Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/15/2018
Start Date:August 27, 2013

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Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs. RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma

This randomized phase II trial studies how well rituximab and combination chemotherapy with
or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse
large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the
ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as
cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, 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. Lenalidomide may stimulate the immune
system in different ways and stop cancer cells from growing. It is not yet known whether
rituximab and combination chemotherapy are more effective when given with or without
lenalidomide in treating patients with diffuse large B cell lymphoma.

PRIMARY OBJECTIVES:

I. Progression-free survival (PFS).

SECONDARY OBJECTIVES:

I. Response rate (RR). II. Complete remission (CR) rate as defined by positron emission
tomography (PET)-computed tomography (CT) criteria.

III. Overall survival (OS).

TERTIARY OBJECTIVES:

I. Impact of diffuse large B cell lymphoma (DLBCL) molecular subtype on outcome.

II. Interim PET scan results in relation to treatment outcome.

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

ARM A: Patients receive rituximab intravenously (IV), cyclophosphamide IV, doxorubicin
hydrochloride IV, and vincristine sulfate IV on day 1; prednisone orally (PO) on days 1-5;
and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the
absence of disease progression or unacceptable toxicity.

ARM B: Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine
sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 1 year, and then annually for up to 7 years.

Inclusion Criteria:

- PRE-REGISTRATION (STEP 0)

- Histologically confirmed DLBCL expressing CD20 antigen; patients with transformed
lymphoma are excluded; in this regard, patients with composite lymphoma in the
diagnostic tissue (concomitant DLBCL and follicular or other low-grade lymphoma
component) are excluded; however, patients with DLBCL in primary diagnostic tissue but
a bone marrow that shows low grade or indeterminate lymphoma are eligible; patients
with known primary mediastinal large B-cell lymphoma (PMLBCL) are excluded; similarly,
patients with known c-myc translocation (by fluorescence in situ hybridization)
positive DLBCL are encouraged to participate in trials specifically designed for these
patients; however patients with known c-myc DLBC positive are NOT excluded from this
study; c-myc testing prior to study enrollment is NOT required

- Stages II bulky disease (defined as mass size of more than 10 cm), stage III, or IV
(Ann Arbor staging); patients with stage I and stage II non-bulky disease are excluded
from this study

- A paraffin-embedded tumor tissue specimen from the initial diagnostic biopsy has been
located and ready to ship to the Mayo Clinic Lymphoma Laboratory following
pre-registration; Note: excisional tumor biopsy is preferred; core needle biopsies
will be considered adequate if there is enough tissue for the mandatory central
pathology review immunohistochemistry and Genomics Education Partnership (GEP);
submission of a tumor block is preferred, but if unavailable submit alternative
materials

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Previously untreated and not receiving any other agent that would be considered as a
treatment for the lymphoma; for subjects with severe systemic symptoms, compressive
disease, or rapidly progressing symptomatic adenopathy, are allowed for lymphoma
associated symptom treatment with up to 1 mg/kg/day prednisone, or equivalent, for a
maximum of 7 days is permitted prior to beginning the treatment, at the discretion of
the investigator; a washout period does not apply

- No known central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with
malignant lymphoma cells; these patients are usually treated with CNS directed
therapy; screening for cerebrospinal fluid (CSF)/CNS involvement is NOT required but
can be performed per treating medical doctor (MD) discretion; intrathecal (IT)
methotrexate or IT cytarabine prophylaxis in patients with negative CSF who are felt
to be at high risk of CNS relapse is allowed per local MD discretion; this should be
noted on the treatment form

- Absence of history of myocardial infarction =< 6 months, or congestive heart failure
requiring use of ongoing maintenance therapy for life-threatening ventricular
arrhythmias

- Absence of history of deep venous thrombosis/embolism, threatening thromboembolism or
known thrombophilia; patients with a history of deep vein thrombosis(DVT)/pulmonary
embolism (PE) or thrombophilia may participate if they are willing to be on full
anticoagulation during the treatment if randomized to rituximab, cyclophosphamide,
doxorubicin hydrochloride, vincristine sulfate, and prednisone (R2CHOP) arm A; full
anticoagulation is defined as warfarin, factor X inhibitors, or low molecular weight
heparin at therapeutic doses

- Patient must be able and willing to receive anticoagulation therapy with aspirin
70-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or
warfarin; patients unable or unwilling to take any prophylaxis are NOT eligible

- Absence of history of acquired immune deficiency syndrome (AIDS)-related conditions
(other than the presenting DLBCL) or post-transplant lymphoproliferative disorder
(PTLD) in immunocompromised patients; patients with human immunodeficiency virus (HIV)
on antiretroviral therapy other than zidovudine (AZT) and/or stavudine and without
prior AIDS defining conditions and adequate CD4 count (> 400) are eligible

- No other active malignancy requiring therapy such as radiation, chemotherapy, or
immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer
and any cancer that in the judgment of the investigator has been treated with curative
intent and will not interfere with the study treatment plan and response assessment

- No history of radiation therapy to >= 25% of the bone marrow for other diseases or
history of anthracycline therapy

- Patients must not be receiving erythroid stimulating agents (EPO: Procrit, Aranesp)

- RANDOMIZATION (STEP 1)

- Patient meets the eligibility criteria outlined above

- Site has received notification from Mayo Clinic - Rochester Division of
Hematopathology of the central confirmation of diagnosis and tissue adequacy for
mandatory research studies

