Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/12/2018
Start Date:May 2005

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Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas

This randomized phase III trial studies rituximab when given together with two different
combination chemotherapy regimens to compare how well they work in treating patients with
diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may
block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy
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 rituximab together
with combination chemotherapy may kill more cancer cells. It is not yet known which
combination chemotherapy regimen is more effective when given with rituximab in treating
diffuse large B-cell non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying rituximab when given together with two
different combination chemotherapy regimens to compare how well they work in treating
patients with diffuse large B-cell lymphoma.

PRIMARY OBJECTIVES:

I. To compare the event-free survival of rituximab, cyclophosphamide, doxorubicin
hydrochloride, vincristine sulfate, prednisone (R-CHOP) versus dose-adjusted (DA-) etoposide,
prednisone, vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, and rituximab
(EPOCH-R) chemotherapy in untreated cluster of differentiation (CD)20 positive (+) diffuse
large B-cell lymphomas.

II. To develop a molecular predictor of outcome of R-CHOP and DA-EPOCH-R chemotherapy using
molecular profiling.

SECONDARY OBJECTIVES:

I. To compare the response rates, overall survival and toxicity of R-CHOP versus DA-EPOCH-R.

II. To define the pharmacogenomics of untreated diffuse large B-cell lymphoma (DLBCL) and
correlate clinical parameters (toxicity, response, survival outcomes and laboratory results)
with molecular profiling.

III. To assess the use of molecular profiling for pathological diagnosis. IV. To identify new
therapeutic targets using molecular profiling. V. To perform a comprehensive analysis of
somatic alterations to the tumor genome and to understand which genomic alterations are
somatically acquired by the tumor and which are encoded in the germ line of the patient.

VI. To identify biomarkers of response to chemotherapy by fludeoxyglucose F 18 (FDG)-positron
emission tomography (PET)/computed tomography (CT) imaging that are predictive of
histopathologic remissions and survival in patients with stage I (mediastinal), II, III, or
IV untreated DLBCL.

VII. To evaluate the use of semiquantitative measurements of FDG uptake in defining
FDG-PET/CT based biomarkers of response to chemotherapy in patients with DLBCL.

VIII. To determine whether FDG-PET/CT measurements of tumor response after the second cycle
of chemotherapy can predict clinical response.

IX. To establish a standardized protocol for FDG-PET/CT image acquisition. X. To determine
additional FDG-PET/CT parameters (e.g., the ratio of tumor maximum standard uptake value
[SUVmax] to liver SUVmean; SUVs corrected for body surface area and lean body mass; nuclear
medicine physician's assessment) and evaluate their utility in refining FDG-PET/CT based
biomarkers of response to therapy.

XI. To evaluate inter-institutional reproducibility of FDG-PET/CT measurements for this
indication.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

1. Histologically documented de novo CD20+ DLBCL with stage II, III or IV disease.

- Stage I primary mediastinal (thymic) DLBCL is also eligible.

- Patients with an underlying low-grade lymphoma, such as a transformed lymphoma or
low-grade lymphoma in the bone marrow, are not eligible.

- Diagnosis should be based on an adequate tissue sample, including open biopsy or
core needle biopsy.

- Needle aspiration for primary diagnosis is unacceptable.

- Patients must have one of the following WHO classification subtypes:

- Diffuse large B-cell lymphoma (includes morphological variants:
centroblastic, immunoblastic, T-cell/histiocyte rich, and anaplastic)

- Mediastinal (thymic) large B-cell lymphoma

- Intravascular large B-cell lymphoma

- Note: Failure to submit a pathology block within 60 days of patient registration
will be considered a major protocol violation.

- Fresh (frozen) tumor biopsy must be available or attempted. A frozen tumor
biopsy equivalent to a minimum of four at least 16 gauge needle cores is an
important component of this study.

- Patients without adequate frozen material should have a biopsy performed to
obtain material.

- If a biopsy is performed and does not yield adequate material, the patient
is still eligible for the study. If a biopsy cannot be done safely, the
patient may still be eligible for the study if permission is granted.

- Note: This study does not allow concurrent radiation unless a patient has a
documented CNS treatment failure with no systemic failure.

2. No prior cytotoxic chemotherapy or rituximab. Patients may be entered if they have
received prior limited field radiation therapy or a short course of glucocorticoids (<
10 days) for an urgent local disease complication at diagnosis (e.g., cord
compression, SVC syndrome). Patients who have received chemotherapy for prior
malignancies are not eligible.

