Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients with Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

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Status: Active

Description

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. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. 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 Criteria

Inclusion Criteria

  • 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
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • 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
  • If the lab abnormality is thought to be due to the lymphoma the patient is eligible and dose adjustments should be made
  • Shortening fraction of >= 27% by echocardiogram, or
  • Ejection fraction of >= 50% by radionuclide angiogram
  • 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

Exclusion Criteria

  • Patients with central nervous system (CNS) disease are not eligible
  • Patients with disease limited to the skin are not eligible, regardless of how wide-spread
  • Patients with stage I disease are not eligible
  • Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of ALCL or any cancer diagnosed previously are not eligible
  • Previous steroid treatment and/or radiation treatment is not allowed unless it is for the emergent management of a mediastinal mass; emergent steroid treatment and/or radiation treatment should stop once protocol therapy is initiated
  • Intrathecal chemotherapy prior to enrollment is allowed for the current diagnosis of ALCL as long as adequate cerebrospinal fluid (CSF) is obtained prior to administration of the intrathecal chemotherapy and subsequently demonstrated to be negative for ALCL
  • Female patients who are pregnant are not eligible; pregnancy tests must be obtained in girls who are post menarchal
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Sexually active patients of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of treatment and for 3 months after stopping treatment
  • Patients with Down syndrome are not eligible
  • Patients with an immunodeficiency that existed prior to diagnosis such as primary immunodeficiency syndromes or organ transplant recipients are not eligible
  • Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates with narrow therapeutic indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices including pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; the topical use of these medications (if applicable) is allowed
  • CYP3A4 inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole, clarithromycin, erythromycin, ritonavir, indinavir, nelfinavir, saquinavir, delavirdine, nefazodone, diltiazem, verapamil, and grapefruit juice are not eligible; the topical use of these medications (if applicable), e.g. 2% ketoconazole cream, is allowed
  • CYP3A4 inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, ritonavir, and St. John’s wort are not eligible; the topical use of these medications (if applicable) is allowed
  • Patients that are known to be positive for human immunodeficiency virus (HIV) are not eligible; note: inclusion of HIV positive patients will be considered at a later date
  • Patients who weigh < 10 kg are not eligible

Locations & Contacts

Alabama

Birmingham
Children's Hospital of Alabama
Status: Active
Contact: Alyssa Terry Reddy Email: helpdesk@childrensoncologygroup.org

Arizona

Phoenix
Phoenix Childrens Hospital
Status: Active
Contact: Jessica Boklan
Phone: 602-546-0920

Arkansas

Little Rock
Arkansas Children's Hospital
Status: Active
Contact: David L. Becton Email: helpdesk@childrensoncologygroup.org

California

Downey
Southern California Permanente Medical Group
Status: Active
Contact: Robert Michael Cooper
Phone: 626-564-3455
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Anna Beata Pawlowska
Phone: 800-826-4673 Email: becomingapatient@coh.org
Loma Linda
Loma Linda University Medical Center
Status: Temporarily closed to accrual
Contact: Albert Kheradpour
Phone: 909-558-3375
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: Active
Contact: Pamela Helen-Heilge Kempert Email: helpdesk@childrensoncologygroup.org
Los Angeles
Cedars Sinai Medical Center
Status: Active
Contact: Fataneh (Fae) Majlessipour
Phone: 310-423-8965
Children's Hospital Los Angeles
Status: Active
Contact: Leo Mascarenhas Email: helpdesk@childrensoncologygroup.org
Madera
Children's Hospital Central California
Status: Active
Contact: Vonda Lee Crouse Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Carla Barbara Golden Email: helpdesk@childrensoncologygroup.org
Orange
Children's Hospital of Orange County
Status: Active
Contact: Elyssa M. Rubin Email: helpdesk@childrensoncologygroup.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Contact: Sheri L Spunt Email: helpdesk@childrensoncologygroup.org
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Yung Soon Yim
Phone: 415-209-2686 Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Marcio Henrique Malogolowkin
Phone: 916-734-3089
San Diego
Naval Medical Center -San Diego
Status: Active
Contact: Shelton August Viola
Phone: 619-532-8712
Rady Children's Hospital - San Diego
Status: Active
Contact: William D. Roberts Email: helpdesk@childrensoncologygroup.org
San Francisco
UCSF Medical Center-Mission Bay
Status: Active
Contact: Michelle Lynn Hermiston
Phone: 877-827-3222

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Contact: Kelly Wilson Maloney Email: helpdesk@childrensoncologygroup.org
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: Active
Contact: Jennifer Jocelyn Clark Email: helpdesk@childrensoncologygroup.org

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Active
Contact: Michael Scott Isakoff Email: helpdesk@childrensoncologygroup.org
New Haven
Yale University
Status: Active
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Active
Contact: Evangeline J. Brown
Phone: 302-651-5755

