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NCT00792948Active, not recruitingPhase 2

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study)

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. 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 more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
97 (actual)
First submitted
16 Nov 2008
Start date
1 Sept 2009
Primary completion date
1 Jun 2016
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT00792948

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 97
  • From 1 Sept 2009 to the primary completion date, 1 Jun 2016
  • 157 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • INDUCTION/CONSOLIDATION REGISTRATION:
  • Patients must have a morphologic diagnosis of acute lymphoblastic leukemia (ALL), with evidence of ALL involvement in bone marrow and/or blood; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible; patients with M0 acute myeloid leukemia (AML) or mixed lineage leukemia are not eligible for this study; patients with L3 (Burkitts) are also not eligible
    • For ALL in marrow or peripheral blood, immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T-cell, or mixed B/T cell); NOTE: appropriate marker studies including cluster of differentiation (CD)19 (B cell), CD10, CD5, and CD7 (T cell) must be performed; co-expression of myeloid antigens (CD13 and CD33) will not exclude patients; if possible, the lineage specific markers cytoplasmic CD22 or CD79a (B cells), cytoplasmic CD3 (T cells) and cytoplasmic myeloperoxidase (MPO) (myeloid cells) must be determined
  • Patients may have received no more than one course of remission induction therapy for ALL; patients who have received any post-remission therapy for ALL or who have relapsed from complete remission are not eligible; (patients with previously untreated ALL can be eligible, and patients who have received one course of remission induction therapy for ALL can be eligible, regardless of their response to therapy); patients may have received no more than 14 days of tyrosine kinase inhibitor therapy prior to registration; any prior induction chemotherapy must have been completed no more than 28 days prior to registration
    • NOTE: If the patient has been initiated on the protocol defined regimen (i.e. the hyper-CVAD regimen without a tyrosine kinase inhibitor) before the Philadelphia chromosome (Ph)/BCR-ABL status was known, the patient may be registered on the protocol and start dasatinib; in this first course, dasatinib will be administered up to day 14 (i.e. if the patient is registered on day 5 and starts therapy on day 6, only 8 days of dasatinib will be administered and dasatinib will be completed on day 14)
  • For patients who have received any prior therapy that was NOT remission induction therapy, one of the following must be true:
    • At least 6 weeks must have elapsed since any monoclonal antibodies were given, at least 7 days must have elapsed since any other treatment was given, and all toxicities of the remission induction therapy must have resolved to grade =\< 2
    • The patient must have rapidly progressive disease (per institutional guidelines)
  • For previously treated patients, the study chair must be contacted before registration, in order to determine the regimen to be given in the first course of induction/consolidation therapy, based on prior therapy
  • Patients must be Philadelphia (Ph) positive and/or BCR/ABL positive as confirmed by standard cytogenetics, fluorescent in situ hybridization (FISH), and/or polymerase chain reaction (PCR) testing performed by local laboratory; NOTE: samples will be submitted centrally for verification of results
  • Patients must have a bilirubin =\< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
  • Patients must have serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 3.0 x IULN and/or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3.0 x IULN within 14 days prior to registration; if both tests are done then both values must be =\< 3.0 x IULN
  • Patients must have a serum creatinine =\< 3.0 x IULN within 14 days prior to registration
  • Patients must not have active pericardial effusion, ascites, or pleural effusion of any grade; exception: if the effusion is suspected to be related to the leukemia, the patient may have pericardial effusion of =\< grade 2 or pleural effusion =\< grade 1
  • Patients may not have any clinically significant cardiovascular disease including the following:
    • Myocardial infarction or ventricular tachyarrhythmia within 6 months
    • Prolonged corrected QT (QTc) \>= 480 msec (Fridericia correction)
    • Ejection fraction less than institutional normal
    • Major conduction abnormality (unless a cardiac pacemaker is present)
    • Patients with any cardiopulmonary symptoms of unknown cause (e.g. shortness of breath, chest pain, etc.) should be evaluated by a baseline echocardiogram with or without stress test as needed in addition to electrocardiogram (EKG) to rule out QTc prolongation; the patient may be referred to a cardiologist at the discretion of the principal investigator; patients with underlying cardiopulmonary dysfunction should be excluded from the study
  • Patients must have Zubrod performance status of 0-2
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
  • Collection and submission of pre-treatment cytogenetic specimens must be completed within 28 days prior to registration on S0805
  • Collection and submission of pretreatment marrow and/or peripheral blood specimens for cellular and molecular studies, including verification of BCR/ABL status must be completed within 28 days prior to registration
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must not have prior history of known type I hypersensitivity or anaphylactic reactions to doxorubicin
  • Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
  • MAINTENANCE/INTENSIFICATION:
  • Patient must have achieved CR or CRi within 2 courses of Induction/Consolidation Chemotherapy; patient must remain in CR or CRi until beginning Maintenance Chemotherapy and this must be re-documented by bone marrow and peripheral blood examination within 28 days prior to registration to Step 2
