A Randomized Phase 2 Trial of Brentuximab Vedotin (SGN35, NSC# 749710), or Crizotinib (NSC#749005, Commercially Labeled) in Combination With Chemotherapy for Newly Diagnosed Patients With Anaplastic Large Cell Lymphoma (ALCL)

Who is this study for? Patients with Large Cell Lymphoma
What treatments are being studied? Cyclophosphamide+Cytarabine+Dexamethasone+Doxorubicin Hydrochloride+Etoposide+Ifosfamide+Methotrexate
Status: Completed
Location: See all (154) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in targeted way and delivers vedotin to kill them. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy is more effective than crizotinib and combination chemotherapy in treating anaplastic large cell lymphoma.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 21
Healthy Volunteers: f
View:

• Newly diagnosed patients with histologically proven ALCL (International Classification of Diseases for Oncology \[ICD-0\] code: 9714/3)

• Disease must be cluster of differentiation (CD)30 positive

• Disease must be anaplastic lymphoma kinase (ALK) positive (defined by local institutional standards)

• Patients must have stage II, III, or IV disease

• Patients must have a life expectancy of \>= 8 weeks

• Adequate Liver Function Defined As:

• Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)

• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x upper limit of normal (ULN) for age; for the purpose of this study, the ULN for ALT is 45 U/L (within 7 days prior to enrollment)

• If the lab abnormality is thought to be due to the lymphoma the patient is eligible and dose adjustments should be made

• Adequate Cardiac Function Defined As:

• Shortening fraction of \>= 27% by echocardiogram, or

• Ejection fraction of \>= 50% by radionuclide angiogram

• Adequate Pulmonary Function Defined As:

• Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry \> 92% while breathing room air unless current dysfunction is due to the lymphoma in which case the patient is eligible

