Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas

Who is this study for? Adult patients with diffuse large B-cell lymphoma
What treatments are being studied? Venetoclax
Status: Suspended
Location: See all (639) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This phase II/III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Pathologic diagnosis of diffuse large B-cell lymphoma (DLBCL) or high grade B-cell lymphoma (HGBCL). Eligible subtypes include DLBCL not otherwise specified (NOS), Epstein Barr Virus positive (EBV+) DLBCL, and DLBCL/HGBCL transformed from an underlying indolent B-cell lymphoma. Patients with T-cell/histiocyte rich large B-cell lymphoma and primary mediastinal B-cell lymphoma are not eligible

• Double hit lymphoma (DHL) or double expressing lymphoma (DEL)

• DHL is defined as high grade B-cell lymphoma with one of the below:

• Translocations of MYC and BCL2

• Translocations of MYC and BCL2 and BCL6 (triple hit lymphoma)

• Translocations of MYC and BCL6 without BCL2 translocation BUT with immunohistochemistry (IHC) expression of BCL2 (>=50%)

• DEL is defined as DLBCL or high grade B-cell lymphoma not otherwise specified (NOS) with protein expression by IHC of both MYC (>= 40%) and BCL2 (>= 50%) in the absence of dual translocations of both MYC and BCL2). (Double Expressing Lymphoma, DEL). Local determination of fluorescence in situ hybridization (FISH) and IHC will be performed per standardized guidelines and will be acceptable for study entry, but local IHC and FISH results for MYC must be available in order to determine eligibility if enrolling as DEL based on local results

• The diagnosis of DLBCL/HGBCL and assessment of DEL/DHL will be performed per standardized guidelines at local institutions and patients will be enrolled based on local determination. Given the heterogeneity in diagnostic work-up and interpretation, all local determinations will be followed by central confirmation in real time. Diagnostic slides and stains (or recuts/blocks) from all cases will be submitted to a central reference laboratory (Cleveland Clinic Laboratories). Immunostains will be reviewed or repeated (if unavailable or technically unsatisfactory) to confirm double expressing (DE) status. All DE cases will also be investigated for double hit (DH) status, if not already performed. To exclude DHL status, FISH for translocations of MYC (break apart and IGH/MYC dual fusion probes) must be performed (either by referring site or at the central laboratory), along with BCL2 (break apart probes) and BCL6 (break apart probes). Any missing information from the referring site will be supplemented by the central lab on required submitted unstained slides or blocks. Cases submitted as DHL will be accepted as such upon review of submitted laboratory reports. Cases submitted as DHL must demonstrate the presence of a MYC translocation as well as a translocation of BCL2, BCL6, or both. Cases submitted as a DEL must demonstrate appropriate IHC protein expression of MYC and BCL2, and be negative for a MYC translocation by FISH.

• No prior treatment for DLBCL/HGBCL is allowed with the exception of corticosteroids administered for palliation, or a single cycle of either rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or dose adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) administered prior to enrollment. Corticosteroids or local radiation therapy are also allowed. Patients may have received intrathecal chemotherapy for CNS prophylaxis prior to registration. This single pre-registration cycle is being allowed to facilitate enrolling patients who required immediate initiation of therapy for rapidly progressing disease, or for patients where FISH or IHC results returned after initiation of chemotherapy rendered them protocol eligible. Patients with DLBCL or HGBCL transformed from an underlying indolent lymphoma cannot have received prior chemotherapy, but prior anti-CD20 monoclonal antibody therapy or radiation therapy for an indolent B-cell lymphoma is allowed.

• Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.

• Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required.

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

• Absolute neutrophil count (ANC) >= 1,000/mm^3.

• Unless attributable to lymphoma.

• Platelet count >= 100,000/mm^3.

• Unless attributable to lymphoma.

• Creatinine =< 1.5 mg/dL OR calculated (calc.) creatinine clearance >= 50 mL/min.

• Unless attributable to lymphoma.

• Total bilirubin =< 2.0 mg/dL.

• Unless attributable to lymphoma.

• Unless attributable to Gilbert's disease.

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 times institution upper limit of normal (ULN).

• Unless attributable to lymphoma.

• Archival tissue must be available for submission in all patients for histopathology review, though participation in correlative substudies is optional.

