Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer, Women's Studies, Hematology
Therapuetic Areas:Hematology, Oncology, Reproductive
Healthy:No
Age Range:Any - 29
Updated:3/9/2019
Start Date:June 20, 2011

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A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in
treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib
tosylate 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 or by stopping them from dividing. Giving bortezomib and
sorafenib tosylate together with combination chemotherapy may be an effective treatment for
acute myeloid leukemia.

PRIMARY OBJECTIVES:

I. To compare event-free survival (EFS) and overall survival (OS) in patients with de novo
acute myeloid leukemia (AML) without high allelic ratio fms-like tyrosine kinase
(FLT3)/internal tandem duplications (ITD)+ mutations who are randomized to standard therapy
versus bortezomib/standard combination therapy.

II. To determine the feasibility of combining bortezomib with standard chemotherapy in
patients with de novo AML.

III. To compare the OS and EFS of high-risk patients treated with intensive Induction II with
historical controls from AAML03P1 and AAML0531.

IV. To determine the feasibility of administering sorafenib (sorafenib tosylate) with
standard chemotherapy and in a one year maintenance phase in patients with de novo high
allelic ratio FLT3/ITD+ AML.

SECONDARY OBJECTIVES:

I. To assess the anti-leukemic activity of sorafenib in patients with de novo high allelic
ratio FLT3/ITD+ AML.

II. To compare the percentage of patients converting from positive minimal residual disease
(MRD) to negative MRD after Intensive Induction II with historical controls from AAML03P1 and
AAML0531.

III. To compare OS, disease-free survival (DFS), cumulative incidence of relapse, and
treatment-related mortality from end of Intensification I between patients allocated to best
allogenic donor stem cell transplant (SCT) and comparable patients on AAML0531 who did not
receive allogenic donor SCT.

IV. To compare OS, DFS, cumulative incidence of relapse, treatment-related mortality, and
severe toxicity between patients allocated to matched family donor SCT on AAML1031 and
AAML0531.

V. To assess the health-related quality of life (HRQOL) of patients treated with chemotherapy
and stem cell transplant (SCT) for AML.

VI. To evaluate bortezomib pharmacokinetics (PK) in patients receiving the combination
regimen.

VII. To obtain sorafenib and metabolite steady state pharmacokinetics and
pharmacokinetic-pharmacodynamic data in subjects with FLT3/ITD receiving sorafenib.

VIII. To compare the changes in shortening fraction/ejection fraction over time between
patients treated with and without dexrazoxane.

IX. To refine the use of minimal-residual disease (MRD) detection with 4-color flow
cytometry.

X. To evaluate the prognostic significance of molecular MRD and its contribution to risk
identification with multidimensional flow cytometry (MDF)-based MRD in patients with
translocations amenable to quantitative real time (RT)-polymerase chain reaction (PCR) (e.g.,
t[8;21], inv[16], t[9;11], Wilms tumor 1 [WT1] expression).

XI. To determine the leukemic involvement of the hematopoietic early progenitor cell and its
role in defining response to therapy.

XII. To define the leukemic stem cell population in patients with AML. XIII. To determine the
prevalence and prognostic significance of molecular abnormalities of WT1, runt-related
transcription factor (RUNX)1, mixed-lineage leukemia (MLL)-partial tandem duplication (PTD),
tet methylcytosine dioxygenase 2 (TET2), Cbl proto-oncogene, E3 ubiquitin protein ligase
(c-CBL), v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT), and other novel
AML-associated genes in pediatric AML.

XIV. Correlate the expression of cluster of differentiation (CD)74 antigen as well as
proteasome beta 5-subunit (PSMB5) gene expression and mutation with response to bortezomib.

XV. To evaluate the changes in protein expression and unfolded protein response (UPR) in
patients with AML.

XVI. To determine the expression level of wild-type FLT3, and correlate with outcome and in
vitro sensitivity to FLT3 inhibition.