  • All treatment related toxicities must have resolved to =\< grade 2
  • Patients must not have received allogeneic stem cell transplant
  • TRANSPLANT REGISTRATION:
  • Patients must have an available completely matched sibling donor or a 10/10 matched non-sibling donor
  • Patients must have allogeneic stem cell transplant arranged prior to registration to Step 3
  • Patients must have documented CR or CRi within 14 days prior to registration to Step 3
  • Patients must not be HIV + (human immunodeficiency virus); a negative HIV test must be obtained within 14 days prior to registration
  • POST TRANSPLANT/POST-MAINTENANCE SINGLE-AGENT DASATINIB THERAPY:
  • Patients must have reached day 100 post transplant or must have completed protocol maintenance/intensification (or must have been approved by the Study Chair after early removal from maintenance/intensification)
  • Patients must be in CR or CRi based on bone marrow and peripheral blood examination within 28 days prior to registration to Step 4
  • Patients must have recovered to =\< grade 2 from all treatment related toxicity

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (157)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
American Fork Hospital / Huntsman Intermountain Cancer Center
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American ForkUnited StatesUnknown status
Cancer Care Center at Island Hospital
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AnacortesUnited StatesUnknown status
University of Michigan Rogel Cancer Center
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Ann ArborUnited StatesUnknown status
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesUnknown status
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesUnknown status
Johns Hopkins University/Sidney Kimmel Cancer Center
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BaltimoreUnited StatesUnknown status
Hematology/Oncology Clinic PLLC
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Baton RougeUnited StatesUnknown status
Bronson Battle Creek
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Battle CreekUnited StatesUnknown status
Franciscan Saint Francis Health-Beech Grove
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Beech GroveUnited StatesUnknown status
PeaceHealth Saint Joseph Medical Center
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BellinghamUnited StatesUnknown status
MacNeal Hospital and Cancer Center
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BerwynUnited StatesUnknown status
Spectrum Health Big Rapids Hospital
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Big RapidsUnited StatesUnknown status
Montana Cancer Consortium NCORP
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BillingsUnited StatesUnknown status
Saint Vincent Healthcare
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BillingsUnited StatesUnknown status
Billings Clinic Cancer Center
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BillingsUnited StatesUnknown status
Saint Vincent Frontier Cancer Center
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BillingsUnited StatesUnknown status
Bozeman Health Deaconess Hospital
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BozemanUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
Saint Anne Hospital
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BurienUnited StatesUnknown status
Saint James Community Hospital and Cancer Treatment Center
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ButteUnited StatesUnknown status
Rocky Mountain Oncology
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CasperUnited StatesUnknown status
Sandra L Maxwell Cancer Center
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Cedar CityUnited StatesUnknown status
Cancer Center of Kansas - Chanute
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ChanuteUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Hematology and Oncology Associates
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ChicagoUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
The Jewish Hospital
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CincinnatiUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Case Western Reserve University
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ClevelandUnited StatesUnknown status
Baylor University Medical Center
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DallasUnited StatesUnknown status
Grandview Hospital
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DaytonUnited StatesUnknown status
Good Samaritan Hospital - Dayton
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DaytonUnited StatesUnknown status
Dayton NCI Community Oncology Research Program
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DaytonUnited StatesUnknown status
Miami Valley Hospital
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DaytonUnited StatesUnknown status
Miami Valley Hospital North
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DaytonUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Cancer Center of Kansas - Dodge City
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Dodge CityUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesUnknown status
Cancer Center of Kansas - El Dorado
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El DoradoUnited StatesUnknown status
Blanchard Valley Hospital
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FindlayUnited StatesUnknown status
Cancer Center of Kansas - Fort Scott
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Fort ScottUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology Inc-Parkview
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Fort WayneUnited StatesUnknown status
Atrium Medical Center-Middletown Regional Hospital
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FranklinUnited StatesUnknown status
UF Health Cancer Institute - Gainesville
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GainesvilleUnited StatesUnknown status