• No active ischemic heart disease or congestive heart failure, and left ventricular ejection fraction (LVEF) >= 45%.

• No known active human immunodeficiency virus (HIV) disease. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

• No known lymphomatous involvement of the central nervous system (CNS). A lumbar puncture or neuroimaging prior to study enrollment is not required in the absence of neurological signs or symptoms concerning for CNS involvement.

• No active hepatitis B or hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and/or surface antigen) are eligible if they have no detectable viral load, and are taking appropriate prophylactic antiviral therapy to prevent reactivation. Patients with history of hepatitis C virus (HCV) are eligible if they have been treated for HCV and have an undetectable HCV viral load.

• Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to initiation of venetoclax.

• Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of venetoclax.

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Anchorage Radiation Therapy Center
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Fairbanks Memorial Hospital
Fairbanks
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
Arkansas
Mercy Hospital Fort Smith
Fort Smith
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Arizona
Cancer Center at Saint Joseph's
Phoenix
California
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Community Cancer Institute
Clovis
University Oncology Associates
Clovis
Loma Linda University Medical Center
Loma Linda
Fremont - Rideout Cancer Center
Marysville
University of California Davis Comprehensive Cancer Center
Sacramento
UCSF Medical Center-Parnassus
San Francisco
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo
Mission Hope Medical Oncology - Santa Maria
Santa Maria
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
The Medical Center of Aurora
Aurora
Boulder Community Foothills Hospital
Boulder
Boulder Community Hospital
Boulder
Rocky Mountain Cancer Centers-Boulder
Boulder
Rocky Mountain Cancer Centers - Centennial
Centennial
Penrose-Saint Francis Healthcare
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Colorado Springs
Cancer Center of Colorado at Sloan's Lake
Denver
Colorado Blood Cancer Institute
Denver
National Jewish Health-Main Campus
Denver
Porter Adventist Hospital
Denver
Presbyterian - Saint Lukes Medical Center - Health One
Denver
Rocky Mountain Cancer Centers-Midtown
Denver
Rocky Mountain Cancer Centers-Rose
Denver
Rose Medical Center
Denver
SCL Health Saint Joseph Hospital
Denver
The Women's Imaging Center
Denver
Western Surgical Care
Denver
Mercy Medical Center
Durango
Southwest Oncology PC
Durango
Mountain Blue Cancer Care Center - Swedish
Englewood
Rocky Mountain Cancer Centers - Swedish
Englewood
Swedish Medical Center
Englewood
The Melanoma and Skin Cancer Institute
Englewood
National Jewish Health-Western Hematology Oncology
Golden
Saint Mary's Hospital and Regional Medical Center
Grand Junction
North Colorado Medical Center
Greeley
Good Samaritan Medical Center
Lafayette
Rocky Mountain Cancer Centers-Lakewood
Lakewood
Saint Anthony Hospital
Lakewood
Littleton Adventist Hospital
Littleton
Rocky Mountain Cancer Centers-Littleton
Littleton
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Sky Ridge Medical Center
Lone Tree
Longmont United Hospital
Longmont
Rocky Mountain Cancer Centers-Longmont
Longmont
McKee Medical Center
Loveland
Parker Adventist Hospital
Parker
Saint Mary Corwin Medical Center
Pueblo
National Jewish Health-Northern Hematology Oncology
Thornton
Rocky Mountain Cancer Centers-Thornton
Thornton
SCL Health Lutheran Medical Center
Wheat Ridge
Delaware
Beebe South Coastal Health Campus
Frankford
Beebe Medical Center
Lewes
Christiana Care Health System-Christiana Hospital
Newark
Delaware Clinical and Laboratory Physicians PA
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Beebe Health Campus
Rehoboth Beach
TidalHealth Nanticoke / Allen Cancer Center
Seaford
Christiana Care Health System-Wilmington Hospital
Wilmington
Florida
Holy Cross Hospital
Fort Lauderdale
Cleveland Clinic-Weston
Weston
Georgia
Emory Saint Joseph's Hospital