- Patients must have measurable disease (at least 1 lesion of >= 1.5 cm in one diameter)
as detected by computed tomography (CT) or the CT images of the positron emission
tomography (PET)/CT

- International Prognostic Index (IPI) of 2 or greater

- Ejection fraction of >= 45% by either multi-gated acquisition (MUGA) scan or
echocardiogram (ECHO)

- Absence of co-morbid systemic illnesses or other severe concurrent disease which, in
the judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens, including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Absolute neutrophil count (ANC) >= 1500

- Platelets (PLT) >= 100,000

- Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x
ULN, the direct bilirubin must be normal

- Alkaline (Alk.) phosphatase =< 3 x ULN unless evidence of the direct liver involvement
by lymphoma - then =< 5 x ULN

- Aspartate aminotransferase (AST) =< 3 x ULN unless evidence of the direct liver
involvement by lymphoma - then =< 5 x ULN

- Creatinine =< 2 x ULN or creatinine clearance (CrCl) > 30 ml/min

- Women must not be pregnant or breast-feeding

- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again
within 24 hours of starting lenalidomide and must either commit to continued
abstinence from heterosexual intercourse or begin TWO acceptable methods of birth
control, one highly effective method and one additional effective method AT THE SAME
TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to
ongoing pregnancy testing; a female of childbearing potential is any woman, regardless
of sexual orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or
2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has
had menses at any time in the preceding 24 consecutive months)

- Men must agree to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy; all patients must be counseled at a minimum of every
28 days about pregnancy precautions and risks of fetal exposure
We found this trial at
514
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424 Savannah Rd
Lewes, Delaware 19958
(302) 645-3300
Principal Investigator: Gregory A. Masters
Phone: 302-733-6227
Beebe Medical Center Located in beautiful historic Lewes, Delaware, near Rehoboth Beach, Beebe Healthcare offers...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
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Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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800 Washington St
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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
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3551 Roger Brooke Dr
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2500 N State St
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200 North Park Street
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1800 West Charleston Boulevard
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777 Hemlock Street
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4805 Northeast Glisan Street
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60 Crittenden Blvd # 70
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3900 W Avera Drive
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Akron, Ohio 44304
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1 Akron General Avenue
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Allentown, Pennsylvania 18103
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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1500 East Medical Center Drive
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Antigo, Wisconsin 54409
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Antioch, California 94531
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Appleton, Wisconsin 54913
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
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Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Auburn, California 95602
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Aurora, Colorado 80012
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
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Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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1500 Red River Street
Austin, Texas 78701
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Baldwin Park, California 91706
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Lode J. Swinnen
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489 State St
Bangor, Maine 04401
(207) 973-7000
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Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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155 5th St NE
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4305 New Shepherdsville Road
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Baton Rouge, Louisiana 70809
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
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Bellflower, California 90706
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
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300 N. Seventh St.
Bismarck, North Dakota 58501
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
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Boise, Idaho 83706
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100 E Idaho St
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(208) 381-2711
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Bolivar, Missouri 65613
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Boston, Massachusetts 02118
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
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Brewer, Maine 04412
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
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Burlington, Wisconsin 53105
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Principal Investigator: Joseph W. Leach
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400 South Clark Street
Butte, Montana 59701
406-723-2500
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
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Canton, Ohio 44708
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
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3110 MacCorkle Avenue Southeast
Charleston, West Virginia 25304
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232 S Woods Mill Rd
Chesterfield, Missouri 63017
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Chicago, Illinois 60611
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Chicago, Illinois 60657
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Chicago, Illinois 60640
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Cincinnati, Ohio 45220
Principal Investigator: Mehmet S. Copur
Phone: 800-998-2119
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Cincinnati, Ohio 45247
Principal Investigator: Mehmet S. Copur
Phone: 800-998-2119
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Cincinnati, Ohio 45255
Principal Investigator: Mehmet S. Copur
Phone: 800-998-2119
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Cincinnati, Ohio 45219
Principal Investigator: Stephen C. Medlin
Phone: 513-558-4553
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Clackamas, Oregon 97015
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Alison K. Conlin
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clackamas, OR
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Paolo F. Caimi
Phone: 800-641-2422
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Bruce J. Averbook
Phone: 216-778-8526
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Clinton, North Carolina 28328
Principal Investigator: James N. Atkins
Phone: 919-580-0000
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Clinton, NC
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Clive, Iowa 50325
Principal Investigator: Mehmet S. Copur
Phone: 800-998-2119
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Clive, IA
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12495 University Ave
Clive, Iowa 50325
(515) 358-9700
Principal Investigator: Mehmet S. Copur
Phone: 800-998-2119
Mercy Cancer Center - West Lakes When it comes to cancer care, there
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Clive, IA
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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Colorado Springs, Colorado 80907
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Columbus, Ohio 43210
Principal Investigator: Kami J. Maddocks
Phone: 800-293-5066
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Columbus, Ohio 43222
Principal Investigator: John P. Kuebler
Phone: 614-488-2745
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810 Jasonway Avenue
Columbus, Ohio 43214
614/442-3130
Principal Investigator: John P. Kuebler
Phone: 614-488-2745
Columbus Oncology and Hematology Associates Inc Columbus Oncology and Hematology Associates is a group of...
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Principal Investigator: John P. Kuebler
Phone: 614-488-2745
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
Principal Investigator: John P. Kuebler
Phone: 614-488-2745
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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