District of Columbia

Washington
Children's National Medical Center
Status: Active
Contact: Jeffrey Stuart Dome Email: helpdesk@childrensoncologygroup.org

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Active
Contact: Emad K. Salman Email: helpdesk@childrensoncologygroup.org
Gainesville
University of Florida Health Science Center - Gainesville
Status: Temporarily closed to accrual
Contact: William Birdsall Slayton
Phone: 352-273-8675 Email: trials@cancer.ufl.edu
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org
Miami
Nicklaus Children's Hospital
Status: Active
Contact: Enrique Alberto Escalon Email: helpdesk@childrensoncologygroup.org
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Julio Cesar Barredo
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Active
Contact: Vincent Ferdinando Giusti
Phone: 321-843-2584
Florida Hospital Orlando
Status: Active
Contact: Fouad M. Hajjar
Phone: 407-303-2090 Email: FH.Cancer.Research@flhosp.org
Nemours Children's Hospital
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org
Pensacola
Nemours Children's Clinic - Pensacola
Status: Active
Contact: Evangeline J. Brown Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Nanette H. Grana Email: helpdesk@childrensoncologygroup.org
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Temporarily closed to accrual
Contact: Mark J. Mogul
Phone: 704-384-5369
Tampa General Hospital
Status: Active
Contact: Juan Felipe Rico
Phone: 813-844-8113 Email: hkourtellis@tgh.org
West Palm Beach
Saint Mary's Hospital
Status: Active
Contact: Narayana Gowda Email: helpdesk@childrensoncologygroup.org

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: Active
Contact: Melinda Gordon Pauly Email: helpdesk@childrensoncologygroup.org
Savannah
Memorial University Medical Center
Status: Active
Contact: Andrew L. Pendleton
Phone: 912-350-7887 Email: clayter1@memorialhealth.com

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Wade T. Kyono
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Eugenia Chang Email: helpdesk@childrensoncologygroup.org

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: Active
Contact: Joanna Lynn Weinstein Email: helpdesk@childrensoncologygroup.org
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Jennifer Lynn McNeer
Phone: 773-834-7424
University of Illinois
Status: Active
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Active
Contact: Rebecca Erin McFall Email: helpdesk@childrensoncologygroup.org
Peoria
Saint Jude Midwest Affiliate
Status: Active
Contact: Pedro A. De Alarcon
Phone: 888-226-4343
Springfield
Southern Illinois University School of Medicine
Status: Active
Contact: Gregory P. Brandt
Phone: 217-545-7929

Indiana

Indianapolis
Riley Hospital for Children
Status: Active
Contact: Kamnesh Ratnakar Pradhan
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Bassem I. Razzouk
Phone: 317-338-2194 Email: research@stvincent.org

Iowa

Des Moines
Blank Children's Hospital
Status: Active
Contact: Wendy Leigh Woods-Swafford Email: helpdesk@childrensoncologygroup.org
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Mariko Sato
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Lars Martin Wagner
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: Temporarily closed to accrual
Contact: Ashok B. Raj
Phone: 866-530-5516

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Craig Lotterman
Phone: 504-842-3708

Maine

Scarborough
Maine Children's Cancer Program
Status: Active
Contact: Aaron Robert Weiss Email: helpdesk@childrensoncologygroup.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Stacy L. Cooper
Phone: 410-955-8804 Email: jhcccro@jhmi.edu
Sinai Hospital of Baltimore
Status: Active
Contact: Jason M. Fixler
Phone: 410-601-6120 Email: pridgely@lifebridgehealth.org

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Contact: Kimberly Jan Davies
Phone: 877-442-3324

Michigan

Detroit
Saint John Hospital and Medical Center
Status: Active
Contact: Adonis N. Lorenzana
Phone: 734-712-3671
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Meret Henry
Phone: 313-576-9363
East Lansing
Michigan State University Clinical Center
Status: Active
Contact: Renuka Gera
Phone: 517-975-9547
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Temporarily closed to accrual
Contact: David Scott Dickens
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: Active
Contact: Michael Kerr Richards Email: helpdesk@childrensoncologygroup.org
University of Minnesota / Masonic Cancer Center
Status: Active
Contact: Peter Michael Gordon Email: helpdesk@childrensoncologygroup.org
Rochester
Mayo Clinic
Status: Active
Contact: Carola A. S. Arndt
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: Temporarily closed to accrual
Contact: Gail Cranshaw Megason
Phone: 601-815-6700

Missouri

Columbia
Columbia Regional
Status: Active
Contact: Barbara Anne Gruner Email: helpdesk@childrensoncologygroup.org
Kansas City
The Childrens Mercy Hospital
Status: Active
Contact: Keith Jason August Email: helpdesk@childrensoncologygroup.org
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Bethany Graham Sleckman
Phone: 314-251-6770
Washington University School of Medicine
Status: Active
Contact: Robert J. Hayashi
Phone: 800-600-3606 Email: info@siteman.wustl.edu