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Memorial Health University Medical Center
Savannah
Summit Cancer Care-Memorial
Savannah
Hawaii
Hawaii Cancer Care - Savio
'aiea
Pali Momi Medical Center
'aiea
Queen's Cancer Center - Pearlridge
'aiea
The Cancer Center of Hawaii-Pali Momi
'aiea
Island Urology-Hilo
Hilo
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Hawaii Cancer Care Inc-Liliha
Honolulu
Island Urology
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Kuakini Medical Center
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf
Saint Anthony Regional Hospital
Carroll
Medical Oncology and Hematology Associates-West Des Moines
Clive
Mercy Cancer Center-West Lakes
Clive
Alegent Health Mercy Hospital
Council Bluffs
Greater Regional Medical Center
Creston
Broadlawns Medical Center
Des Moines
Iowa Lutheran Hospital
Des Moines
Iowa Methodist Medical Center
Des Moines
Medical Oncology and Hematology Associates-Des Moines
Des Moines
Mercy Medical Center - Des Moines
Des Moines
Mission Cancer and Blood - Laurel
Des Moines
Trinity Regional Medical Center
Fort Dodge
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Siouxland Regional Cancer Center
Sioux City
MercyOne Waterloo Cancer Center
Waterloo
Mercy Medical Center-West Lakes
West Des Moines
Methodist West Hospital
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Luke's Cancer Institute - Boise
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Kootenai Health - Coeur d'Alene
Coeur D'alene
Walter Knox Memorial Hospital
Emmett
Saint Luke's Cancer Institute - Fruitland
Fruitland
Idaho Urologic Institute-Meridian
Meridian
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Alphonsus Medical Center-Nampa
Nampa
Saint Luke's Cancer Institute - Nampa
Nampa
Kootenai Clinic Cancer Services - Post Falls
Post Falls
Kootenai Cancer Clinic
Sandpoint
Saint Luke's Cancer Institute - Twin Falls
Twin Falls
Illinois
Saint Anthony's Health
Alton
Rush - Copley Medical Center
Aurora
Illinois CancerCare-Bloomington
Bloomington
Illinois CancerCare-Canton
Canton
Memorial Hospital of Carbondale
Carbondale
SIH Cancer Institute
Carterville
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
Northwestern University
Chicago
Rush University Medical Center
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
University of Illinois
Chicago
Carle on Vermilion
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Northwestern Medicine Cancer Center Kishwaukee
Dekalb
Illinois CancerCare-Dixon
Dixon
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Northwestern Medicine Cancer Center Delnor
Geneva
Illinois CancerCare-Kewanee Clinic
Kewanee
Northwestern Medicine Lake Forest Hospital
Lake Forest
Illinois CancerCare-Macomb
Macomb
Carle Physician Group-Mattoon/Charleston
Mattoon
Loyola University Medical Center
Maywood
Good Samaritan Regional Health Center
Mount Vernon
UC Comprehensive Cancer Center at Silver Cross
New Lenox
Cancer Care Center of O'Fallon
O'fallon
University of Chicago Medicine-Orland Park
Orland Park
Illinois CancerCare-Ottawa Clinic
Ottawa
Illinois CancerCare-Pekin
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria
Illinois CancerCare-Peru
Peru
Valley Radiation Oncology
Peru
Illinois CancerCare-Princeton
Princeton
Memorial Medical Center
Springfield
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Southwest Illinois Health Services LLP
Swansea
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Northwestern Medicine Cancer Center Warrenville
Warrenville
Illinois CancerCare - Washington
Washington
Rush-Copley Healthcare Center
Yorkville
Indiana
Reid Health
Richmond
Kansas
Central Care Cancer Center - Garden City
Garden City
Central Care Cancer Center - Great Bend
Great Bend
University of Kansas Cancer Center
Kansas City
University of Kansas Cancer Center-Overland Park
Overland Park
University of Kansas Hospital-Westwood Cancer Center
Westwood
Kentucky
Flaget Memorial Hospital
Bardstown
Commonwealth Cancer Center-Corbin
Corbin
Saint Joseph Hospital East
Lexington
Saint Joseph Radiation Oncology Resource Center
Lexington
Saint Joseph London
London
Jewish Hospital
Louisville
Saints Mary and Elizabeth Hospital
Louisville
