A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma
OBJECTIVES:
Primary
- To compare the complete remission rate in patients with high-risk follicular lymphoma
receiving induction therapy comprising bendamustine hydrochloride and rituximab with vs
without bortezomib.
- To compare the 1-year post-induction disease-free survival rate in patients receiving
continuation therapy comprising rituximab with vs without lenalidomide.
Secondary
- To determine the 3-year progression-free survival and the 5-year overall survival of
these patients.
- To evaluate patient-reported outcomes at baseline and during treatment to determine
differences in symptom palliation, treatment-related symptoms, and overall
health-related quality of life.
- To examine the association between baseline FLIPI information and outcome of these
patients.
- To examine the association between baseline and end-of-treatment patient comorbidities
assessed by the Cumulative Illness Rating Scale (CIRS) and outcome.
- To create an image and tissue bank including serial PET/CT scans, diagnostic
paraffin-embedded tissue, germline DNA, and serial blood and bone marrow samples
sufficient to support proposed and future studies of tumor and host characteristics
that may predict for clinical outcome, including treatment arm effects, and enhance
existing prognostic indices. (exploratory)
OUTLINE: Patients are stratified according to FLIPI-1score (1 or 2 vs 3 vs 4 or 5) and GELF
tumor burden (low vs high). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1
hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of
disease progression or unacceptable toxicity.
Beginning 4 weeks after the completion of induction therapy, patients receive rituximab IV
on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression
or unacceptable toxicity.
- Arm II: Patients receive rituximab IV on day 1; bortezomib IV on days 1, 4, 8, and 11;
and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every
28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Beginning 4 weeks after the completion of induction therapy, patients receive rituximab as
in arm I.
- Arm III: Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over
1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of
disease progression or unacceptable toxicity.
Immediately after completing induction therapy, patients receive oral lenalidomide on days
1-21. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression
or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy,
patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the
absence of disease progression or unacceptable toxicity.
Quality of life (including fatigue, neurotoxicity, anxiety, and depression) is assessed by
questionnaire at baseline and periodically during study therapy.
Blood, bone marrow, and tissue samples may be collected periodically for correlative studies
and for a repository.
After completion of study therapy, patients are followed up periodically for 15 years.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Complete remission (CR) rate after induction therapy
No
Andrew M. Evens, DO, MS
Principal Investigator
Robert H. Lurie Cancer Center
Unspecified
CDR0000683312
NCT01216683
December 2010
Name | Location |
---|---|
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
St. Joseph Hospital | Denver, Colorado 80218 |
Rose Medical Center | Denver, Colorado 80220 |
Swedish Medical Center | Englewood, Colorado 80110 |
Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
St. Mary - Corwin Regional Medical Center | Pueblo, Colorado 81004 |
North Suburban Medical Center | Thornton, Colorado 80229 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
MeritCare Bemidji | Bemidji, Minnesota 56601 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Duluth Clinic Cancer Center - Duluth | Duluth, Minnesota 55805-1983 |
CCOP - Duluth | Duluth, Minnesota 55805 |
Miller - Dwan Medical Center | Duluth, Minnesota 55805 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Dean Medical Center - Madison | Madison, Wisconsin 53717 |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Wesley Medical Center | Wichita, Kansas 67214 |
Bellin Memorial Hospital | Green Bay, Wisconsin 54301 |
UMDNJ University Hospital | Newark, New Jersey 07103 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Dakota Cancer Institute at Dakota Clinic - South University | Fargo, North Dakota 58103-4940 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
Fox Valley Hematology and Oncology - East Grant Street | Appleton, Wisconsin 54911-3496 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
St. Joseph's Medical Center | Brainerd, Minnesota 56401 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Toledo Clinic - Oregon | Oregon, Ohio 43616 |
Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
St. Anthony Central Hospital | Denver, Colorado 80204-1335 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois 60714 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Geisinger Hazleton Cancer Center | Hazleton, Pennsylvania 18201 |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton, Pennsylvania 18510 |
Marshfield Clinic - Chippewa Center | Chippewa Falls, Wisconsin 54729 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center | Green Bay, Wisconsin 54311 |
UW Cancer Center Johnson Creek | Johnson Creek, Wisconsin 53038 |
Vince Lombardi Cancer Clinic - Marinette | Marinette, Wisconsin 54143 |
Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
Vince Lombardi Cancer Clinic - Sheboygan | Sheboygan, Wisconsin 53081 |
Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Aurora Medical Center | Summit, Wisconsin 53066 |
Vince Lombardi Cancer Clinic - Two Rivers | Two Rivers, Wisconsin 54241 |
Oncology Alliance, SC - Milwaukee - West | Wauwatosa, Wisconsin 53226 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin 53066 |
University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau, Wisconsin 54401 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Cancer Center of Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
Clarian Arnett Cancer Care | Lafayette, Indiana 47904 |
California Cancer Care, Incorporated - Greenbrae | Greenbrae, California 94904 |
Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh, Wisconsin 54904 |
Langlade Memorial Hospital | Antigo, Wisconsin 54409 |
Riverview UW Cancer Center at Riverview Hospital | Wisconsin Rapids, Wisconsin 54494 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
Roger Maris Cancer Center at MeritCare Hospital | Fargo, North Dakota 58122 |
Horizon Oncology Center | Lafayette, Indiana 47905 |