Locations
United States
Alabama
Children's Hospital of Alabama
Birmingham
Arkansas
Arkansas Children's Hospital
Little Rock
Arizona
Phoenix Childrens Hospital
Phoenix
California
Kaiser Permanente Downey Medical Center
Downey
City of Hope Comprehensive Cancer Center
Duarte
Loma Linda University Medical Center
Loma Linda
Miller Children's and Women's Hospital Long Beach
Long Beach
Cedars Sinai Medical Center
Los Angeles
Children's Hospital Los Angeles
Los Angeles
Valley Children's Hospital
Madera
UCSF Benioff Children's Hospital Oakland
Oakland
Children's Hospital of Orange County
Orange
Lucile Packard Children's Hospital Stanford University
Palo Alto
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Naval Medical Center -San Diego
San Diego
Rady Children's Hospital - San Diego
San Diego
UCSF Medical Center-Mission Bay
San Francisco
UCSF Medical Center-Parnassus
San Francisco
Colorado
Children's Hospital Colorado
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver
Connecticut
Connecticut Children's Medical Center
Hartford
Yale University
New Haven
Washington, D.c.
Children's National Medical Center
Washington D.c.
Delaware
Alfred I duPont Hospital for Children
Wilmington
Florida
Golisano Children's Hospital of Southwest Florida
Fort Myers
University of Florida Health Science Center - Gainesville
Gainesville
Nemours Children's Clinic-Jacksonville
Jacksonville
Nicklaus Children's Hospital
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami
AdventHealth Orlando
Orlando
Arnold Palmer Hospital for Children
Orlando
Nemours Children's Hospital
Orlando
Orlando Health Cancer Institute
Orlando
Nemours Children's Clinic - Pensacola
Pensacola
Johns Hopkins All Children's Hospital
St. Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa
Tampa General Hospital
Tampa
Saint Mary's Hospital
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta
Augusta University Medical Center
Augusta
Memorial Health University Medical Center
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Honolulu
University of Hawaii Cancer Center
Honolulu
Iowa
Blank Children's Hospital
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
Boise
Illinois
Lurie Children's Hospital-Chicago
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
University of Illinois
Chicago
Advocate Children's Hospital-Oak Lawn
Oak Lawn
Saint Jude Midwest Affiliate
Peoria
Southern Illinois University School of Medicine
Springfield
Indiana
Ascension Saint Vincent Indianapolis Hospital
Indianapolis
Riley Hospital for Children
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
Lexington
Norton Children's Hospital
Louisville
Louisiana
Children's Hospital New Orleans
New Orleans
Ochsner Medical Center Jefferson
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital Cancer Center
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
Sinai Hospital of Baltimore
Baltimore
Maine
Maine Children's Cancer Program
Scarborough
Michigan
Ascension Saint John Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Michigan State University Clinical Center
East Lansing
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids
Beaumont Children's Hospital-Royal Oak
Royal Oak
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis
University of Minnesota/Masonic Cancer Center
Minneapolis
Mayo Clinic in Rochester
Rochester
Missouri
Columbia Regional
Columbia
Children's Mercy Hospitals and Clinics
Kansas City
Mercy Hospital Saint Louis
St Louis
Washington University School of Medicine
St Louis
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
Mission Hospital
Asheville
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Charlotte
Duke University Medical Center
Durham
Wake Forest University Health Sciences
Winston-salem
Nebraska
Children's Hospital and Medical Center of Omaha
Omaha
University of Nebraska Medical Center
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon
New Jersey
Hackensack University Medical Center
Hackensack
Morristown Medical Center
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick
Newark Beth Israel Medical Center
Newark
Saint Joseph's Regional Medical Center
Paterson
New Mexico
University of New Mexico Cancer Center
Albuquerque
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas
Summerlin Hospital Medical Center
Las Vegas
Sunrise Hospital and Medical Center
Las Vegas
University Medical Center of Southern Nevada
Las Vegas
New York
Albany Medical Center
Albany
Roswell Park Cancer Institute
Buffalo
NYU Winthrop Hospital
Mineola
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Memorial Sloan Kettering Cancer Center
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York
NYP/Weill Cornell Medical Center
New York
University of Rochester
Rochester
State University of New York Upstate Medical University
Syracuse
Montefiore Medical Center - Moses Campus
The Bronx
New York Medical College
Valhalla
Ohio
Children's Hospital Medical Center of Akron
Akron
Cincinnati Children's Hospital Medical Center
Cincinnati
Cleveland Clinic Foundation
Cleveland
Rainbow Babies and Childrens Hospital
Cleveland
Nationwide Children's Hospital
Columbus
Dayton Children's Hospital
Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
Portland
Oregon Health and Science University
Portland
Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Penn State Children's Hospital
Hershey
Children's Hospital of Philadelphia
Philadelphia
Saint Christopher's Hospital for Children
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Pittsburgh
Rhode Island
Rhode Island Hospital
Providence
South Carolina
Medical University of South Carolina
Charleston
Prisma Health Richland Hospital
Columbia
BI-LO Charities Children's Cancer Center
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
T C Thompson Children's Hospital
Chattanooga
East Tennessee Childrens Hospital
Knoxville
Saint Jude Children's Research Hospital
Memphis
The Children's Hospital at TriStar Centennial
Nashville
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
Dell Children's Medical Center of Central Texas
Austin
Driscoll Children's Hospital
Corpus Christi
Medical City Dallas Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
El Paso Children's Hospital
El Paso
Cook Children's Medical Center
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston
Children's Hospital of San Antonio
San Antonio
Methodist Children's Hospital of South Texas
San Antonio
University of Texas Health Science Center at San Antonio
San Antonio
Scott and White Memorial Hospital
Temple
Utah
Primary Children's Hospital
Salt Lake City
Virginia
Inova Fairfax Hospital
Falls Church
Children's Hospital of The King's Daughters
Norfolk
Naval Medical Center - Portsmouth
Portsmouth
Virginia Commonwealth University/Massey Cancer Center
Richmond
Washington
Seattle Children's Hospital
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Spokane
Madigan Army Medical Center
Tacoma
Mary Bridge Children's Hospital and Health Center
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
Madison
Children's Hospital of Wisconsin
Milwaukee
Time Frame
Start Date: 2013-11-13
Completion Date: 2024-03-31
Participants
Target number of participants: 137
Treatments
Experimental: Arm BV (brentuximab vedotin, combination chemotherapy)
COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5.~COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.
Experimental: Arm CZ (crizotinib, combination chemotherapy)
COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A.~COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib PO BID as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.
Authors
Violet Shen, Debra L. Friedman, Lisa L. Hartman, Kimo C. Stine, Virginia L. Harrod, Angela R. Girvin, John F. Kuttesch, Kenneth J. Cohen, Elyssa M. Rubin, Haydar A. Frangoul, Neyssa M. Marina, Nina S. Kadan-Lottick, Alissa Kahn, Marcio H. Malogolowkin, Jessica C. Hochberg, Anna B. Pawlowska, Douglas S. Hawkins, Vinod K. Gidvani-Diaz, Julio C. Barredo, Matthew A. Kutny, Rene Y. McNall-Knapp, Eric J. Lowe, Mary L. Schmidt, Jennifer L. McNeer, Melinda G. Pauly, Mariko Sato, Ashok B. Raj, Ronnie W. Neuberg, Jessica Boklan, Keith J. August, Anne F. Reilly, Lisa Gennarini, Melanie A. Comito, Stanton C. Goldman, Neerav N. Shukla, Michael S. Isakoff, John J. Letterio, Kayelyn J. Wagner, Joel A. Kaplan, Phillip E. Barnette, Howard M. Katzenstein, Rabi Hanna, Timothy C. Griffin, Vincent F. Giusti, Jaszianne A. Tolbert, Juan F. Rico, Don E. Eslin, William B. Slayton, Lolie C. Yu, Mark J. Mogul, Kamnesh R. Pradhan, Aron Flagg, Mark A. Ranalli, Leo Mascarenhas, Peri Kamalakar, Ray C. Pais, Jamie L. Dargart, Sheri L. Spunt, Adonis N. Lorenzana, Kenneth M. Heym, Gerardo Quezada, Andrew L. Pendleton, Shelton A. Viola, Renuka Gera, Vikramjit S. Kanwar, Barbara A. Gruner, Yoko T. Udaka, Lisa G. Roth, Michelle L. Hermiston, Craig Lotterman, Burton E. Appel, Meret Henry, Colleen H. McDonough, Kimberly J. Davies, Hadi Sawaf, Aghiad Chamdin, Thomas B. Russell, Arlene S. Redner, Robert M. Cooper, Richard A. Drachtman, Nicholas W. McGregor, Jacqueline M. Kraveka, Robert G. Irwin, Carla B. Golden, Douglas J. Scothorn, Matthew J. Barth, Aaron R. Weiss, Cameron K. Tebbi, Fouad M. Hajjar, Judy L. Felgenhauer, Minnie Abromowitch, Wade T. Kyono, Emi H. Caywood, Robert J. Fallon, Bethany M. Mikles, Gregory P. Brandt, Gregory A. Hale, Marshall A. Schorin, Lisa M. McGregor, Stacy L. Cooper, Christina M. Wiedl, John T. Sandlund, Nichole L. Bryant, Wendy L. Woods-Swafford, Susan G. Kreissman, Jeffrey R. Andolina, Sara Chaffee, Philip M. Monteleone, Stuart L. Cramer, Guy H. Grayson, Gregory E. Halligan, Bassem I. Razzouk, Robert J. Hayashi, Yung S. Yim, Alan K. Ikeda, Enrique A. Escalon, Nkechi I. Mba, Janice F. Olson, Laura K. Gowans, Martha M. Pacheco, Rebecca E. McFall, Michael K. Richards, Wayne L. Furman, Steven J. Kuerbitz, Joanna L. Weinstein, Koh B. Boayue, Jeffrey H. Schwartz, Mark E. Weinblatt, Sharon L. Gardner, Kala Y. Kamdar, Suzanne Shusterman, Mary A. Bonilla, Peter D. Cole, Nanette H. Grana, Teena Bhatla, Jeffrey S. Dome, Melissa A. Forouhar, Steven L. Halpern, Kelly W. Maloney, Emad K. Salman, Stuart H. Gold, Lars M. Wagner, Vlad C. Radulescu, David L. Becton, Paul D. Harker-Murray, Eugenia Chang, Albert Kheradpour, Bethany G. Sleckman, Jean M. Tersak, Jason M. Fixler, Linda C. Stork, David S. Dickens, Alyssa T. Reddy, Vonda L. Crouse, Narayana Gowda
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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