UofL Health Medical Center Northeast
Louisville
Jewish Hospital Medical Center South
Shepherdsville
Louisiana
Ochsner LSU Health Monroe Medical Center
Monroe
Louisiana State University Health Science Center
New Orleans
University Medical Center New Orleans
New Orleans
LSU Health Sciences Center at Shreveport
Shreveport
Ochsner LSU Health Saint Mary's Medical Center
Shreveport
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital Cancer Center
Boston
Mercy Medical Center
Springfield
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
University of Maryland/Greenebaum Cancer Center
Baltimore
Walter Reed National Military Medical Center
Bethesda
Maine
Harold Alfond Center for Cancer Care
Augusta
Eastern Maine Medical Center
Bangor
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford
Lafayette Family Cancer Center-EMMC
Brewer
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford
Maine Medical Partners - South Portland
South Portland
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
Bronson Battle Creek
Battle Creek
Saint Joseph Mercy Brighton
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton
Henry Ford Cancer Institute-Downriver
Brownstown
Saint Joseph Mercy Canton
Canton
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton
Caro Cancer Center
Caro
Saint Joseph Mercy Chelsea
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea
Hematology Oncology Consultants-Clarkston
Clarkston
Newland Medical Associates-Clarkston
Clarkston
Henry Ford Macomb Hospital-Clinton Township
Clinton Township
Henry Ford Medical Center-Fairlane
Dearborn
Ascension Saint John Hospital
Detroit
Henry Ford Hospital
Detroit
Great Lakes Cancer Management Specialists-Doctors Park
East China Township
Genesee Cancer and Blood Disease Treatment Center
Flint
Genesee Hematology Oncology PC
Flint
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids
Mercy Health Saint Mary's
Grand Rapids
Spectrum Health at Butterworth Campus
Grand Rapids
Academic Hematology Oncology Specialists
Grosse Pointe Woods
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods
Allegiance Health
Jackson
Borgess Medical Center
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Sparrow Hospital
Lansing
Hope Cancer Clinic
Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb
Michigan Breast Specialists-Macomb Township
Macomb
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette
Mercy Health Mercy Campus
Muskegon
Lakeland Hospital Niles
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores
Henry Ford Medical Center-Columbus
Novi
21st Century Oncology-Pontiac
Pontiac
Hope Cancer Center
Pontiac
Newland Medical Associates-Pontiac
Pontiac
Saint Joseph Mercy Oakland
Pontiac
Spectrum Health Reed City Hospital
Reed City
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills
Ascension Saint Mary's Hospital
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
Saginaw
Lakeland Medical Center Saint Joseph
Saint Joseph
Marie Yeager Cancer Center
Saint Joseph
Henry Ford Macomb Health Center - Shelby Township
Shelby
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights
Ascension Saint Joseph Hospital
Tawas City
Munson Medical Center
Traverse City
Advanced Breast Care Center PLLC
Warren
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren
Macomb Hematology Oncology PC
Warren
Michigan Breast Specialists-Warren
Warren
Saint John Macomb-Oakland Hospital
Warren
Henry Ford West Bloomfield Hospital
West Bloomfield
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch
Metro Health Hospital
Wyoming
Huron Gastroenterology PC
Ypsilanti
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti
Minnesota
Riverwood Healthcare Center
Aitkin
Sanford Joe Lueken Cancer Center
Bemidji
Essentia Health Saint Joseph's Medical Center
Brainerd
Fairview Ridges Hospital
Burnsville
Minnesota Oncology - Burnsville
Burnsville
Cambridge Medical Center
Cambridge
Mercy Hospital
Coon Rapids
Essentia Health - Deer River Clinic
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes
Essentia Health Cancer Center
Duluth
Essentia Health Saint Mary's Medical Center
Duluth
Miller-Dwan Hospital
Duluth
Fairview Southdale Hospital
Edina
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls
