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A Study of Brentuximab Vedotin in Adults Age 60 and Above With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

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ClinicalTrials.gov Identifier: NCT01716806
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : May 29, 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 in patients 60 years or older for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). 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 in patients who are age 60 years or more. 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 Adults Age 60 and Above
Actual Study Start Date : October 2012
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 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/m2 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/m2 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 [ 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 ]
  4. Duration of complete response [ Time Frame: Up to approximately 10 years ]
  5. Duration of objective response [ Time Frame: Up to approximately 10 years ]
  6. Progression-free survival [ Time Frame: Up to approximately 10 years ]
  7. Disease control rate [ Time Frame: Up to approximately 10 years ]
  8. B symptom resolution rate [ Time Frame: Through 1 month following last dose; up to approximately 16 months ]
  9. 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 ]
  10. 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 ]
  11. Blood concentrations of nivolumab [ 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 ]
  12. Incidence of nivolumab antitherapeutic antibodies (ATA) [ 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 ]
  13. Overall survival (Parts E and F only) [ Time Frame: Up to approximately 5 years ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
  • Treatment-naïve patients with CD30-expressing PTCL (Part F)
  • 75+ years of age or 60+ years and have depressed ejection fraction or moderately severe renal dysfunction (Parts E and F only)
  • Ineligible for initial conventional combination chemotherapy for HL (Parts A, B, C, D, E) or CD30-expressing PTCL (Part F), or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
  • 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

Exclusion Criteria:

  • Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication
  • 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)

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
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

  Show 24 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Bristol-Myers Squibb
Investigators
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Study Director: Linda Ho, MD Seattle Genetics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01716806     History of Changes
Other Study ID Numbers: SGN35-015
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 24, 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:
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Lymphoma
Hodgkin Disease
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies
Antibodies, Monoclonal
Nivolumab
Bendamustine Hydrochloride
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action