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NCT06724237RecruitingPhase 3

Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy

A Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients With Peripheral T Cell Lymphoma That Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
294 (estimated)
First submitted
5 Nov 2024
Start date
18 Jun 2025
Primary completion date
30 Apr 2074
Lead sponsor
Eastern Cooperative Oncology Group
NCT number
NCT06724237

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 294
  • From 18 Jun 2025 to the primary completion date, 30 Apr 2074
  • 165 sites in 2 countries
  • 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

  • Patient must be 18 to 75 years of age
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories:
    • Anaplastic large cell lymphoma (ALCL) ALK-negative
    • Angioimmunoblastic T-cell lymphoma (AITL)
    • Nodal PTCL with follicular helper T cell (TFH) phenotype
    • Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
  • Patient must have undergone induction treatment with an anthracycline based chemotherapy.
    • NOTE: Patients who discontinued anthracycline during treatment are eligible as long as they received at least one dose and achieved complete remission
  • Patient must have achieved radiologic complete remission following induction therapy as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT
    • NOTE: There is no central review required. Confirmation of complete remission status is determined by the enrolling institution's review
    • NOTE: If a patient had a positive bone marrow biopsy at the time of initial diagnosis (pre-induction), a repeat biopsy must be completed post induction to confirm complete remission (CR)
  • Patient must be eligible for high dose chemotherapy and autologous stem cell transplant (ASCT) per the enrolling institutional guidelines at the transplant center and be ready to proceed with ASCT if randomized to the ASCT arm
  • Patient must not have active infection requiring intravenous systemic antimicrobial at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to randomization
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse during the treatment phase of the study and thereafter according to institutional guidelines
  • Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol randomization)
  • Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x institutional ULN (obtained ≤ 14 days prior to protocol randomization)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (165)