Essentia Health - Fosston
Fosston
Unity Hospital
Fridley
Essentia Health Hibbing Clinic
Hibbing
Fairview Clinics and Surgery Center Maple Grove
Maple Grove
Minnesota Oncology Hematology PA-Maplewood
Maplewood
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
Monticello Cancer Center
Monticello
New Ulm Medical Center
New Ulm
Essentia Health - Park Rapids
Park Rapids
Fairview Northland Medical Center
Princeton
North Memorial Medical Health Center
Robbinsdale
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Essentia Health Sandstone
Sandstone
Saint Francis Regional Medical Center
Shakopee
Lakeview Hospital
Stillwater
Sanford Thief River Falls Medical Center
Thief River Falls
Essentia Health Virginia Clinic
Virginia
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Sanford Cancer Center Worthington
Worthington
Fairview Lakes Medical Center
Wyoming
Missouri
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin
Central Care Cancer Center - Bolivar
Bolivar
Parkland Health Center-Bonne Terre
Bonne Terre
Cox Cancer Center Branson
Branson
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
University of Missouri - Ellis Fischel
Columbia
Siteman Cancer Center at West County Hospital
Creve Coeur
Parkland Health Center - Farmington
Farmington
Capital Region Southwest Campus
Jefferson City
Freeman Health System
Joplin
Mercy Hospital Joplin
Joplin
Delbert Day Cancer Institute at PCRMC
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Heartland Regional Medical Center
Saint Joseph
Mercy Hospital Saint Louis
Saint Louis
Mercy Hospital South
Saint Louis
Missouri Baptist Medical Center
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Siteman Cancer Center-South County
Saint Louis
Washington University School of Medicine
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Saint Peters
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Missouri Baptist Sullivan Hospital
Sullivan
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills
Mercy Hospital Washington
Washington
Mississippi
University of Mississippi Medical Center
Jackson
Montana
Community Hospital of Anaconda
Anaconda
Billings Clinic Cancer Center
Billings
Saint Vincent Frontier Cancer Center
Billings
Saint Vincent Healthcare
Billings
Bozeman Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Great Falls Clinic
Great Falls
Kalispell Regional Medical Center
Kalispell
Community Medical Hospital
Missoula
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Wake Forest University at Clemmons
Clemmons
Southeastern Medical Oncology Center-Clinton
Clinton
Duke University Medical Center
Durham
Southeastern Medical Oncology Center-Goldsboro
Goldsboro
Southeastern Medical Oncology Center-Jacksonville
Jacksonville
Vidant Oncology-Kenansville
Kenansville
Vidant Oncology-Kinston
Kinston
Vidant Oncology-Richlands
Richlands
Wake Forest University Health Sciences
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Essentia Health Cancer Center-South University Clinic
Fargo
Sanford Broadway Medical Center
Fargo
Sanford Medical Center Fargo
Fargo
Sanford Roger Maris Cancer Center
Fargo
Sanford South University Medical Center
Fargo
Southpointe-Sanford Medical Center Fargo
Fargo
Essentia Health - Jamestown Clinic
Jamestown
Nebraska
Nebraska Medicine-Bellevue
Bellevue
CHI Health Saint Francis
Grand Island
CHI Health Good Samaritan
Kearney
Saint Elizabeth Regional Medical Center
Lincoln
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Immanuel Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Creighton University Medical Center
Omaha
Nebraska Medicine-Village Pointe
Omaha
Nebraska Methodist Hospital
Omaha
University of Nebraska Medical Center
Omaha
Midlands Community Hospital
Papillion
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
New Jersey
Saint Barnabas Medical Center
Livingston
Morristown Medical Center
Morristown
Rutgers Cancer Institute of New Jersey
New Brunswick
The Valley Hospital-Luckow Pavilion
Paramus
Neurosurgeons of New Jersey-Ridgewood
Ridgewood
Valley Hospital
Ridgewood
Overlook Hospital
Summit
Valley Health System-Hematology/Oncology
Westwood
New Mexico
Presbyterian Kaseman Hospital
Albuquerque
