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A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)


OBJECTIVES:

Primary

- To assess the 5-year progression-free survival (PFS) rate in patients with newly
diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission
tomography (PET)/CT scan to direct therapy after 3 courses of rituximab,
cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone
(R-CHOP).

Secondary

- To evaluate PFS within the PET-positive (+) and PET-negative (-) subgroups of patients
with newly diagnosed limited-stage DLBCL.

- To evaluate toxicity of the protocol treatments in this patient population.

- To evaluate the response probability in this patient population.

- To evaluate overall survival in the overall population, and within the PET+ and PET-
subgroups.

- To estimate the rate of upstaging at baseline by PET/CT at baseline among patients
newly diagnosed with limited-stage DLBCL by CT imaging and to describe outcomes in
patients upstaged by PET/CT at baseline to advanced DLBCL.

- To describe outcomes in the subgroup of patients upstaged by PET/CT.

- To evaluate the association of germinal center B-cell subtype (GCB) vs stromal-1 vs
stromal-2 gene expression signatures with PFS or overall survival.

OUTLINE: This is a multicenter study. Patients are stratified according to whether the
patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT
(yes vs no).

Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over
30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and
prednisone orally on days 1-5. Treatment repeats every 21 days for 3* courses. NOTE:
*Patients found to have advanced stage DLBCL based on local review of the baseline PET scan
receive 6 courses of R-CHOP.

FDG/PET - Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography
(FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion
of course 3. Patients with complete response (PET scan negative) receive one additional
course of R-CHOP as above. Patients with partial response (PET scan positive) undergo
involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.

Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium
Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or
9.

Patients may undergo blood sample collection at baseline for correlative studies. Bone
marrow tissue samples may be also collected for correlative studies.

After completion of study therapy, patients are followed up every 6 months for 2 years and
then yearly for 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Patients must have biopsy-proven diffuse large B-cell lymphoma (DLBCL)

- Adequate sections or a paraffin block from the original diagnostic specimen must
be submitted for review by the lymphoma pathology group

- Lymphoma must express CD20 antigen by either flow cytometry using anti-CD20
antibodies or by immunoperoxidase staining of paraffin sections

- Patients with primary mediastinal lymphoma or testicular lymphoma are not
eligible

- Patients must have non-bulky stage I or II disease by Ann Arbor classification

- This staging excludes FDG-PET evaluation

- Patients who have stage I or II non-bulky disease on diagnostic CT scan, but are
upstaged to stage III or IV based on FDG-PET evaluation, are also eligible

- Patients must have a diagnostic quality contrast-enhanced CT scan of the chest,
abdomen, and pelvis AND baseline FDG-PET scan performed within 28 days prior to
registration

- Low-resolution "localization" CT scans performed as part of a combined PET/CT
scan are not adequate for enrollment or response determination on this protocol

- If a patient has an allergy to CT contrast, then a non-enhanced CT will be
acceptable

- Patients must not have clinical evidence of central nervous system (CNS) involvement
by lymphoma

- Any laboratory or radiographic tests performed to assess CNS involvement must be
negative and must be performed within 42 days prior to registration

- Patients may have either measurable or evaluable limited-stage DLBCL

- Patients rendered free of measurable or evaluable disease by virtue of biopsy
(resection) are also eligible

- If patient has measurable disease it must be documented on the Lymphoma Baseline
Tumor Assessment Form (Form #15187)

- All measurable disease must be assessed within 28 days prior to registration

- Patients with non-measurable disease in addition to measurable disease must have
all non-measurable disease assessed within 42 days prior to registration

- Patients must have a unilateral or bilateral bone marrow biopsy performed within 42
days prior to registration

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- ANC ≥ 1,000/mm³

- Platelet count ≥ 100,000/mm³

- Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert
syndrome)

- Patients must not be pregnant or nursing

- Women/men of reproductive potential must have agreed to use an effective
contraceptive method during the study period

- Patients must not be known to be HIV-positive

- No other prior malignancy is allowed except for the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer from which the patient is currently in
complete remission

- Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

- Patients must not have received prior chemotherapy, radiotherapy, or antibody therapy
for lymphoma

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Five-year PFS rate of patients with DLBCL

