) Rate [ Time Frame: Approximately 1 year ]
    CRR is the proportion of patients who achieve CR (including Complete Metabolic Response (CMR)) as best response to combination therapy on study.

  3. Duration of Response (DOR) [ Time Frame: Up to 10.5 months ]
    DOR is defined as the time from first observation of response to disease progression/relapse, receipt of subsequent lymphoma chemotherapy other than the components of the study treatment regimen, or death from any cause, whichever occurs first.

  4. Overall Survival (OS) [ Time Frame: Up to 1.5 years ]
    OS is defined as the time randomization to death from any cause

  5. Number and Severity of Adverse Events (AEs) [ Time Frame: Approximately 1 year ]
    All AEs are included in the summaries, unless treatment-emergent is specified.


Eligibility Criteria
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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:

  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
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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


Locations
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Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Thomas Manley, MD Seagen Inc.
  Study Documents (Full-Text)

Documents provided by Seagen Inc.:
Study Protocol  [PDF] July 13, 2016
Statistical Analysis Plan  [PDF] July 19, 2018

More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT02594163    
Other Study ID Numbers: SGN35-023
First Posted: November 1, 2015    Key Record Dates
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
 Brentuximab Vedotin
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action