University of New Mexico Cancer Center
Albuquerque
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho
New York
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn
Roswell Park Cancer Institute
Buffalo
Glens Falls Hospital
Glens Falls
Northwell Health/Center for Advanced Medicine
Lake Success
North Shore University Hospital
Manhasset
Long Island Jewish Medical Center
New Hyde Park
NYP/Weill Cornell Medical Center
New York
Upstate Cancer Center at Oneida
Oneida
University of Rochester
Rochester
State University of New York Upstate Medical University
Syracuse
Ohio
Indu and Raj Soin Medical Center
Beavercreek
Strecker Cancer Center-Belpre
Belpre
Saint Elizabeth Boardman Hospital
Boardman
Cleveland Clinic Mercy Hospital
Canton
Mercy Hematology and Oncology Associates Inc
Canton
Dayton Physicians LLC-Miami Valley South
Centerville
Miami Valley Hospital South
Centerville
Adena Regional Medical Center
Chillicothe
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
Cincinnati
Oncology Hematology Care Inc-Kenwood
Cincinnati
TriHealth Cancer Institute-Anderson
Cincinnati
TriHealth Cancer Institute-Westside
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
MetroHealth Medical Center
Cleveland
Columbus Oncology and Hematology Associates Inc
Columbus
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Mount Carmel East Hospital
Columbus
Mount Carmel Health Center West
Columbus
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Dayton Physician LLC-Miami Valley Hospital North
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Delaware Health Center-Grady Cancer Center
Delaware
Grady Memorial Hospital
Delaware
Dublin Methodist Hospital
Dublin
Armes Family Cancer Center
Findlay
Blanchard Valley Hospital
Findlay
Orion Cancer Care
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Dayton Physicians LLC-Atrium
Franklin
Central Ohio Breast and Endocrine Surgery
Gahanna
Dayton Physicians LLC-Wayne
Greenville
Wayne Hospital
Greenville
Mount Carmel Grove City Hospital
Grove City
First Dayton Cancer Care
Kettering
Greater Dayton Cancer Center
Kettering
Kettering Medical Center
Kettering
Fairfield Medical Center
Lancaster
Saint Rita's Medical Center
Lima
Cleveland Clinic Cancer Center Mansfield
Mansfield
OhioHealth Mansfield Hospital
Mansfield
Marietta Memorial Hospital
Marietta
OhioHealth Marion General Hospital
Marion
Hillcrest Hospital Cancer Center
Mayfield Heights
Knox Community Hospital
Mount Vernon
Licking Memorial Hospital
Newark
Newark Radiation Oncology
Newark
Mercy Health Perrysburg Cancer Center
Perrysburg
Southern Ohio Medical Center
Portsmouth
North Coast Cancer Care
Sandusky
Springfield Regional Cancer Center
Springfield
Springfield Regional Medical Center
Springfield
Cleveland Clinic Cancer Center Strongsville
Strongsville
Mercy Health - Saint Anne Hospital
Toledo
Saint Vincent Mercy Medical Center
Toledo
Dayton Physicians LLC-Upper Valley
Troy
Upper Valley Medical Center
Troy
Saint Joseph Warren Hospital
Warren
South Pointe Hospital
Warrensville Heights
University of Cincinnati Cancer Center-West Chester
West Chester
Saint Ann's Hospital
Westerville
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster
Saint Elizabeth Youngstown Hospital
Youngstown
Genesis Healthcare System Cancer Care Center
Zanesville
Oklahoma
Cancer Centers of Southwest Oklahoma Research
Lawton
Mercy Hospital Oklahoma City
Oklahoma City
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Saint Alphonsus Medical Center-Baker City
Baker City
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Providence Cancer Institute Clackamas Clinic
Clackamas
Bay Area Hospital
Coos Bay
Providence Newberg Medical Center
Newberg
Saint Alphonsus Medical Center-Ontario
Ontario
Oregon Health and Science University
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Saint Charles Health System-Redmond
Redmond
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Christiana Care Health System-Concord Health Center
Chadds Ford
Chambersburg Hospital
Chambersburg
Geisinger Medical Center
Danville
Pocono Medical Center
East Stroudsburg
Ephrata Cancer Center
Ephrata
Ephrata Community Hospital
Ephrata
Adams Cancer Center
Gettysburg
Cherry Tree Cancer Center
