Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01716806
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

Condition or disease Intervention/treatment Phase
Hodgkin Disease Peripheral T Cell Lymphoma Drug: brentuximab vedotin Drug: bendamustine Drug: dacarbazine Drug: nivolumab Phase 2

Detailed Description:
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy
Actual Study Start Date : October 31, 2012
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2024


Arm Intervention/treatment
Experimental: Part A: Brentuximab Vedotin in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Experimental: Part B: Brentuximab Vedotin + Dacarbazine in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Drug: dacarbazine
375 mg/m^2 every 3 weeks by IV infusion

Experimental: Part C: Brentuximab Vedotin + Bendamustine in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Drug: bendamustine
70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle

Experimental: Part D: Brentuximab Vedotin + Nivolumab in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Drug: nivolumab
3 mg/kg every 3 weeks by IV infusion

Experimental: Part E: Brentuximab Vedotin in HL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Experimental: Part F: Brentuximab Vedotin in PTCL Patients Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35




Primary Outcome Measures :
  1. Objective response rate (ORR) according to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C) [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]
    Defined as the proportion of patients with complete response (CR) or (PR)

  2. ORR according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D) [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]
  3. ORR according to modified Lugano criteria per blinded independent central review (BICR) (Parts E and F) [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months ]
  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months ]
  3. Complete remission (CR) rate [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]
    Defined as the proportion of patients with CR

  4. Duration of complete response [ Time Frame: Up to approximately 10 years ]
    Defined as the time from start of the first documentation of complete tumor response (CR) to the first documentation of tumor progression or death

  5. Duration of objective response [ Time Frame: Up to approximately 10 years ]
    Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or death

  6. Progression-free survival [ Time Frame: Up to approximately 10 years ]
    Defined as the time from start of study treatment to first documentation of tumor progression or death due to any cause

  7. Disease control rate [ Time Frame: Up to approximately 10 years ]
    Defined as the proportion of patients with CR, PR, or stable disease (SD)

  8. ORR according to Lugano criteria per BICR (Parts E and F) [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]
  9. B symptom resolution rate [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]
    Defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period

  10. Blood concentrations of brentuximab vedotin [ Time Frame: Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes ]
  11. Incidence of brentuximab vedotin antitherapeutic antibodies (ATA) [ Time Frame: Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose ]
    Defined as the proportion of patients who develop ATA to brentuximab vedotin at any time during the study

  12. Blood concentrations of nivolumab (Part D only) [ Time Frame: Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes ]
  13. Incidence of nivolumab antitherapeutic antibodies (ATA) (Part D only) [ Time Frame: Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose ]
    Defined as the proportion of patients who develop ATA to nivolumab at any time during the study

  14. Overall survival (Parts E and F only) [ Time Frame: Up to approximately 5 years ]
    Defined as the time from start of study treatment to date of death due to any cause



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:

  • Parts A, B, C, and D: 60 years of age or older
  • Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
  • Treatment-naive patients with CD30-expressing PTCL (Part F)
  • Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
  • Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:

    • A CIRS score of 10 or greater
    • Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
  • Measurable disease of at least 1.5 cm as documented by radiographic technique
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)

Exclusion Criteria:

  • Symptomatic neurologic disease compromising IADLs or requiring medication
  • History of progressive multifocal leukoencephalopathy
  • Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
  • Concurrent use of other investigational agents
  • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
  • History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
  • Part D only:

    • Received any prior immune-oncology therapy
    • History of known or suspected autoimmune disease
    • Prior allogeneic stem cell transplant
    • History of cerebral vascular event within 6 months of first dose of study drug
    • Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
    • Known history of pancreatitis
  • Parts D, E, and F only:

    • Known cerebral/meningeal disease related to the underlying malignancy
    • Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment

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): NCT01716806


Contacts
Layout table for location contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
Show Show 29 study locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Robert Sims, MD Seattle Genetics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01716806    
Other Study ID Numbers: SGN35-015
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Keywords provided by Seattle Genetics, Inc.:
Antibody-Drug Conjugate
Antibodies, Monoclonal
Hematologic Diseases
Hodgkin Disease
Antigens, CD30
Lymphoma
monomethylauristatin E
Drug Therapy
CD30-expression
PTCL
Additional relevant MeSH terms:
Layout table for MeSH terms
Hodgkin Disease
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Nivolumab
Bendamustine Hydrochloride
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action