Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma



Status:Recruiting
Conditions:Lymphoma, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:60 - 120
Updated:4/21/2016
Start Date:May 2012

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Intergroup Randomized Phase 2 Four Arm Study In Patients ≥ 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)

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

PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and
lenalidomide in treating previously untreated older patients with mantle cell lymphoma.

OBJECTIVES:

Primary

- To determine whether the addition of bortezomib (RBV) to an induction regimen of
rituximab-bendamustine hydrochloride (RB) improves progression-free survival (PFS)
compared to RB alone in patients ≥ 60 years of age with previously untreated mantle
cell lymphoma.

- To determine whether the addition of lenalidomide to a consolidation regimen of
rituximab following an induction regimen of RB or RBV improves PFS compared to
consolidation rituximab alone in this patient population.

Secondary

- To determine whether the addition of bortezomib to induction therapy improves the
positron emission tomography (PET)-documented complete response (CR) rate compared to
RB alone.

- To determine the objective response rate (ORR) for RB and RBV.

- Among patients who do not have PET-documented CR at the end of induction, to determine
whether the addition of lenalidomide to consolidation therapy improves CR and ORR
compared with rituximab alone.

- To determine overall survival (OS) in the treatment arms.

- To determine safety, with attention to the addition of bortezomib in the induction
regimen and lenalidomide-rituximab (LR) as consolidation therapy.

- To collect paraffin-embedded tissue for creation of tissue microarray.

- To collect and bank serum and blood mononuclear cells for future studies.

- To collect formalin-fixed paraffin-embedded (FFPE) tissue to analyze potential
prognostic factors (Ki-67 proliferation index by immunohistochemistry and correlation
with proposed 5-gene set of proliferation markers analyzed by RNA PCR; SOX 11
expression by immunohistochemistry; and Micro-RNA levels by microarray).

- Using patient-reported outcomes data, to determine the extent and severity of
neuropathy associated with the addition of bortezomib to induction treatment.

- Using patient-reported outcomes data, to determine the extent and severity of fatigue
associated with the addition of lenalidomide to consolidation treatment.

- To evaluate the effects of the addition of bortezomib and lenalidomide on
patient-reported health-related quality of life.

- To evaluate the effects of bortezomib-related neuropathy on patient-reported
health-related quality of life.

- To evaluate the response of lymphoma-specific symptoms to treatment.

- Using longitudinal patient-reported outcomes data, to describe the trajectory of
lymphoma symptoms, neuropathy, fatigue, and overall health-related quality of life
prior to, during, and following treatment among older adults with MCL.

Tertiary

- To assess the proportion of patients up and down staging when fludeoxyglucose F 18-
(FDG) PET/CT is added to standard Ann Arbor staging.

- To assess the ability of pre-treatment FDG-PET/CT (SUVmax) to predict response rate and
PFS.

- Among patients with interim (post-cycle 3) FDG-PET/CT imaging, to assess the
correlation of interim FDG-PET/CT imaging with response rate and PFS both during
induction and consolidation therapy.

- To assess standard FDG-PET/CT metrics including SUVmax, tumor metabolic burden, total
tumor burden, and association with pathology features (blastoid variant vs other, and
Ki67) in the setting of MCL.

- To assess differences in overall and CR rates when using Deauville vs International
Harmonization Project FDG-PET/CT interpretation criteria.

- To determine whether there is a correlation between FDG-PET/CT response and residual
disease assessment by molecular and/or flow cytometric techniques.

- To determine whether the number of malignant cells in circulation predict the number of
cells in marrow.

- To determine whether the number of malignant cells in circulation/in marrow at the end
of induction correlate with CR and 2-year PFS.

- To determine whether there is a higher rate of minimal residual disease (MRD)
negativity among patients randomized to RBV as compared with RB, and among patients
treated with LR maintenance compared with rituximab.

- To compare the two methods of MRD detection - molecular techniques and flow cytometry -
as prognostic markers for outcome.

OUTLINE: This is a multicenter study. Patients are stratified according to mantle cell
lymphoma International Prognostic Index risk score (low vs intermediate vs high). Patients
are randomized to 1 of 4 treatment arms.

- Arm A: Patients receive induction therapy comprising rituximab IV on day 1 and
bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4
weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

- Arm E: Patients receive consolidation therapy comprising rituximab IV on day 1.
Courses repeat every 8 weeks for 2 years in the absence of disease progression or
unacceptable toxicity.

- Arm B: Patients receive induction therapy comprising bortezomib IV or subcutaneously
(SC) on days 1, 4, 8, and 11 and rituximab and bendamustine hydrochloride as patients
in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.

- Arm F: Patients receive consolidation therapy comprising rituximab IV on day 1.
Courses repeat every 8 weeks for 2 years in the absence of disease progression or
unacceptable toxicity.

- Arm C: Patients receive induction therapy comprising rituximab and bendamustine
hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in
the absence of disease progression or unacceptable toxicity.

- Arm G: Patients receive consolidation therapy comprising lenalidomide orally (PO)
daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the
absence of disease progression or unacceptable toxicity.

- Arm D: Patients receive bortezomib, rituximab, and bendamustine hydrochloride as
patients in arm B. Treatment repeats every 4 weeks for 6 courses in the absence of
disease progression or unacceptable toxicity.

- Arm H: Patients receive consolidation therapy comprising lenalidomide PO daily on
days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence
of disease progression or unacceptable toxicity.

Patients may undergo blood and bone marrow sample collection at baseline and during
treatment for correlative studies.

Patients complete the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym), the
FACT/GOG-Neurotoxicity scale (FACT/GOG-Ntx), FACT-Fatigue, and FACT-General questionnaires
at baseline and periodically during study and follow up.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually for 10 years.