Hanover
Geisinger Medical Center-Cancer Center Hazleton
Hazleton
Lehigh Valley Hospital-Hazleton
Hazleton
Sechler Family Cancer Center
Lebanon
Geisinger Medical Oncology-Lewisburg
Lewisburg
Lewistown Hospital
Lewistown
University of Pennsylvania/Abramson Cancer Center
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
Geisinger Cancer Services-Pottsville
Pottsville
Community Medical Center
Scranton
Geisinger Medical Oncology-Selinsgrove
Selinsgrove
Geisinger Medical Group
State College
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
WellSpan Health-York Cancer Center
York
WellSpan Health-York Hospital
York
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Medical University of South Carolina
Charleston
Prisma Health Cancer Institute - Laurens
Clinton
Prisma Health Cancer Institute - Easley
Easley
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Saint Francis Cancer Center
Greenville
Saint Francis Hospital
Greenville
Self Regional Healthcare
Greenwood
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Texas
Saint Joseph Regional Cancer Center
Bryan
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Utah
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork
Sandra L Maxwell Cancer Center
Cedar City
Logan Regional Hospital
Logan
Intermountain Medical Center
Murray
McKay-Dee Hospital Center
Ogden
Utah Valley Regional Medical Center
Provo
Riverton Hospital
Riverton
Saint George Regional Medical Center
Saint George
Huntsman Cancer Institute/University of Utah
Salt Lake City
LDS Hospital
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Salt Lake City
Virginia
Cancer Specialists of Tidewater Limited
Chesapeake
Inova Schar Cancer Institute
Fairfax
Inova Fairfax Hospital
Falls Church
Peninsula Cancer Institute-Gloucester
Gloucester
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg
Peninsula Cancer Institute-Newport News
Newport News
Riverside Shore Cancer Center
Onancock
Virginia Cancer Institute
Richmond
Virginia Commonwealth University/Massey Cancer Center
Richmond
Cancer Specialists of Tidewater-Suffolk
Suffolk
Peninsula Cancer Institute-Cancer Specialists of Tidewater
Virginia Beach
Peninsula Cancer Institute-Williamsburg
Williamsburg
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin
University of Vermont and State Agricultural College
Burlington
University of Vermont Medical Center
Burlington
Norris Cotton Cancer Center-North
Saint Johnsbury
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
MultiCare Auburn Medical Center
Auburn
PeaceHealth Saint Joseph Medical Center
Bellingham
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton
Harrison Medical Center
Bremerton
Highline Medical Center-Main Campus
Burien
Providence Regional Cancer System-Centralia
Centralia
Swedish Cancer Institute-Edmonds
Edmonds
Saint Elizabeth Hospital
Enumclaw
Providence Regional Cancer Partnership
Everett
Saint Francis Hospital
Federal Way
MultiCare Gig Harbor Medical Park
Gig Harbor
Swedish Cancer Institute-Issaquah
Issaquah
Kadlec Clinic Hematology and Oncology
Kennewick
Providence Regional Cancer System-Lacey
Lacey
Saint Clare Hospital
Lakewood
PeaceHealth Saint John Medical Center
Longview
Jefferson Healthcare
Port Townsend
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo
MultiCare Good Samaritan Hospital
Puyallup
Pacific Gynecology Specialists
Seattle
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-Cherry Hill
Seattle
Swedish Medical Center-First Hill
Seattle
PeaceHealth United General Medical Center
Sedro-woolley
Providence Regional Cancer System-Shelton
Shelton
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley
Franciscan Research Center-Northwest Medical Plaza
Tacoma
Mary Bridge Children's Hospital and Health Center
Tacoma
MultiCare Tacoma General Hospital
Tacoma
Northwest Medical Specialties PLLC
Tacoma
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
Providence Regional Cancer System-Yelm
Yelm
Wisconsin
ThedaCare Regional Cancer Center
Appleton
Duluth Clinic Ashland
Ashland
Northwest Wisconsin Cancer Center
Ashland
Aurora Cancer Care-Southern Lakes VLCC
Burlington
Marshfield Medical Center-EC Cancer Center
Eau Claire
Aurora Health Care Germantown Health Center