XVII. To collect biology specimens at diagnosis, treatment time points, and relapse for
future biology studies XVIII. To create a pediatric-specific algorithm to predict the
occurrence of grade 2-4 acute graft-versus-host disease (GVHD) prior to its clinical
manifestations using a combination of pre-transplant clinical variables and serum GVHD
biomarker concentrations in the first weeks after SCT.

OUTLINE: This is a dose-escalation study of sorafenib tosylate. Patients are randomized to 1
of 2 treatment arms or offered treatment on 1 of 2 arms. (Arms A and B are closed to new
patient enrollment as of 02/04/2016)

INDUCTION I:

ARM A: Patients receive cytarabine intrathecally (IT) on day 1 and ADE chemotherapy
comprising cytarabine intravenously (IV) over 1-30 minutes on days 1-10; daunorubicin
hydrochloride IV over 1-15 minutes on days 1, 3, and 5; and etoposide IV over 1-2 hours on
days 1-5.

ARM B: Patients receive cytarabine IT and ADE chemotherapy as in Induction I, Arm A. Patients
also receive bortezomib IV over 3-5 seconds on days 1, 4, and 8.

ARM C (high-risk [HR] FLT3/ITD+ disease): Patients receive cytarabine IT and ADE chemotherapy
as in Induction I, Arm A and sorafenib tosylate orally (PO) on days 11-28.

ARM D (unknown FLT3/ITD status prior to study enrollment): Patients receive cytarabine IT and
ADE chemotherapy as in Induction I, Arm A. If patients are determined to be HR FLT3/ITD+ no
later than the end of Induction I they will be eligible to participate in Arm C.

INDUCTION II: Patients without HR FLT3/ITD+ disease begin Induction II administration on day
29.

ARM A (low-risk [LR] patients): Patients receive cytarabine IT and ADE chemotherapy as in
Induction I Arm A.

ARM A (HR patients): Patients receive cytarabine IT on day 1 and MA chemotherapy comprising
high-dose cytarabine IV over 1-3 hours on days 1-4, and mitoxantrone IV over 15-30 minutes on
days 3-6.

ARM B (LR patients): Patients receive cytarabine IT, ADE chemotherapy, and bortezomib as in
Induction I Arm B.

ARM B (HR patients): Patients receive cytarabine IT and MA chemotherapy as in Induction II,
Arm A (HR patients) and bortezomib IV on days 1, 4, and 8.

ARM C (patients with HR FLT3/ITD+ disease, cohort 3): Patients receive cytarabine IT on day
1, cytarabine IV over 1-30 minutes on days 1-8, daunorubicin hydrochloride IV over 1-15
minutes on days 1, 3, and 5, etoposide IV over 1-2 hours on days 1-5, and sorafenib tosylate
PO on days 9-36.

Patients who achieve complete remission (CR) proceed to Intensification I (beginning on day
37). Patients with refractory disease are off protocol therapy.

INTENSIFICATION I:

ARM A: Patients receive cytarabine IT on day 1 and AE chemotherapy comprising high-dose
cytarabine IV over 1-3 hours, and etoposide IV over 1-2 hours on days 1-5.

ARM B: Patients receive cytarabine IT and AE chemotherapy in Intensification II, Arm A, and
bortezomib IV on days 1, 4, and 8.

ARM C (cohort 3): Patients receive cytarabine IT and AE chemotherapy in Intensification II,
Arm A, and sorafenib tosylate PO on daily on days 6-28.

Patients who achieve CR proceed to Intensification II or stem cell transplantation (SCT)
beginning on day 34. Patients with refractory disease are off protocol therapy.

INTENSIFICATION II:

ARM A (LR): Patients receive cytarabine IT on day 1 and MA chemotherapy as in Induction II,
Arm A (HR patients).

ARM B (LR): Patients receive cytarabine IT on day 1, MA chemotherapy as in Induction II, Arm
A (HR patients), and bortezomib IV on days 1, 4, and 8.

