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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
Open (Enrolling)

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Trial Information

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



- 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


- 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-

- 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

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


- 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

- 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

- 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

- 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


- 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

- 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


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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Five-year PFS rate of patients with DLBCL

Safety Issue:


Principal Investigator

Daniel O. Persky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University



Study ID:




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



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Bronson Methodist Hospital Kalamazoo, Michigan  49007
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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
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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
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Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
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Methodist Medical Center of Illinois Peoria, Illinois  61636
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Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
Yale Cancer Center New Haven, Connecticut  06520-8028
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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
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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
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Olympic Hematology and Oncology Bremerton, Washington  98310
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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
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Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
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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
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Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
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North Shore Oncology and Hematology Associates, Limited - Libertyville Libertyville, Illinois  60048
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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
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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
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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
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Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
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Heartland Regional Medical Center Saint Joseph, Missouri  64506
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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
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Wayne Hospital Greenville, Ohio  45331
St. Joseph Cancer Center Bellingham, Washington  98225
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Provena St. Mary's Regional Cancer Center - Kankakee Kankakee, Illinois  60901
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Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
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Castle Medical Center Kailua, Hawaii  96734
Kauai Medical Clinic Lihue, Hawaii  96766
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Highline Medical Center Cancer Center Burien, Washington  98166
Littleton Adventist Hospital Littleton, Colorado  80122
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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
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