Nebraska

Omaha
Children's Hospital and Medical Center of Omaha
Status: Active
Contact: Minnie Abromowitch Email: helpdesk@childrensoncologygroup.org
University of Nebraska Medical Center
Status: Active
Contact: Minnie Abromowitch
Phone: 402-559-6941 Email: unmcrsa@unmc.edu

Nevada

Las Vegas
Children's Specialty Center of Nevada II
Status: Active
Contact: Alan K. Ikeda Email: helpdesk@childrensoncologygroup.org
Nevada Cancer Research Foundation CCOP
Status: Active
Contact: Nik Farahana Nik Abdul Rashid
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013 Email: research@sncrf.org
Sunrise Hospital and Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013 Email: research@sncrf.org
University Medical Center of Southern Nevada
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013 Email: research@sncrf.org

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Sara Chaffee
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Burton Eliot Appel
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: Active
Contact: Steven Lon Halpern
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Active
Contact: Richard A. Drachtman
Phone: 732-235-8675
Paterson
Saint Joseph's Regional Medical Center
Status: Active
Contact: Mary Ann Bonilla Email: helpdesk@childrensoncologygroup.org

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Koh B. Boayue
Phone: 505-925-0366 Email: LByatt@nmcca.org

New York

Albany
Albany Medical Center
Status: Active
Contact: Kenneth G. Lucas
Phone: 518-262-5513
Bronx
Montefiore Medical Center - Moses Campus
Status: Active
Contact: Lisa Gennarini
Phone: 718-904-2730 Email: aecc@aecom.yu.edu
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Matthew J. Barth
Phone: 877-275-7724
Mineola
NYU Winthrop Hospital
Status: Active
Contact: Mark E. Weinblatt
Phone: 516-663-3115
New Hyde Park
The Steven and Alexandra Cohen Children's Medical Center of New York
Status: Active
Contact: Arlene Sara Redner Email: helpdesk@childrensoncologygroup.org
New York
Columbia University / Herbert Irving Cancer Center
Status: Active
Contact: Alice Lee
Phone: 212-305-8615
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Temporarily closed to accrual
Contact: Teena Bhatla
Phone: 212-263-4434 Email: prmc.coordinator@nyumc.org
Memorial Sloan-Kettering Cancer Center
Status: Active
Contact: Neerav Narendra Shukla
Phone: 212-639-7202
Weill Medical College of Cornell University
Status: Active
Contact: Lisa Giulino Roth
Phone: 212-746-1848
Rochester
University of Rochester
Status: Active
Contact: Jeffrey Robert Andolina
Phone: 585-275-5830
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Philip M. Monteleone
Phone: 315-464-5476
Valhalla
New York Medical College
Status: Active
Contact: Jessica Cassara Hochberg
Phone: 914-594-3794

North Carolina

Asheville
Mission Hospital-Memorial Campus
Status: Active
Contact: Douglas James Scothorn
Phone: 828-213-4150
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Stuart Harrison Gold
Phone: 877-668-0683 Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Joel A. Kaplan
Phone: 704-355-2884
Durham
Duke University Medical Center
Status: Active
Contact: Susan G. Kreissman
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Thomas Bennett Russell
Phone: 336-713-6771

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Active
Contact: Steven J. Kuerbitz Email: helpdesk@childrensoncologygroup.org
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: Maureen Megan O'Brien Email: helpdesk@childrensoncologygroup.org
Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Aron Flagg
Phone: 866-223-8100
Rainbow Babies and Childrens Hospital
Status: Active
Contact: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Columbus
Nationwide Children's Hospital
Status: Active
Contact: Mark Anthony Ranalli Email: helpdesk@childrensoncologygroup.org
Dayton
Dayton Children's Hospital
Status: Active
Contact: Ayman Aly El-Sheikh Email: helpdesk@childrensoncologygroup.org
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: Active
Contact: Jamie L. Dargart
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Rene Yvonne McNall-Knapp
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

Portland
Oregon Health and Science University
Status: Active
Contact: Linda Claudette Stork
Phone: 503-494-1080 Email: trials@ohsu.edu

Pennsylvania

Hershey
Penn State Children's Hospital
Status: Active
Contact: Lisa MacNabb McGregor Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Contact: Anne Fitzpatrick Reilly Email: helpdesk@childrensoncologygroup.org
Saint Christopher's Hospital for Children
Status: Active
Contact: Gregory Emmett Halligan Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Jean M. Tersak Email: helpdesk@childrensoncologygroup.org

Rhode Island

Providence
Rhode Island Hospital
Status: Active
Contact: Jennifer J. Greene Welch
Phone: 401-444-1488