Trinity Health Grand Rapids Hospital
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Grand RapidsUnited StatesUnknown status
Cancer Research Consortium of West Michigan NCORP
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Grand RapidsUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesUnknown status
Great Falls Clinic
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Great FallsUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Wayne Hospital
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GreenvilleUnited StatesUnknown status
HaysMed
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HaysUnited StatesUnknown status
Saint Peter's Community Hospital
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HelenaUnited StatesUnknown status
Penn State Milton S. Hershey Medical Center
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HersheyUnited StatesUnknown status
Hematology Oncology Associates of Illinois-Highland Park
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Highland ParkUnited StatesUnknown status
UT MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Hutchinson Regional Medical Center
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HutchinsonUnited StatesUnknown status
Cancer Center of Kansas-Independence
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IndependenceUnited StatesUnknown status
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesUnknown status
Logan Health Medical Center
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KalispellUnited StatesUnknown status
Glacier Oncology PLLC
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KalispellUnited StatesUnknown status
Presence Saint Mary's Hospital
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KankakeeUnited StatesUnknown status
University of Kansas Cancer Center - North
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Kansas CityUnited StatesUnknown status
University of Kansas Cancer Center-West
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Kansas CityUnited StatesUnknown status
The University of Kansas Cancer Center-South
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Kansas CityUnited StatesUnknown status
University Health Truman Medical Center
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Kansas CityUnited StatesUnknown status
University of Kansas Cancer Center
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Kansas CityUnited StatesUnknown status
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesUnknown status
Kettering Medical Center
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KetteringUnited StatesUnknown status
Cancer Center of Kansas-Kingman
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KingmanUnited StatesUnknown status
Lawrence Memorial Hospital
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LawrenceUnited StatesUnknown status
University of Kansas Cancer Center - Lee's Summit
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Lee's SummitUnited StatesUnknown status
Lewistown Hospital
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LewistownUnited StatesUnknown status
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesUnknown status
Southwest Medical Center
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LiberalUnited StatesUnknown status
Cancer Center of Kansas-Liberal
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LiberalUnited StatesUnknown status
AMG Libertyville - Oncology
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LibertyvilleUnited StatesUnknown status
Saint Rita's Medical Center
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LimaUnited StatesUnknown status
Logan Regional Hospital
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LoganUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Cancer Center of Kansas - McPherson
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McPhersonUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Montana Cancer Specialists
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MissoulaUnited StatesUnknown status
Saint Patrick Hospital - Community Hospital
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MissoulaUnited StatesUnknown status
West Virginia University Healthcare
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MorgantownUnited StatesUnknown status
Skagit Valley Hospital
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Mount VernonUnited StatesUnknown status
Intermountain Medical Center
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MurrayUnited StatesUnknown status
Trinity Health Muskegon Hospital
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MuskegonUnited StatesUnknown status
DuPage Medical Group-Ogden
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NapervilleUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesUnknown status
Tulane University School of Medicine
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New OrleansUnited StatesUnknown status
Cancer Center of Kansas - Newton
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NewtonUnited StatesUnknown status
Illinois Cancer Specialists-Niles
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NilesUnited StatesUnknown status
McKay-Dee Hospital Center
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OgdenUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
AdventHealth Orlando
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OrlandoUnited StatesUnknown status
University of Kansas Cancer Center-Overland Park
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Overland ParkUnited StatesUnknown status
Stanford Cancer Institute Palo Alto
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Palo AltoUnited StatesUnknown status
Cancer Center of Kansas - Parsons
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ParsonsUnited StatesUnknown status
University of Pennsylvania/Abramson Cancer Center
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PhiladelphiaUnited StatesUnknown status
Mercy Hospital Pittsburg
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PittsburgUnited StatesUnknown status