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

SiteCityCountrySite status
Instituto Nacional De Cancerologia de Mexico
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Mexico CityMexicoRecruiting
Providence Regional Cancer System-Aberdeen
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AberdeenUnited StatesRecruiting
Anchorage Associates in Radiation Medicine
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AnchorageUnited StatesRecruiting
Alaska Breast Care and Surgery LLC
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AnchorageUnited StatesRecruiting
Katmai Oncology Group
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AnchorageUnited StatesRecruiting
Providence Alaska Medical Center
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AnchorageUnited StatesRecruiting
Alaska Women's Cancer Care
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AnchorageUnited StatesRecruiting
Alaska Oncology and Hematology LLC
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AnchorageUnited StatesRecruiting
OhioHealth O'Bleness Hospital
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AthensUnited StatesRecruiting
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesRecruiting
Rocky Mountain Cancer Centers-Aurora
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AuroraUnited StatesActive, not recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
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BaltimoreUnited StatesRecruiting
PeaceHealth Saint Joseph Medical Center
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BellinghamUnited StatesRecruiting
Saint Charles Health System
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BendUnited StatesRecruiting
University of Alabama at Birmingham Cancer Center
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BirminghamUnited StatesNot yet recruiting
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesRecruiting
Boulder Community Foothills Hospital
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BoulderUnited StatesActive, not recruiting
Rocky Mountain Cancer Centers-Boulder
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BoulderUnited StatesActive, not recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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BurbankUnited StatesRecruiting
Loyola Center for Health at Burr Ridge
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Burr RidgeUnited StatesRecruiting
Rocky Mountain Cancer Centers - Centennial
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CentennialUnited StatesActive, not recruiting
Providence Regional Cancer System-Centralia
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CentraliaUnited StatesRecruiting
Christiana Care Health System-Concord Health Center
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Chadds FordUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Novant Health Presbyterian Medical Center
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CharlotteUnited StatesRecruiting
Carolinas Medical Center/Levine Cancer Institute
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CharlotteUnited StatesRecruiting
University of Virginia Cancer Center
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CharlottesvilleUnited StatesRecruiting
Siteman Cancer Center at Saint Peters Hospital
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City of Saint PetersUnited StatesRecruiting
Clackamas Radiation Oncology Center
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ClackamasUnited StatesRecruiting
Wake Forest University at Clemmons
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ClemmonsUnited StatesRecruiting
Columbus Oncology and Hematology Associates Inc
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ColumbusUnited StatesRecruiting
Riverside Methodist Hospital
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ColumbusUnited StatesRecruiting
Doctors Hospital
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ColumbusUnited StatesRecruiting
Grant Medical Center
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ColumbusUnited StatesRecruiting
Bay Area Hospital
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Coos BayUnited StatesRecruiting
Siteman Cancer Center at West County Hospital
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Creve CoeurUnited StatesRecruiting
Geisinger Medical Center
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DanvilleUnited StatesRecruiting
Delaware Health Center-Grady Cancer Center
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DelawareUnited StatesRecruiting
Grady Memorial Hospital
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DelawareUnited StatesRecruiting
Rocky Mountain Cancer Centers-Rose
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DenverUnited StatesActive, not recruiting
Rocky Mountain Cancer Centers-Midtown
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DenverUnited StatesActive, not recruiting
Presbyterian - Saint Lukes Medical Center - Health One
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DenverUnited StatesActive, not recruiting
The Women's Imaging Center
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DenverUnited StatesActive, not recruiting
Colorado Blood Cancer Institute
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DenverUnited StatesActive, not recruiting
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesRecruiting
Dublin Methodist Hospital
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DublinUnited StatesRecruiting
Columbus Oncology and Hematology Associates
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DublinUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Swedish Cancer Institute-Edmonds
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EdmondsUnited StatesRecruiting
Christiana Care - Union Hospital
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ElktonUnited StatesRecruiting
The Melanoma and Skin Cancer Institute
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EnglewoodUnited StatesActive, not recruiting
Rocky Mountain Cancer Centers - Swedish
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EnglewoodUnited StatesActive, not recruiting
Providence Regional Cancer Partnership
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EverettUnited StatesRecruiting
Fairbanks Memorial Hospital
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FairbanksUnited StatesActive, not recruiting
Weisberg Cancer Treatment Center
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Farmington HillsUnited StatesRecruiting
Saint Luke's Cancer Institute - Fruitland
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FruitlandUnited StatesRecruiting
Loyola Medicine Homer Glen
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Homer GlenUnited StatesRecruiting
Providence Hood River Memorial Hospital
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Hood RiverUnited StatesRecruiting
Novant Health Presbyterian Medical Center Huntersville
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HuntersvilleUnited StatesRecruiting
Novant Health Cancer Institute - Huntersville
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HuntersvilleUnited StatesRecruiting
Indiana University/Melvin and Bren Simon Cancer Center
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IndianapolisUnited StatesRecruiting
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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IrvineUnited StatesRecruiting
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesRecruiting
Mayo Clinic in Florida
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JacksonvilleUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - Briarcliff
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - North
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Kansas CityUnited StatesRecruiting
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesRecruiting
Novant Health Cancer Institute - Kernersville
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KernersvilleUnited StatesRecruiting
Providence Regional Cancer System-Lacey
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LaceyUnited StatesRecruiting
Rocky Mountain Cancer Centers-Lakewood
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LakewoodUnited StatesActive, not recruiting
University of Kansas Cancer Center - Lee's Summit
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Lee's SummitUnited StatesRecruiting
Beebe Medical Center
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LewesUnited StatesRecruiting
Rocky Mountain Cancer Centers-Littleton
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LittletonUnited StatesActive, not recruiting
Rocky Mountain Cancer Centers-Sky Ridge
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Lone TreeUnited StatesActive, not recruiting
Rocky Mountain Cancer Centers-Longmont
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LongmontUnited StatesActive, not recruiting
PeaceHealth Saint John Medical Center
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LongviewUnited StatesRecruiting
UofL Health Medical Center Northeast
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LouisvilleUnited StatesRecruiting
The James Graham Brown Cancer Center at University of Louisville
