Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype
4 other identifiers
interventional
94
2 countries
281
Brief Summary
This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2016
Longer than P75 for phase_3
281 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedStudy Start
First participant enrolled
October 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedResults Posted
Study results publicly available
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2026
ExpectedMay 4, 2026
December 1, 2025
7.7 years
May 11, 2015
March 31, 2025
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
24-month Progression-free Survival (PFS), Defined as the Proportion of Patients Who Are Alive and Progression-free 2 Years From Randomization
Will be assessed using the Lugano classification.
Time between registration and disease progression or death, whichever comes first, assessed at 24 months
Secondary Outcomes (7)
Overall Survival (OS)
The time between randomization and death from any cause, assessed up to 5 years (60 months)
Time to Hematopoietic Engraftment
First day of one week without platelet transfusion, assessed up to 5 years
PFS
Time between registration and disease progression or death, whichever comes first, assessed up to 5 years (60 months)
Response Rate Using the Lugano Classification
Up to 60 months
Treatment-related Mortality
Up to 60 months
- +2 more secondary outcomes
Other Outcomes (6)
Fludeoxyglucose Positron Emission Tomography (FDG-PET) Imaging Results
Baseline
GSTT1 Null Allele Expression
Baseline
Single-nuclear Polymorphisms (SNPs) in the BCNU Metabolism or Damage Repair Pathways
Baseline
- +3 more other outcomes
Study Arms (2)
Arm I (ibrutinib, chemotherapy, autoHCT)
EXPERIMENTALCONDITIONING REGIMEN: Investigators may choose to use either the BEAMi or CBVi regimen. BEAMi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV BID over 1-2 hours and cytarabine IV BID over 1-2 hours on days -5 to -2, and melphalan IV over 20-30 minutes on day -1. CBVi: Patients receive ibrutinib PO on days -6 to -1 or days -7 to -2 if a day of rest is planned, carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. TRANSPLANT: In both arms, patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0. CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive ibrutinib PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
Arm II (placebo, chemotherapy, autoHCT)
PLACEBO COMPARATORCONDITIONING REGIMEN: Patients receive placebo PO on days -6 to -1 and receive 1 of the 2 conditioning regimens as in Arm I. TRANSPLANT: Patients undergo autologous hematopoietic progenitor cell or bone marrow transplant on day 0. CONTINUATION REGIMEN: Beginning 30-60 days after transplant, patients receive placebo PO on days 1-28. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover Arm I.
Interventions
Undergo autologous hematopoietic progenitor cells or bone marrow transplant
Given IV
Given IV
Given IV
Given IV
Given IV
Correlative studies
Undergo autologous hematopoietic progenitor cells or bone marrow transplant
Given PO
Correlative studies
Eligibility Criteria
You may qualify if:
- PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)
- Patients must have paraffin tissue from the diagnostic or relapse biopsy available to be submitted for central pathology review; this review is mandatory prior to registration to confirm eligibility and should be initiated as soon as possible
- ELIGIBILITY CRITERIA (STEP 1)
- Diagnosis of World Health Organization (WHO) diffuse large B-cell lymphoma, non-GCB by central review confirmation
- Patient must be deemed eligible to proceed with high-dose chemotherapy and autologous stem cell transplantation by local transplant center
- New York Heart Association class I or less; ordinary physical activity does not cause undue fatigue, palpitations, dyspnea, or angina pain; patients 60 years or older must have a left ventricular ejection fraction (LVEF) at rest \>= 40% measured by echocardiogram or multi-gated acquisition (MUGA)
- Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards)
- Forced expiratory volume in 1 second (FEV1) \>= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards)
- Forced vital capacity (FVC) \>= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards)
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilbert's syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN)
- Creatinine =\< 2.0 mg/dL OR creatinine clearance (calculated clearance permitted) \>= 40 mL/min by Cockcroft-Gault formula
- Prothrombin time (PT)/ international normalized ration (INR) \< 1.5 x ULN and partial thromboplastin time (PTT) (activated \[a\]PTT) \< 1.5 x ULN
- Patient must have progressed or be refractory to prior anthracycline-containing chemotherapy (e.g. rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone \[R-CHOP\], dose adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab \[DA-EPOCH-R\], etc)
- No more than 3 prior regimens for large cell component (e.g. one induction and two salvage therapies); monoclonal antibody alone or involved field/involved site radiotherapy do not count as lines of therapy. Prior CART therapy is allowed and counts as one line of therapy
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (281)
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska, 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska, 99508, United States
Katmai Oncology Group
Anchorage, Alaska, 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
UCSF Medical Center-Parnassus
San Francisco, California, 94143, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
National Jewish Health-Main Campus
Denver, Colorado, 80206, United States
The Women's Imaging Center
Denver, Colorado, 80209, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501, United States
Grand Valley Oncology
Grand Junction, Colorado, 81505, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado, 80026, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University
New Haven, Connecticut, 06520, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware, 19973, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, 66502, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806, United States
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, 70809, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Simonds-Sinon Regional Cancer Center
Fitchburg, Massachusetts, 01420, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009, United States
Beacon Kalamazoo
Kalamazoo, Michigan, 49048, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Community Medical Center
Missoula, Montana, 59804, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
Upstate Cancer Center at Oswego
Oswego, New York, 13126, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015, United States
Bay Area Hospital
Coos Bay, Oregon, 97420, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, 17870, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, 37067, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Farmington Health Center
Farmington, Utah, 84025, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Riverton Hospital
Riverton, Utah, 84065, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
South Jordan Health Center
South Jordan, Utah, 84009, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503, United States
PeaceHealth Saint John Medical Center
Longview, Washington, 98632, United States
Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Kaiser Permanente Washington
Seattle, Washington, 98112, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington, 99204, United States
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane, Washington, 99218, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley, Washington, 99216, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, 54937, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211, Saudi Arabia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Charalambos Andreadis
- Organization
- University of California
Study Officials
- PRINCIPAL INVESTIGATOR
Charalambos B Andreadis
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 13, 2015
Study Start
October 12, 2016
Primary Completion
June 10, 2024
Study Completion (Estimated)
December 23, 2026
Last Updated
May 4, 2026
Results First Posted
September 30, 2025
Record last verified: 2025-12