Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:1/27/2019
Start Date:December 2010
End Date:April 2023

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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

RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different
ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of
cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies,
such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells
from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab
together alone is more effective than giving bendamustine hydrochloride and rituximab
together with bortezomib or lenalidomide in treating follicular lymphoma.

PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and
rituximab together with or without bortezomib followed by rituximab with or without
lenalidomide to see how well they work in treating patients with high-risk stage II, stage
III, or stage IV 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.

DISEASE CHARACTERISTICS:

- Histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin
lymphoma with no evidence of transformation to large cell histology

- Patients having both diffuse and follicular architectural elements are eligible
if the histology is predominantly follicular (i.e., ≥ 50% of the cross-sectional
area) and there is no evidence of transformation to a large cell histology

- Diagnostic confirmation (i.e., core needle or excisional lymph node biopsy)
required if the interval since tissue diagnosis of low-grade malignant lymphoma
is > 24 months

- Bone marrow biopsy alone not acceptable

- Stage II, III, or IV AND grade 1, 2, or 3a disease

- Must meet criteria for High Tumor Burden (higher risk) as defined by either the Groupe
D'Etude des Lymphomes Follicularies (GELF) criteria OR the follicular lymphoma
international prognostic index (FLIPI) as defined below:

- Patient must meet ≥ 1 of the following GELF criteria:

- Nodal or extranodal mass ≥ 7 cm

- At least 3 nodal masses > 3.0 cm in diameter

- Systemic symptoms due to lymphoma or B symptoms

- Splenomegaly with spleen > 16 cm by CT scan

- Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal)
or pleural or peritoneal serous effusion due to lymphoma (irrespective of
cell content)

- Leukemic presentation (≥ 5.0 x 10^9/L malignant circulating follicular
cells)

- Cytopenias (polymorphonuclear leukocytes < 1.0 X 10^9/L, hemoglobin < 10
g/dL, and/or platelets < 100 x 10^9/L)

- Patient must have a FLIPI-1 score of 3, 4, or 5 (1 point per criterion below):

- Age ≥ 60 years

- Stage III-IV disease

- Hemoglobin level < 12 g/dL

- > 4 nodal areas

- Serum LDH level above normal

- At least 1 objective measurable disease parameter

- Baseline measurements and evaluations (PET and CT) obtained within 6 weeks of
randomization

- Measurable disease in the liver is required if the liver is the only site of
lymphoma

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- ECOG performance status 0-2

- ANC ≥ 1,500/mm³ (includes neutrophils and bands)

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 2.0 mg/dL

- AST and ALT ≤ 5 x upper limit of normal (ULN)

- Alkaline phosphatase ≤ 5 x ULN

- Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert disease should contact the
study PI)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 effective methods (1 highly effective and 1 additional
effective method) of contraception ≥ 28 days before, during, and for ≥ 28 days after
completing study treatment

- HIV-positive patients must meet all of the following criteria:

- HIV is sensitive to antiretroviral therapy

- Must be willing to take effective antiretroviral therapy if indicated

- No history of CD4 < 300 cells/mm³ prior to or at the time of lymphoma diagnosis

- No history of AIDS-defining conditions

- If on antiretroviral therapy, must not be taking zidovudine or stavudine

- Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP)
during therapy and ≥ 2 months following completion of study therapy or until the
CD4 cells recover to over 250 cells/mm³

- No recent history of malignancy except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
been disease-free for ≥ 2 years

- No active, uncontrolled infections (afebrile for > 48 hours off antibiotics)

- No ≥ grade 2 neuropathy

- No myocardial infarction within the past 6 months

- No NYHA class III-IV heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active
conduction system abnormalities

- No serious medical or psychiatric illness likely to interfere with participation in
this clinical study

- No known hypersensitivity to boron or mannitol

- No chronic carriers of hepatitis B virus (HBV) with positive hepatitis surface antigen
(HBsAg +)

- Patients with a prior history of HBV infection, but immune, with only IgG
hepatitis core antibody positive (HBcAb+), must receive antiviral prophylaxis
(e.g., lamivudine 100 mg po daily) for ≥ 1 week prior to course 1 and throughout
induction and continuation therapy and for ≥ 12 months after the last rituximab
dose

- Must register into the mandatory RevAssist® program and be willing and able to comply
with the requirements of RevAssist® (for patients randomized to arm III)

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma

- Prednisone or other corticosteroids used for non-lymphomatous conditions will not
be considered as prior chemotherapy

- A prior/recent short course (< 2 weeks) of steroids for symptom relief of
lymphoma-related symptoms is allowed
We found this trial at
227
sites
2000 N Boise Ave
Loveland, Colorado 80538
(970) 669-4640
McKee Medical Center Through the years, McKee has led the way in health care innovation....
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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185 S Orange Ave
Newark, New Jersey 07103
(973) 972-4300
UMDNJ-New Jersey Medical School NJMS is committed to educating humanistic, culturally competent physicians who will...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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1111 Duff Ave
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McFarland Clinic PC-William R Bliss Cancer Center The William R. Bliss Cancer Center at Mary...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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2000 Ogden Ave
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6701 N Charles St
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211 Saint Francis Drive
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160 S Adams St
Carthage, Illinois 62321
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1454 North County Road 2050
Carthage, Illinois 62321
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Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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1653 W. Congress Parkway
Chicago, Illinois 60612
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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303 East Superior Street
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Chippewa Falls, Wisconsin 54729
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2500 Metrohealth Dr
Cleveland, Ohio 44109
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
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5201 Harry Hines Blvd
Dallas, Texas 75235
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100 North Academy Avenue
Danville, Pennsylvania 17822
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
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1720 S. Bellaire Street Suite 701
Denver, Colorado 80222
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22101 Moross Rd
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900 W. Clairemont Ave.
Eau Claire, Wisconsin 54701
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6401 France Ave S
Edina, Minnesota 55435
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501 E. Hampden Ave.
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3401 Ludington St
Escanaba, Michigan 49829
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101 S Major St
Eureka, Illinois 61530
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820 4th St N
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1024 S Lemay Ave
Fort Collins, Colorado 80524
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550 Osborne Rd NE
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3315 N Seminary St
Galesburg, Illinois 61401
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Green Bay, Wisconsin 54301
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835 S Van Buren St
Green Bay, Wisconsin 54301
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2845 Greenbrier Rd
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Jackson, Michigan 49201
(517) 788-4800
Allegiance Health Allegiance Health is a community-owned and locally-governed health system in Jackson, Michigan. We...
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250 Doctors Ct
Johnson Creek, Wisconsin 53038
(920) 699-3500
UW Cancer Center Johnson Creek UW Cancer Center Johnson Creek is a collaboration between Fort...
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Johnson Creek, WI
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