Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients with Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma
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. 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 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 (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
- 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 due to the amount of methotrexate and potential for side effects
- 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
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 205-638-9285
Email: oncologyresearch@peds.uab.edu
Arizona
Phoenix
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 602-546-0920
Arkansas
Little Rock
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 501-364-7373
California
Downey
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 626-564-3455
Duarte
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-826-4673
Email: becomingapatient@coh.org
Loma Linda
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 909-558-3375
Los Angeles
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 310-423-8965
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 323-361-4110
Madera
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 559-353-3000
Email: Research@valleychildrens.org
Oakland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 510-428-3324
Email: cgolden@mail.cho.org
Orange
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 714-997-3000
Palo Alto
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-694-0012
Email: ccto-office@stanford.edu
Sacramento
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-734-3089
San Diego
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 619-532-8712
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 858-966-5934
San Francisco
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-827-3222
Colorado
Aurora
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-764-5056
Email: josh.b.gordon@nsmtp.kp.org
Denver
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 303-839-6000
Connecticut
Hartford
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 860-545-9981
New Haven
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Delaware
Wilmington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-651-6884
Email: dperry@nemours.org
District of Columbia
Washington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 202-884-2549
Florida
Fort Myers
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 239-343-5333
Email: molly.arnstrom@leehealth.org
Gainesville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 352-273-8010
Email: cancer-center@ufl.edu
Jacksonville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 904-697-3529
Miami
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-624-2778
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 407-303-2090
Email: FH.Cancer.Research@flhosp.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 321-843-2584
Email: melissa.leffin@orlandohealth.com
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 407-650-7150
Saint Petersburg
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 727-767-4784
Email: Ashley.Repp@jhmi.edu
Tampa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 813-356-7168
Email: Katelynn.Colgain@baycare.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 813-844-7829
Email: syapchanyk@tgh.org
West Palm Beach
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 561-881-2815
Georgia
Atlanta
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 404-785-2025
Email: Leann.Schilling@choa.org
Augusta
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 706-721-2388
Email: ga_cares@augusta.edu
Savannah
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 912-350-7887
Email: clayter1@memorialhealth.com
Idaho
Boise
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org
Illinois
Chicago
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-880-4562
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-355-3046
Oak Lawn
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 847-723-7570
Peoria
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-226-4343
Springfield
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-545-7929
Indiana
Indianapolis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-248-1199
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 317-338-2194
Email: research@stvincent.org
Iowa
Des Moines
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 515-241-8912
Email: samantha.mallory@unitypoint.org
Iowa City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-237-1225
Kentucky
Lexington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 502-629-5500
Email: CancerResource@nortonhealthcare.org
Louisiana
New Orleans
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: CHResearch@lcmchealth.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org
Maine
Scarborough
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 207-396-7581
Email: sverwys@mmc.org
Maryland
Baltimore
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 410-955-8804
Email: jhcccro@jhmi.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 410-601-6120
Email: pridgely@lifebridgehealth.org
Massachusetts
Boston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-442-3324
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-726-5130
Michigan
Detroit
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
East Lansing
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 517-975-9547
Grand Rapids
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Royal Oak
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-551-7695
Minnesota
Minneapolis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 612-813-5193
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 612-624-2620
Rochester
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 855-776-0015
Mississippi
Jackson
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 601-815-6700
Missouri
Columbia
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Kansas City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 816-302-6808
Email: rryan@cmh.edu
Saint Louis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-251-7066
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Nebraska
Omaha
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 402-955-3949
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu
Nevada
Las Vegas
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
New Hampshire
Lebanon
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu
New Jersey
Hackensack
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 201-996-2879
Morristown
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 973-971-5900
New Brunswick
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 732-235-8675
Newark
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 973-926-7230
Paterson
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 973-754-2207
Email: HallL@sjhmc.org
New York
Albany
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 518-262-5513
Bronx
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-379-6866
Email: aaraiza@montefiore.org
Buffalo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
Mineola
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 516-663-3115
New Hyde Park
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 718-470-3460
New York
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 212-263-4434
Email: prmc.coordinator@nyumc.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 212-746-1848
Rochester
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 585-275-5830
Syracuse
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 315-464-5476
Valhalla
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 914-594-3794
North Carolina
Asheville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 828-213-2539
Email: Karen.Smith3@HCAHealthcare.com
Chapel Hill
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Charlotte
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-804-9376
Durham
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-275-3853
Winston-Salem
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 336-713-6771
Ohio
Akron
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 330-543-3193
Cincinnati
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 513-636-2799
Email: cancer@cchmc.org
Cleveland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 216-844-5437
Columbus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-072-2657
Email: amy.yekisa@nationwidechildrens.org
Dayton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-228-4055
Toledo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-824-1842
Oklahoma
Oklahoma City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu
Oregon
Portland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-413-2560
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-494-1080
Email: trials@ohsu.edu
Pennsylvania
Hershey
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 717-531-6012
Philadelphia
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 267-425-5544
Email: CancerTrials@email.chop.edu
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 215-427-8991
Pittsburgh
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-692-8570
Email: jean.tersak@chp.edu
Rhode Island
Providence
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 401-444-1488
South Carolina
Charleston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 843-792-9321
Email: hcc-clinical-trials@musc.edu
Columbia
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 803-434-3533
Greenville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
South Dakota
Sioux Falls
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org
Tennessee
Chattanooga
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 865-331-1812
Knoxville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 865-541-8266
Memphis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-278-5833
Email: info@stjude.org
Nashville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 615-342-1919
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-811-8480
Texas
Austin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 512-628-1902
Email: TXAUS-DL-SFCHemonc.research@ascension.org
Corpus Christi
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 361-694-5311
Email: Crystal.DeLosSantos@dchstx.org
Dallas
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 972-566-5588
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
El Paso
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 915-298-5444
Email: lisa.hartman@ttuhsc.edu
Fort Worth
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 682-885-2103
Email: CookChildrensResearch@cookchildrens.org
Houston
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 713-798-1354
Email: burton@bcm.edu
San Antonio
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: helpdesk@childrensoncologygroup.org
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 210-575-6240
Email: Vinod.GidvaniDiaz@hcahealthcare.com
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 210-450-3800
Email: phoresearchoffice@uthscsa.edu
Utah
Salt Lake City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 801-585-5270
Virginia
Falls Church
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 703-208-6650
Email: Stephanie.VanBebber@inova.org
Norfolk
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 757-066-8724
Email: CCBDCresearch@chkd.org
Richmond
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 804-628-1914
Email: klcampbell@vcu.edu
Washington
Seattle
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-987-2000
Spokane
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-228-6618
Email: HopeBeginsHere@providence.org
Tacoma
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 253-968-0129
Email: mamcdci@amedd.army.mil
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 253-403-1461
Email: research@multicare.org
Wisconsin
Madison
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-622-8922
Milwaukee
Status: Temporarily closed to accrual
Contact: Site Public Contact
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
Treatment
Lead Organization
Lead Organization
Childrens Oncology Group
Principal Investigator
Eric Jeffrey Lowe
Trial IDs
Secondary IDs NCI-2013-02167, s14-01970, COG-ANHL12P1
Clinicaltrials.gov ID NCT01979536