Safety Issue:

No

Principal Investigator

Daniel O. Persky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

Unspecified

Study ID:

CDR0000700624

NCT ID:

NCT01359592

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
Hurley Medical Center Flint, Michigan  48503
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
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
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
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
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
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
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
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Dayton Kettering, Ohio  45429
CCOP - Greenville Greenville, South Carolina  29615
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Yale Cancer Center New Haven, Connecticut  06520-8028
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown, West Virginia  26506
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise, Idaho  83712-6297
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Gundersen Lutheran Center for Cancer and Blood La Crosse, Wisconsin  54601
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Hematology Oncology Associates - Skokie Skokie, Illinois  60076
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
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
Hematology and Oncology Associates Chicago, Illinois  60611
Eureka Community Hospital Eureka, Illinois  61530
North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
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
Oncology Hematology Associates of Central Illinois, PC - 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
Perry Memorial Hospital Princeton, Illinois  61356
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Iredell Memorial Hospital Statesville, North Carolina  28677
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Cancer Therapy and Research Center San Antonio, Texas  78229
University Hospital - San Antonio San Antonio, Texas  78229
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
St. Anthony Central Hospital Denver, Colorado  80204-1335
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Kaiser Permanente - Denver Denver, Colorado  80205
Kaiser Permanente - Lafayette Lafayette, Colorado  80026
John B. Amos Cancer Center Columbus, Georgia  31904
Harbin Clinic Cancer Center - Medical Oncology Rome, Georgia  30165
Kellogg Cancer Care Center Highland Park, Illinois  60035
Cancer Care and Hematology Specialists of Chicagoland - Niles Niles, Illinois  60714
Reid Hospital & Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Menorah Medical Center Overland Park, Kansas  66209
Saint Luke's Hospital - South Overland Park, Kansas  66213
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Heartland Hematology Oncology Associates, Incorporated Kansas City, Missouri  64118
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Saint Joseph Oncology, Incorporated Saint Joseph, Missouri  64507
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Wayne Hospital Greenville, Ohio  45331
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Rex Cancer Center at Rex Hospital Raleigh, North Carolina  27607
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Greenville Hospital Cancer Center Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Grove Commons Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris Road Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas - Seneca Seneca, South Carolina  29672
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Providence Cancer Center Anchorage, Alaska  99508
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Parvin Radiation Oncology Kansas City, Missouri  64116
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
Hawaii Medical Center - East Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
Illinois CancerCare - Bloomington Bloomington%, Illinois  61701
Illinois CancerCare - Canton Canton, Illinois  61520
Illinois CancerCare - Carthage Carthage, Illinois  62321
Illinois CancerCare - Eureka Eureka, Illinois  61530
Illinois CancerCare - Galesburg Galesburg, Illinois  61401
Illinois CancerCare - Havana Havana, Illinois  62644
Illinois CancerCare - Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare - Macomb Macomb, Illinois  61455
OSF Holy Family Medical Center Monmouth, Illinois  61462
Illinois CancerCare - Monmouth Monmouth, Illinois  61462
Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
Illinois CancerCare - Pekin Pekin, Illinois  61603
Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Illinois CancerCare - Spring Valley Spring Valley, Illinois  61362
Provena St. Mary's Regional Cancer Center - Kankakee Kankakee, Illinois  60901
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
CCOP - Kansas City Prairie Village, Kansas  66208
Piedmont Fayette Hospital Fayetteville, Georgia  30214
Castle Medical Center Kailua, Hawaii  96734
Kauai Medical Clinic Lihue, Hawaii  96766
Island Hospital Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center Cancer Center Burien, Washington  98166
Littleton Adventist Hospital Littleton, Colorado  80122
Parker Adventist Hospital Parker, Colorado  80138
New Ulm Medical Center New Ulm, Minnesota  56073
Roger Maris Cancer Center at MeritCare Hospital Fargo, North Dakota  58122
Kuakini Medical Center Honolulu, Hawaii  96817
Cancer Center of Kansas, PA - McPherson McPherson, Kansas  67460
Oncare Hawaii, Incorporated - Pali Momi Aiea, Hawaii  96701
Leeward Radiation Oncology Ewa Beach, Hawaii  96706