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LouisvilleUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
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MadisonUnited StatesRecruiting
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesRecruiting
OhioHealth Mansfield Hospital
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MansfieldUnited StatesRecruiting
OhioHealth Marion General Hospital
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MarionUnited StatesRecruiting
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesRecruiting
Contra Costa Regional Medical Center
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MartinezUnited StatesActive, not recruiting
Novant Health Cancer Institute - Matthews
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MatthewsUnited StatesRecruiting
Matthews Radiation Oncology Center
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MatthewsUnited StatesRecruiting
Loyola University Medical Center
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MaywoodUnited StatesRecruiting
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Melrose ParkUnited StatesRecruiting
Froedtert Menomonee Falls Hospital
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Menomonee FallsUnited StatesRecruiting
Saint Luke's Cancer Institute - Meridian
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MeridianUnited StatesRecruiting
Beebe South Coastal Health Campus
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MillvilleUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Saint Patrick Hospital - Community Hospital
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MissoulaUnited StatesRecruiting
Novant Health Cancer Institute - Mooresville
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MooresvilleUnited StatesRecruiting
Novant Health Cancer Institute - Mount Airy
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Mount AiryUnited StatesRecruiting
Skagit Regional Health Cancer Care Center
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Mount VernonUnited StatesRecruiting
ProHealth D N Greenwald Center
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MukwonagoUnited StatesRecruiting
Saint Luke's Cancer Institute - Nampa
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NampaUnited StatesRecruiting
Providence Queen of The Valley
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NapaUnited StatesRecruiting
Christiana Care Health System-Christiana Hospital
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NewarkUnited StatesRecruiting
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesRecruiting
Helen F Graham Cancer Center
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NewarkUnited StatesRecruiting
Providence Newberg Medical Center
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NewbergUnited StatesRecruiting
Froedtert and MCW Moorland Reserve Health Center
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New BerlinUnited StatesRecruiting
Ochsner Medical Center Jefferson
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New OrleansUnited StatesRecruiting
Novant Health Cancer Institute - Wilkesboro
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North WilkesboroUnited StatesRecruiting
Drexel Town Square Health Center
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Oak CreekUnited StatesRecruiting
ProHealth Oconomowoc Memorial Hospital
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OconomowocUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesRecruiting
University of Kansas Cancer Center-Overland Park
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Overland ParkUnited StatesRecruiting
Mercy Health - Paducah Cancer Center
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PaducahUnited StatesActive, not recruiting
Mayo Clinic Hospital in Arizona
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PhoenixUnited StatesRecruiting
OhioHealth Pickerington Methodist Hospital
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PickeringtonUnited StatesRecruiting
Providence Saint Vincent Medical Center
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PortlandUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesSuspended
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Jefferson Healthcare
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Port TownsendUnited StatesActive, not recruiting
Saint Charles Health System-Redmond
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RedmondUnited StatesRecruiting
Beebe Health Campus
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Rehoboth BeachUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
Mayo Clinic in Rochester
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RochesterUnited StatesRecruiting
University of Rochester
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RochesterUnited StatesRecruiting
Rowan Regional Medical Center
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SalisburyUnited StatesRecruiting
Huntsman Cancer Institute/University of Utah
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Salt Lake CityUnited StatesRecruiting
Providence Medical Foundation - Santa Rosa
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Santa RosaUnited StatesRecruiting
Providence Santa Rosa Memorial Hospital
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Santa RosaUnited StatesRecruiting
Swedish Medical Center-Cherry Hill
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SeattleUnited StatesRecruiting
Swedish Medical Center-First Hill
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SeattleUnited StatesRecruiting
Swedish Medical Center-Ballard Campus
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SeattleUnited StatesRecruiting
PeaceHealth United General Medical Center
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Sedro-WoolleyUnited StatesRecruiting
LSU Health Sciences Center at Shreveport
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ShreveportUnited StatesRecruiting
Cancer Care Northwest - Spokane South
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SpokaneUnited StatesRecruiting
Cancer Care Northwest-North Spokane
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SpokaneUnited StatesRecruiting
Cancer Care Northwest-Valley
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SpokaneUnited StatesRecruiting
Novant Health Cancer Institute - Statesville
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StatevilleUnited StatesRecruiting
Siteman Cancer Center at Christian Hospital
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St LouisUnited StatesRecruiting
Siteman Cancer Center-South County
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St LouisUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Moffitt Cancer Center-International Plaza
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TampaUnited StatesRecruiting
Moffitt Cancer Center - McKinley Campus
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TampaUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesRecruiting
Novant Health Cancer Institute - Thomasville
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ThomasvilleUnited StatesRecruiting
Rocky Mountain Cancer Centers-Thornton
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ThorntonUnited StatesActive, not recruiting
Banner University Medical Center - Tucson
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TucsonUnited StatesRecruiting
University of Arizona Cancer Center-North Campus
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TucsonUnited StatesRecruiting
Saint Luke's Cancer Institute - Twin Falls
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Twin FallsUnited StatesRecruiting
PeaceHealth Southwest Medical Center
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VancouverUnited StatesRecruiting
Providence Saint Mary Regional Cancer Center
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Walla WallaUnited StatesRecruiting
BASS Medical Group - Lennon
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Walnut CreekUnited StatesActive, not recruiting
Sibley Memorial Hospital
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Washington D.C.United StatesRecruiting
UW Cancer Center at ProHealth Care
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WaukeshaUnited StatesRecruiting
ProHealth Waukesha Memorial Hospital
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WaukeshaUnited StatesRecruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
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West BendUnited StatesRecruiting
OhioHealth Westerville Medical Campus/Westerville Cancer Center
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WestervilleUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Geisinger Wyoming Valley/Henry Cancer Center
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Wilkes-BarreUnited StatesRecruiting
Christiana Care Health System-Wilmington Hospital
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WilmingtonUnited StatesRecruiting
Novant Health Forsyth Medical Center
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Winston-SalemUnited StatesRecruiting
Wake Forest University Health Sciences
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Winston-SalemUnited StatesRecruiting

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