Germantown
Aurora Cancer Care-Grafton
Grafton
Aurora BayCare Medical Center
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
Aurora Cancer Care-Kenosha South
Kenosha
Gundersen Lutheran Medical Center
La Crosse
Aurora Bay Area Medical Group-Marinette
Marinette
Marshfield Medical Center-Marshfield
Marshfield
Aurora Cancer Care-Milwaukee
Milwaukee
Aurora Saint Luke's Medical Center
Milwaukee
Aurora Sinai Medical Center
Milwaukee
Medical College of Wisconsin
Milwaukee
Marshfield Clinic-Minocqua Center
Minocqua
ProHealth D N Greenwald Center
Mukwonago
Cancer Center of Western Wisconsin
New Richmond
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls
ThedaCare Cancer Care - Oshkosh
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh
Aurora Cancer Care-Racine
Racine
Marshfield Medical Center-Rice Lake
Rice Lake
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
Aurora Medical Center in Summit
Summit
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers
ProHealth Waukesha Memorial Hospital
Waukesha
UW Cancer Center at ProHealth Care
Waukesha
Aurora Cancer Care-Milwaukee West
Wauwatosa
Aurora West Allis Medical Center
West Allis
Marshfield Medical Center - Weston
Weston
Wyoming
Cheyenne Regional Medical Center-West
Cheyenne
Billings Clinic-Cody
Cody
Welch Cancer Center
Sheridan
Time Frame
Start Date: August 7, 2019
Completion Date: April 1, 2028
Participants
Target number of participants: 374
Treatments
Active Comparator: Arm 1 (R-CHOP, DA-EPOCH-R)
DEL: Patients with DEL receive R-CHOP chemotherapy regimen consisting of rituximab IV on day 1, cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.~DHL: Patients with DHL receive DA-EPOCH-R chemotherapy regimen consisting of rituximab IV on day 1, doxorubicin hydrochloride IV on days 1-4, etoposide IV on days 1-4, vincristine sulfate IV on days 1-4, prednisone PO BID on days 1-5, and cyclophosphamide IV on day 5. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Experimental: Arm 2 (R-CHOP, DA-EPOCH-R, venetoclax)
DEL: Patients with DEL receive R-CHOP chemotherapy regimen as in Arm 1. Patients also receive venetoclax PO QD on days 4-8 of cycle 1 and days 1-5 for cycles 2-6. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.~DHL: Patients with DHL receive DA-EPOCH-R chemotherapy regimen as in Arm 1. Patients also receive venetoclax PO QD on days 4-8 of cycle 1 and days 1-5 for cycles 2-6. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
Authors
Sami Ibrahimi, Tahir Latif, Robert J. Behrens, Danielle A. Shafer, Stefano R. Tarantolo, Bryan A. Faller, Matthew A. Lunning, Preston D. Steen, Brian T. Hess, Chanh T. Huynh, Karen G. Zeman, Howard M. Gross, Jay W. Carlson, Boyu Hu, Timothy S. Fenske, Daniel J. Landsburg, Umar Farooq, Marc S. Hoffmann, Timothy R. Wassenaar, Samer S. Kasbari, Sarah C. Rutherford, Sarah J. Sinclair, Robert M. Eisner, Victor Y. Yazbeck, Farrukh T. Awan, Timothy D. Moore, Paul M. Barr, John M. Schallenkamp, Ding Wang, Jeremy S Abramson, Yazhini Vallatharasu, Joseph M. Tuscano, Gregory A. Masters, Matthew Fero, Keren Sturtz, Joel M. Brothers, Julian R. Sprague, David B. Duggan, Mohamad A. Cherry, Jeffrey Crawford, Alison K. Conlin, Nasheed M. Hossain, Robert D. Siegel, Misbah U. Qadir, Nicholas DiBella, Sadia Riaz, Donald B. Wender, Anusha Vallurupalli, Ki Y. Chung, Frederick Lansigan, Sonali M. Smith, Jason Suh, Deepa Jagadeesh, Craig S. Boddy, Donald C. Doll, Mayur Narkhede, Kirsten M. Boughan, Daniel M. Anderson, Parth R. Rao, Kristie A. Blum, Kevin A. David, Anthony J. Jaslowski, Bret E. Friday, Michael Husak, Suchitra Sundaram, Michael O. Ojelabi, Rachit Kumar, Mukund Nadipuram, Sherjeel Sana, Talal Hilal, Richard L. Deming, Haifaa Abdulhaq, Suparna Mantha, Reem Karmali, Christopher B. Jones, Mitchell Haut, Christopher E. Dittus, Irum Khan, Eshan Patel, Nina D. Wagner-Johnston, Nancy L. Bartlett, Kathleen J. Yost, Seo-Hyun Kim, John P. Galvin, Suki Subbiah, Charalambos Andreadis, Christopher M. Reynolds, William E. Burak, Seung Tae Lee, Francisco J. Hernandez-ILizaliturri, Craig Y. Okada, Rakhee Vaidya
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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