3. Age ≥ 18 years

4. ECOG Performance Status 0-2

5. No active ischemic heart disease or congestive heart failure. If there is suspicion of
cardiac disease, a cardiac ejection fraction must show LVEF > 45%, but the study is
not required

6. No known lymphomatous involvement of the CNS. A lumbar puncture prior to study is not
required in the absence of neurological symptoms

7. No known HIV disease. Patients with a history of intravenous drug abuse or any other
behavior associated with an increased risk of HIV infection should be tested for
exposure to the HIV virus. Patients who test positive or who are known to be infected
are not eligible.

8. Non pregnant and non-nursing. Treatment would expose an unborn child to significant
risks. Women and men of reproductive potential should agree to use an effective form
of contraception.

9. Patients with active medical processes (e.g., uncontrolled bacterial or viral
infection, bleeding) not related to their lymphoma should be excluded.

10. Required Initial Laboratory Values (unless non-Hodgkin lymphoma):

- ANC ≥ 1000/μL

- Platelets ≥ 100,000/μL

- Creatinine≤ 1.5 mg/dL or creatinine clearance ≥ 50 cc/min

- Total Bilirubin ≤ 2 mg/dL (unless a history of Gilbert's Disease)
We found this trial at
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1740 E Broad St
Hazleton, Pennsylvania 18201
(570) 459-2901
Geisinger Hazleton Cancer Center At the Geisinger Cancer Institute, we strive to better understand cancer...
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2401 West Belvedere Avenue
Baltimore, Maryland 21215
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200 Hawthorne Lane
Charlotte, North Carolina 28233
704-384-4000
Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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100 North Academy Ave
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
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500 University Drive
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Penn State Milton S....
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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1300 York Avenue # A421
New York, New York 10065
New York Weill Cornell Cancer Center at Cornell University Welcome to the Division of Hematology...
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4800 Friendship Avenue
Pittsburgh, Pennsylvania 15224
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401 College Street
Richmond, Virginia 23298
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Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-5830
James P. Wilmot Cancer Center at University of Rochester Medical Center The Wilmot Cancer Center...
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34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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130 Fisher Road
Berlin, Vermont 05602
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Mountainview Medical Our medical oncologists, hematologist, and oncology advanced practice nurse, along with other dedicated...
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Bethesda, Maryland 20889
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
312.355.1625
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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250 Pleasant Street
Concord, New Hampshire 03301
603-224-2556
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100 Park Street
Glens Falls, New York 12801
518.926.1000
Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls Hospital is the largest...
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960 S. Columbia Rd.
Grand Forks, North Dakota 58201
701-780-5400
Altru Cancer Center at Altru Hospital From chemotherapy and radiation therapy to personal holistic services,...
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200 Technology Drive
Hooksett, New Hampshire 03106
603-622-6484
New Hampshire Oncology - Hematology, PA - Hooksett New Hampshire Oncology-Hematology, PA (NHOH) was founded...
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La Jolla, California 92093
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1000 N Oak Ave
Marshfield, Wisconsin 54449
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Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
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611 Saint Joseph Avenue
Marshfield, Wisconsin 54449
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Saint Joseph's Hospital Our Mission as a Catholic health care system is to further the...
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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Minocqua, Wisconsin 54548
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Mountain View, California 94040
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
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330 Washington St #220
Norwich, Connecticut 06360
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Eastern Connecticut Hematology and Oncology Associates In 1985 Dr. Dennis Slater moved from Memorial Sloan-Kettering...
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Palo Alto, California 94301
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2251 North Shore Drive
Rhinelander, Wisconsin 54501
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Ministry Medical Group at Saint Mary's Hospital Ministry Saint Mary
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Rice Lake, Wisconsin 54868
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10 Woodland Rd
Saint Helena, California 94574
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Saint Louis, Missouri 63136
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557 Brookdale Dr
Statesville, North Carolina 28677
(704) 873-5661
Iredell Memorial Hospital Welcome to Iredell Health System, where you'll receive quality healthcare with personal...
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Stevens Point, Wisconsin 54481
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Stevens Point, Wisconsin 54481
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Tacoma, Washington 98431
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3501 Cranberry Blvd
Weston, Wisconsin 54476
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1000 E. Mountain Blvd.
Wilkes-Barre, Pennsylvania 18711
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Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center The Frank...
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