Harrison HealthPartners Hematology and Oncology-Poulsbo
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PoulsboUnited StatesUnknown status
Cancer Center of Kansas - Pratt
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PrattUnited StatesUnknown status
Utah Valley Regional Medical Center
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ProvoUnited StatesUnknown status
Reid Health
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RichmondUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Cancer Center of Kansas - Salina
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SalinaUnited StatesUnknown status
Salina Regional Health Center
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SalinaUnited StatesUnknown status
Utah Cancer Specialists-Salt Lake City
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Salt Lake CityUnited StatesUnknown status
LDS Hospital
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Salt Lake CityUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesUnknown status
Swedish Medical Center-First Hill
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SeattleUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
University of Washington Medical Center - Montlake
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SeattleUnited StatesUnknown status
Kaiser Permanente Washington
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SeattleUnited StatesUnknown status
Harborview Medical Center
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SeattleUnited StatesUnknown status
Minor and James Medical PLLC
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SeattleUnited StatesUnknown status
PeaceHealth United General Medical Center
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Sedro-WoolleyUnited StatesUnknown status
Welch Cancer Center
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SheridanUnited StatesUnknown status
LSU Health Sciences Center at Shreveport
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ShreveportUnited StatesUnknown status
Saint Joseph Medical Center Hematology and Oncology - Silverdale
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SilverdaleUnited StatesUnknown status
Mercy Medical Center-Sioux City
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Sioux CityUnited StatesUnknown status
Siouxland Regional Cancer Center
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Sioux CityUnited StatesUnknown status
Saint Luke's Regional Medical Center
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Sioux CityUnited StatesUnknown status
Avera McKennan Hospital and University Health Center
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Sioux FallsUnited StatesUnknown status
Avera Cancer Institute
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Sioux FallsUnited StatesUnknown status
Hematology Oncology Associates of Illinois - Skokie
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SkokieUnited StatesUnknown status
Cancer Care Northwest - Spokane South
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SpokaneUnited StatesUnknown status
Evergreen Hematology and Oncology PS
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SpokaneUnited StatesUnknown status
Springfield Memorial Hospital
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SpringfieldUnited StatesUnknown status
Mount Nittany Medical Center
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State CollegeUnited StatesUnknown status
Saint George Regional Medical Center
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St. GeorgeUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
SSM Health Saint Louis University Hospital
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St LouisUnited StatesUnknown status
Montefiore Medical Center-Weiler Hospital
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The BronxUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesUnknown status
University of Kansas Health System Saint Francis Campus
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TopekaUnited StatesUnknown status
Munson Medical Center
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Traverse CityUnited StatesUnknown status
Upper Valley Medical Center
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TroyUnited StatesUnknown status
University of Arizona Cancer Center-North Campus
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TucsonUnited StatesUnknown status
Banner University Medical Center - Tucson
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TucsonUnited StatesUnknown status
Cancer Center of Kansas - Wellington
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WellingtonUnited StatesUnknown status
Wenatchee Valley Hospital and Clinics
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WenatcheeUnited StatesUnknown status
Wesley Medical Center
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WichitaUnited StatesUnknown status
Cancer Center of Kansas - Wichita
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WichitaUnited StatesUnknown status
Associates In Womens Health
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WichitaUnited StatesUnknown status
Ascension Via Christi Hospitals Wichita
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WichitaUnited StatesUnknown status
Wichita NCI Community Oncology Research Program
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WichitaUnited StatesUnknown status
Cancer Center of Kansas-Wichita Medical Arts Tower
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WichitaUnited StatesUnknown status
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
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WilmingtonUnited StatesUnknown status
Cancer Center of Kansas - Winfield
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WinfieldUnited StatesUnknown status
University of Michigan Health - West
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WyomingUnited StatesUnknown status
Greene Memorial Hospital
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XeniaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.