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Jacqueline M. Kraveka
Phone: 843-792-9321 Email: hcc-clinical-trials@musc.edu
Columbia
Palmetto Health Richland
Status: Active
Contact: Stuart Louis Cramer
Phone: 803-434-3680
Greenville
BI-LO Charities Children's Cancer Center
Status: Active
Contact: Nichole Leigh Bryant Email: helpdesk@childrensoncologygroup.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Kayelyn Jean Wagner
Phone: 605-312-3320 Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Chattanooga
T C Thompson Children's Hospital
Status: Temporarily closed to accrual
Contact: Manoo G. Bhakta Email: helpdesk@childrensoncologygroup.org
Knoxville
East Tennessee Childrens Hospital
Status: Temporarily closed to accrual
Contact: Ray C. Pais
Phone: 865-541-8266
Memphis
St. Jude Children's Research Hospital
Status: Active
Contact: John T. Sandlund Email: helpdesk@childrensoncologygroup.org
Nashville
The Children's Hospital at TriStar Centennial
Status: Active
Contact: Haydar A. Frangoul Email: helpdesk@childrensoncologygroup.org
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Debra L. Friedman
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Active
Contact: Amy Catherine Fowler Email: helpdesk@childrensoncologygroup.org
Corpus Christi
Driscoll Children's Hospital
Status: Active
Contact: Nkechi Ifeoma Mba Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Temporarily closed to accrual
Contact: Stanton Carl Goldman
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Martha Marie Pacheco
Phone: 214-648-7097
El Paso
El Paso Children's Hospital
Status: Active
Contact: Lisa Louise Rubin Hartman Email: helpdesk@childrensoncologygroup.org
Fort Worth
Cook Children's Medical Center
Status: Active
Contact: Kenneth Matthew Heym Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Kala Y. Kamdar
Phone: 713-798-1354 Email: burton@bcm.edu
San Antonio
Children's Hospital of San Antonio
Status: Active
Contact: Timothy C. Griffin Email: helpdesk@childrensoncologygroup.org
Methodist Children's Hospital of South Texas
Status: Active
Contact: Vinod Kumar Gidvani-Diaz Email: helpdesk@childrensoncologygroup.org
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800 Email: CTO@uthscsa.edu

Utah

Salt Lake City
Primary Children's Hospital
Status: Temporarily closed to accrual
Contact: Phillip Evan Barnette Email: helpdesk@childrensoncologygroup.org

Virginia

Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Marshall A. Schorin
Phone: 703-208-6650 Email: Stephanie.VanBebber@inova.org
Norfolk
Childrens Hospital-King's Daughters
Status: Active
Contact: Eric Jeffrey Lowe Email: helpdesk@childrensoncologygroup.org
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Christina Marie Wiedl Email: helpdesk@childrensoncologygroup.org

Washington

Seattle
Seattle Children's Hospital
Status: Active
Contact: Douglas S. Hawkins Email: helpdesk@childrensoncologygroup.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Judy L. Felgenhauer Email: helpdesk@childrensoncologygroup.org
Tacoma
Madigan Army Medical Center
Status: Active
Contact: Melissa Anne Forouhar
Phone: 253-968-0129 Email: mamcdci@amedd.army.mil
Mary Bridge Children's Hospital and Health Center
Status: Active
Contact: Robert G. Irwin Email: helpdesk@childrensoncologygroup.org

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Kenneth Brian De Santes
Phone: 800-622-8922
Milwaukee
Children's Hospital of Wisconsin
Status: Active
Contact: Paul David Harker-Murray
Phone: 414-955-4727 Email: MACCCTO@mcw.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the tolerability of brentuximab vedotin given in combination with standard chemotherapy (anaplastic large cell lymphoma [ALCL]99) and to determine the tolerability of crizotinib given in combination with chemotherapy (ALCL99).

II. To estimate the event free survival (EFS) of Arm brentuximab vedotin (BV) and Arm crizotinib (CZ) and contrast these to historical control data.

SECONDARY OBJECTIVES:

I. To determine the prognostic significance of minimal disseminated disease (MDD) at diagnosis and minimal residual disease (MRD) as measured by real-time (RT)-polymerase chain reaction (PCR) in peripheral blood.

OUTLINE: Patients are assigned or randomized into 1 of 2 treatment arms.

ARM BV:

COURSE A (COURSES 1, 3, AND 5): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, dexamethasone orally (PO) twice daily (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 (COURSES 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.

ARM CZ:

COURSE A (COURSES 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 (COURSES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
Eric Jeffrey Lowe

Trial IDs

Primary ID ANHL12P1
Secondary IDs NCI-2013-02167, s14-01970, COG-ANHL12P1
Clinicaltrials.gov ID NCT01979536