Study of Brentuximab Vedotin Combined With RCHOP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Lymphoma, B-cell Lymphoma, Large B-cell, Diffuse |
| Intervention | Drug: brentuximab vedotin Drug: brentuximab vedotin Drug: rituximab Drug: vincristine Drug: cyclophosphamide Drug: prednisone Drug: doxorubicin |
| Phase | Phase 2 |
| Sponsor | Seattle Genetics, Inc. |
| Responsible Party | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier | NCT01925612 |
| First Received | August 15, 2013 |
| Last Updated | March 27, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 15, 2013 |
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| Last Updated Date | March 27, 2014 |
| Start Date | August 2013 |
| Estimated Primary Completion Date | May 2017 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Study of Brentuximab Vedotin Combined With RCHOP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL) |
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| 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) |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: brentuximab vedotin 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles Other Names: Adcetris; SGN-35Drug: brentuximab vedotin 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles Other Names: Adcetris; SGN-35Drug: 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 2mg 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 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | May 2017 |
| Estimated Primary Completion Date | May 2015 |
| Eligibility 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 - 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01925612 |
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| Other Study ID Numbers | SGN35-017 |
| Has Data Monitoring Committee | No |
| Information Provided By | Seattle Genetics, Inc. |
| Study Sponsor | Seattle Genetics, Inc. |
| Collaborators | Not Provided |
| Investigators | Study Director: Dana Kennedy, PharmD, BCOP Seattle Genetics, Inc. |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| Arizona Oncology Associates, PC - HAL | Glendale, Arizona, United States, 85308 Contact: Dixie Roberson | 281-863-4669 | Dixie.Roberson@mckesson.comPrincipal Investigator: Mahesh Seetharam, M.D. Recruiting |
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| City of Hope Department of Hematology and Hematopoietic Cell Transplantation | Duarte, California, United States, 91010-3000 Contact: Brianna Phye | 626-256-467389448 | brbrophy@coh.orgPrincipal Investigator: Lihua Elizabeth Budde, MD PhD Recruiting |
| Stanford Cancer Center | Stanford, California, United States, 94305-5821 Contact: Sabata Lund | 650-725-6432 | sclund@stanford.eduPrincipal Investigator: Ranjana Advani, MD Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States, 55905 Contact: Mayo Clinic Clinical Trials ReferralOffice | 507-538-7623Principal Investigator: Stephen Ansell, M.D. Ph.D Recruiting |
| Washington University School of Medicine | St. Louis, Missouri, United States, 63110 Contact: Courtney L. Darkow | 314-362-4206 | cdarkow@dom.wustl.eduPrincipal Investigator: Nancy Bartlett, MD Recruiting |
| Hematology and Oncology Associates of Northern New Jersey | Morristown, New Jersey, United States, 07962 Contact: Dixie Roberson | 281-863-4669 | Dixie.Roberson@mckesson.comPrincipal Investigator: Charles Farber, MD, Ph.D Recruiting |
| Mid Ohio Oncology/Hematology Inc | Columbus, Ohio, United States, 43219 Contact: Nancy Merriman | 614-383-6236 | NMerriman@zangcenter.comPrincipal Investigator: Mark Knapp, MD Recruiting |
| Northwest Cancer Specialists, P.C. | Tualatin, Oregon, United States, 97062 Contact: Dixie Roberson | 281-863-4669 | Dixie.Roberson@mckesson.comPrincipal Investigator: Christopher A Yasenchak, M.D. Recruiting |
| MD Anderson Cancer Center / University of Texas | Houston, Texas, United States, 77030-4003 Contact: Hie Sanjorjo | 713-792-4255 | psanjorjo@mdanderson.orgPrincipal Investigator: Luis Fayad, MD; FACP Recruiting |
| Texas Oncology - Tyler | Tyler, Texas, United States, 75702 Contact: Dixie Roberson | 281-863-4669 | Dixie.Roberson@mckesson.comPrincipal Investigator: Habte Yimer, M.D. Recruiting |
| University of Utah | Salt Lake City, Utah, United States, 84112-5550 Contact: Karen Pena | 801-213-4233 | karen.pena@hci.utah.eduPrincipal Investigator: Ahmad Halwani, M.D. Recruiting |
| Virginia Cancer Specialists, PC | Fairfax, Virginia, United States, 22031 Contact: Nicole Hodge | 703-528-7303 | Nicole.Hodge@USOncology.comPrincipal Investigator: Dipti Patel-Donnelly, M.D. Recruiting |
| Virginia Commonwealth University Medical Center | Richmond, Virginia, United States, 23298 Contact: Jaime Scott | 804-628-1909 | jscott@vcu.eduPrincipal Investigator: Beata Holkova, M.D. Recruiting |
| Yakima Valley Memorial Hospital / North Star Lodge | Yakima, Washington, United States, 98902 Contact: Dixie Roberson | 281-863-4669 | Dixie.Roberson@mckesson.comPrincipal Investigator: Thomas Boyd, M.D. Recruiting |