DISEASE CHARACTERISTICS:

- Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin
D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in
situ hybridization (FISH)

- Patients must have at least one objective measurable disease parameter

- Abnormal PET scans will not constitute evaluable disease, unless verified by CT
scan or other appropriate imaging

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

- Patient must have no CNS involvement

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- ANC ≥ 1,500/mcL (1.5 x 10^9/L)*

- Platelets ≥ 100,000/mcL (100 x 10^9/L)* NOTE: *Unless due to marrow involvement.

- AST/ALT ≤ 2 times upper limit of normal (ULN)

- Bilirubin ≤ 2 times ULN

- Calculated creatinine clearance by Cockroft-Gault formula ≥ 30 mL/min

- Women (sexually mature female) must not be pregnant or breast-feeding

- Negative pregnancy test

- Women of childbearing potential and sexually active males use an accepted and
effective method of contraception

- Men must agree to use a latex condom during sexual contact with a female of
child-bearing potential, 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

- No evidence of prior malignancy except adequately treated non-melanoma skin cancer,
in situ cervical carcinoma, or any surgically or radiation-cured malignancy
continuously disease free for ≥ 5 years so as not to interfere with interpretation of
radiographic response

- Patient agrees that if randomized to Arms C or D, and proceed onto Arms G or H, they
must register into the mandatory RevAssist® program, and be willing and able to
comply with the requirements of RevAssist®

- Patients must have no medical contra-indications to, and be willing to take,
deep vein thrombosis (DVT) prophylaxis as all patients registering to the
lenalidomide/rituximab Arms G and H will be required to have DVT prophylaxis

- Patients randomized to Arms G or H who have a history of a thrombotic
vascular event will be required to have therapeutic doses of low-molecular
weight heparin or warfarin to maintain an INR between 2.0 - 3.0

- Patients on Arms G and H without a history of a thromboembolic event are
required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis

- Patients who are unable to tolerate aspirin should receive low
molecular weight heparin therapy or warfarin treatment

- Women must agree to abstain from donating blood during study participation and
for at least 28 days after discontinuation from protocol treatment

- Males must agree to abstain from donating blood, semen, or sperm during study
participation and for at least 28 days after discontinuation from protocol
treatment

- HIV-positive patients are not excluded but, to enroll, must meet all of the below
criteria:

- HIV is sensitive to antiretroviral therapy

- Must be willing to take effective antiretroviral therapy, if indicated

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

- 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 until at least 2 months following the completion of therapy
or until the CD4 cells recover to over 250 cells/mm³, whichever occurs later

- Patients must not have grade 2 or greater peripheral neuropathy

- Patients must not have NYHA Class III or IV heart failure, uncontrolled angina,
severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of
acute ischemia

- Patients must not have hypersensitivity to bortezomib, boron, or mannitol

- Patients must not have a serious medical or psychiatric illness likely to interfere
with study participation

PRIOR CONCURRENT THERAPY:

- No prior therapy for MCL, except < 1 week of steroid therapy for symptom control

- HIV-positive patients are not excluded, but to enroll, must meet all of the below
criteria:

- Must be willing to take effective antiretroviral therapy if indicated

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

- Patients must not be participating in any other clinical trial or taking any other
experimental medications within 14 days prior to registration
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Saint Luke's Hospital St. Luke's Hospital, located in Chesterfield, Missouri, is a regional healthcare provider...
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
Principal Investigator: Luis D. Sumoza Benitez
Phone: 312-864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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Chicago, IL
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Chicago, Illinois 60608
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Chicago, IL
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676 N St Clair St #2140
Chicago, Illinois 60611
(312) 664-5400
Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
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Chicago, IL
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Jane N. Winter
Phone: 312-695-1301
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Chicago, IL
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Stephen C. Medlin
Phone: 513-558-4553
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Cincinnati, Ohio 45242
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45230
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45236
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45219
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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Cincinnati, Ohio 45211
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Cincinnati, OH
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Alison K. Conlin
Phone: 503-215-6412
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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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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Cleveland, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Anjali S. Advani
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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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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Cleveland, OH
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Principal Investigator: Anjali S. Advani
Phone: 866-223-8100
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
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Cleveland, OH
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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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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
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Cody, WY
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
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Cody, WY
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Principal Investigator: Keren Sturtz
Phone: 888-785-6789
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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Colorado Springs, CO
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Colorado Springs, Colorado 80907
Principal Investigator: Keren Sturtz
Phone: 888-785-6789
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Colorado Springs, CO
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1 Hospital Dr
Columbia, Missouri 65212
(573) 882-2100
Principal Investigator: Donald C. Doll
Phone: 573-882-7440
University of Missouri-Ellis Fischel Ellis Fischel Cancer Center's team of physician specialists and other trained...
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Columbia, MO
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300 W 10th Ave
Columbus, Ohio 43210
(800) 293-5066
Principal Investigator: Kristie A. Blum
Phone: 800-293-5066
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center...
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Columbus, OH
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: Joseph W. Leach
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Coon Rapids, MN
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Crestview Hills, Kentucky 41017
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Crestview Hills, KY
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5201 Harry Hines Blvd
Dallas, Texas 75235
(214) 590-8000
Parkland Memorial Hospital As our community's public health system, Parkland is the foundation for a...
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Dallas, TX
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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Danville, Illinois 61832
Principal Investigator: Maria T. Grosse-Perdekamp
Phone: 800-446-5532
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Danville, IL
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Edward J. Gorak
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Dayton, OH
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405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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Dayton, OH
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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