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



Status:Suspended
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 21
Updated:2/17/2019
Start Date:November 8, 2013
End Date:December 31, 2021

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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)

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.

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.

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
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Gainesville, FL
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
Principal Investigator: Nichole L. Bryant
Phone: 864-241-6251
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, SC
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Burton E. Appel
Phone: 201-996-2879
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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Hershey, Pennsylvania 17033
Principal Investigator: Lisa M. McGregor
Phone: 717-531-6012
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Hershey, PA
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Principal Investigator: Wade T. Kyono
Phone: 808-983-6090
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Honolulu, HI
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Honolulu, Hawaii 96813
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Honolulu, HI
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Houston, Texas 77030
Principal Investigator: Kala Y. Kamdar
Phone: 713-798-1354
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Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Kamnesh R. Pradhan
Phone: 800-248-1199
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Indianapolis, Indiana 46260
Principal Investigator: Bassem I. Razzouk
Phone: 317-338-2194
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Indianapolis, IN
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Iowa City, Iowa 52242
Principal Investigator: Mariko Sato
Phone: 800-237-1225
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Iowa City, IA
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Jacksonville, Florida 32207
Principal Investigator: Emi H. Caywood
Phone: 904-697-3529
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Jacksonville, FL
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Kansas City, Missouri 64108
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Kansas City, MO
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
Principal Investigator: Ray C. Pais
Phone: 865-541-8266
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Knoxville, TN
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Las Vegas, Nevada 89109
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, NV
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Las Vegas, Nevada 89144
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, NV
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Las Vegas, Nevada 89135
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Julie Kim
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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from
Lebanon, NH
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Lexington, Kentucky
Principal Investigator: Vlad C. Radulescu
Phone: 859-257-3379
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Lexington, KY
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: David L. Becton
Phone: 501-364-7373
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Albert Kheradpour
Phone: 909-558-3375
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Loma Linda, CA
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Long Beach, California 90806
Principal Investigator: Pamela H. Kempert
Phone: 562-933-5600
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Long Beach, CA
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Louisville, Kentucky 40202
Principal Investigator: Ashok B. Raj
Phone: 866-530-5516
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Louisville, KY
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Madera, California 93638
Principal Investigator: Vonda L. Crouse
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Madera, CA
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Kenneth B. De Santes
Phone: 800-622-8922
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Madison, WI
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Miami, Florida 33155
Principal Investigator: Enrique A. Escalon
Phone: 888-624-2778
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Miami, FL
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Miami, Florida 33136
Principal Investigator: Julio C. Barredo
Phone: 305-243-2647
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Miami, FL
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Paul D. Harker-Murray
Phone: 414-955-4727
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Milwaukee, WI
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259 1st Street
Mineola, New York 11501
Principal Investigator: Mark E. Weinblatt
Phone: 866-946-8476
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Mineola, NY
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