Study of Brentuximab Vedotin Combined With RCHOP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01925612
First received: August 15, 2013
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as A+RCHOP) in patients with DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups.


Condition Intervention Phase
Lymphoma, B-cell
Lymphoma, Large B-cell, Diffuse
Drug: brentuximab vedotin
Drug: rituximab
Drug: vincristine
Drug: cyclophosphamide
Drug: prednisone
Drug: doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) as Front-line Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Complete remission rate [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Incidence of laboratory abnormalities [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A(1.2 mg/kg) + RCHOP
Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
Drug: brentuximab vedotin
1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
Other Name: Adcetris, SGN-35
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Experimental: A(1.8 mg/kg) + RCHOP
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
Drug: brentuximab vedotin
1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
Drug: rituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: vincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
Drug: cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Drug: prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
Drug: doxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
  • International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age
  • Stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB-IV disease
  • Measurable disease of at least 1.5 cm
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria:

  • Previous history of treated indolent lymphoma
  • History of another primary malignancy that has not been in remission for 3 years
  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: NCT01925612

Contacts
Contact: Terri Lowe 425-527-4000 tlowe@seagen.com

Locations
United States, Arizona
Arizona Oncology Associates, PC - HAL Recruiting
Phoenix, Arizona, United States, 85016
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Mahesh Seetharam, MD         
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Brianna Phye    626-256-4673    brbrophy@coh.org   
Principal Investigator: Lihua Elizabeth Budde, MD         
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305
Contact: Sabata Lund    650-725-6432    sclund@stanford.edu   
Principal Investigator: Ranjana Advani, MD         
United States, Colorado
Rocky Mountain Cancer Centers - Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: John Burke, MD         
United States, Minnesota
Mayo Clinic Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Referral Office    507-538-7623    ansell.stephen@mayo.edu   
Principal Investigator: Stephen Ansell, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Courtney Darkow    314-362-4206    cdarkow@dom.wustl.edu   
Principal Investigator: Nancy Bartlett, MD         
United States, New Jersey
Hematology and Oncology Associates of Northern New Jersey Recruiting
Morristown, New Jersey, United States, 07962
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Charles Farber, MD         
United States, Ohio
Mid Ohio Oncology/Hematology Inc Recruiting
Columbus, Ohio, United States, 43219
Contact: Nancy Merriman    614-383-6236    NMerriman@zangcenter.com   
Principal Investigator: Mark Knapp, MD         
United States, Oregon
Willamette Valley Cancer Institute and Research Center Recruiting
Springfield, Oregon, United States, 97477
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Christopher Yasenchak, MD         
Northwest Cancer Specialists, P.C. Recruiting
Tualatin, Oregon, United States, 97062
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Kathryn Kolibaba, MD         
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4095
Contact: Hie Sanjorjo    713-792-4255    psanjorjo@mdanderson.org   
Principal Investigator: Luis Fayad, MD         
Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Habte Yimer, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Karen Pena    801-213-4233    karen.pena@hci.utah.edu   
Principal Investigator: Ahmad Halwani, MD         
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Dipti Patel-Donnelly, MD         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Jaime Scott    804-628-1909    jscott@vcu.edu   
Principal Investigator: Beata Holkova, MD         
United States, Washington
Yakima Valley Memorial Hospital / North Star Lodge Recruiting
Yakima, Washington, United States, 98902
Contact: Melissa Jansky    281-863-6658    Melissa.Jansky@Mckesson.com   
Principal Investigator: Thomas Boyd, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Thomas Manley, MD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01925612     History of Changes
Other Study ID Numbers: SGN35-017
Study First Received: August 15, 2013
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Immunotherapy
Lymphoma, B-cell
Lymphoma, Large B-cell, Diffuse
Monomethyl auristatin E

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Doxorubicin
Prednisone
Vincristine
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on September 29, 2014