ARMS A AND B (HR and no donor for SCT): Patients receive high-dose cytarabine IV over 3 hours
on days 1, 2, 8, and 9 and asparaginase intramuscularly (IM) on days 2 and 9.

ARM C (HR cohort 3): Patients receive cytarabine IT on day 1, MA chemotherapy as in Induction
II, Arm A (HR patients), and sorafenib tosylate PO on days 7-34.

STEM CELL TRANSPLANTATION (SCT) (HR patients with matched family [MFD] or unrelated donor):

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes once daily on
days -5 to -2 and busulfan IV over 2 hours 4 times daily on days -5 to -2.

TRANSPLANTATION: Patients undergo allogeneic SCT within 36 to 48 hours after the last dose of
busulfan.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO beginning on day -2 and
continuing until day 98 (matched sibling donor) or day 180 (with taper) (other
related/unrelated donors or cord blood) and methotrexate IV on days 1, 3, and 6 (matched
sibling/cord blood donors) or days 1, 3, 6, and 11 (other related/unrelated donors). Patients
with unrelated donors also receive antithymocyte globulin IV over 6-8 hours on days -3 to -1.

MAINTENANCE: Patients in Arm C receive sorafenib tosylate PO starting on day 40-100 after
completion of intensification II or SCT for one year.

After completion of study therapy, patients are followed up monthly for 6 months, every 2
months for 6 months, every 4 months for 1 year, every 6 months for 1 year, and then yearly
thereafter.

Inclusion Criteria:

- Patients must be newly diagnosed with de novo acute myelogenous leukemia

- Patients with previously untreated primary AML who meet the customary criteria for AML
with >= 20% bone marrow blasts as set out in the 2008 World Health Organization (WHO)
Myeloid Neoplasm Classification are eligible

- Attempts to obtain bone marrow either by aspirate or biopsy must be made unless
clinically prohibitive; in cases where it is clinically prohibitive, peripheral
blood with an excess of 20% blasts and in which adequate flow cytometric and
cytogenetics/fluorescent in situ hybridization (FISH) testing is feasible can be
substituted for the marrow exam at diagnosis

- Patients with < 20% bone marrow blasts are eligible if they have:

- A karyotypic abnormality characteristic of de novo AML (t(8;21)(q22;q22),
inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities

- The unequivocal presence of megakaryoblasts, or

- Biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including
leukemia cutis)

- Patients with any performance status are eligible for enrollment

- Prior therapy with hydroxyurea, all-trans retinoic acid (ATRA), corticosteroids (any
route), and IT cytarabine given at diagnosis is allowed; hydroxyurea and ATRA must be
discontinued prior to initiation of protocol therapy; patients who have previously
received any other chemotherapy, radiation therapy or any other antileukemic therapy
are not eligible for this protocol

Exclusion Criteria:

- Patients with any of the following constitutional conditions are not eligible:

- Fanconi anemia

- Shwachman syndrome

- Any other known bone marrow failure syndrome

- Patients with constitutional trisomy 21 or with constitutional mosaicism of
trisomy 21 Note: enrollment may occur pending results of clinically indicated
studies to exclude these conditions

- Patients with any of the following oncologic diagnoses are not eligible:

- Any concurrent malignancy

- Juvenile myelomonocytic leukemia (JMML)

- Philadelphia chromosome positive AML

- Biphenotypic or bilineal acute leukemia

- Acute promyelocytic leukemia

- Acute myeloid leukemia arising from myelodysplasia

- Therapy-related myeloid neoplasms Note: enrollment may occur pending results of
clinically indicated studies to exclude these conditions

- Pregnancy and breast feeding

- Female patients who are pregnant are ineligible

- Lactating females are not eligible unless they have agreed not to breastfeed their
infants

- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation
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Children's Hospital of Alabama Children
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3333 Burnet Avenue # Mlc3008
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Patrick A. Brown
Phone: 410-955-8804
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Sam W. Lew
Phone: 800-987-3005
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Bangor, ME
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Anne B. Warwick
Phone: 619-532-8712
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bethesda, MD
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Birmingham, AL
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Eugenia Chang
Phone: 208-381-3376
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, ID
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Boston, Massachusetts 02111
Principal Investigator: Michael J. Kelly
Phone: 617-636-5000
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Boston, MA
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Howard J. Weinstein
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Howard J. Weinstein
Phone: 877-726-5130
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Bronx, NY
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Chapel Hill, North Carolina 27599
Principal Investigator: Stuart H. Gold
Phone: 877-668-0683
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Chapel Hill, NC
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Jacqueline M. Kraveka
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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3110 MacCorkle Avenue Southeast
Charleston, West Virginia 25304
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Charleston, WV
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Charlotte, North Carolina 28204
Principal Investigator: Joel A. Kaplan
Phone: 704-355-2884
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Charlotte, NC
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Charlotte, North Carolina 28204
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Charlotte, NC
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Chattanooga, Tennessee 37403
Principal Investigator: Manoo G. Bhakta
Phone: 865-331-1812
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Chattanooga, TN
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Principal Investigator: Mary L. Schmidt
Phone: 312-355-3046
Univ of Illinois A major research university in the heart of one of the world's...
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Jennifer L. McNeer
Phone: 773-834-7424
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Chicago, IL
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Chicago, Illinois 60614
Principal Investigator: Nobuko Hijiya
Phone: 773-880-4562
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Chicago, IL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Aron Flagg
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Columbia, Missouri 65201
Principal Investigator: Barbara A. Gruner
Phone: 573-882-7440
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Columbia, MO
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Principal Investigator: Stuart L. Cramer
Phone: 205-934-0309
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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Columbia, SC
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Dallas, Texas 75390
Principal Investigator: Tamra L. Slone
Phone: 214-648-7097
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Dallas, TX
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Jagadeesh Ramdas
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Dayton, Ohio 45404
Principal Investigator: Ayman A. El-Sheikh
Phone: 800-228-4055
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Dayton, OH
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Denver, Colorado 80218
Principal Investigator: Jennifer J. Clark
Phone: 866-775-6246
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Denver, CO
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Jeffrey W. Taub
Phone: 313-576-9363
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, Michigan 48236
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9333 Imperial Highway
Downey, California 90242
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Downey, CA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Susan G. Kreissman
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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East Lansing, Michigan 48824
Principal Investigator: Renuka Gera
Phone: 517-975-9547
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East Lansing, MI
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El Paso, Texas 79905
Principal Investigator: Lisa L. Hartman
Phone: 915-298-5444
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801 Broadway North
Fargo, North Dakota 58122
Principal Investigator: Samuel O. Anim
Phone: 701-234-6161
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Fargo, ND
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Hector M. Rodriguez-Cortes
Phone: 954-355-5346
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Myers, Florida 33908
Principal Investigator: Emad K. Salman
Phone: 877-680-0008
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Kenneth M. Heym
Phone: 682-885-2103
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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1600 Southwest Archer Road
Gainesville, Florida 32610
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835 S Van Buren St
Green Bay, Wisconsin 54301
Principal Investigator: John R. Hill
Phone: 920-433-8889
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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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Hershey, Pennsylvania 17033
Principal Investigator: Lisa M. McGregor
Phone: 717-531-6012
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Hollywood, Florida 33021
Principal Investigator: Iftikhar Hanif
Phone: 954-265-2234
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Principal Investigator: Wade T. Kyono
Phone: 808-586-2979
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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Houston, Texas 77030
Principal Investigator: Michele S. Redell
Phone: 713-798-1354
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Hunter Regional Mail Centre, New South Wales
Principal Investigator: Draga Barbaric
Phone: (02) 9382-1721
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Hunter Regional Mail Centre,
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Robert J. Fallon
Phone: 800-248-1199
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, Indiana 46260
Principal Investigator: Bassem I. Razzouk
Phone: 317-338-2194
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