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A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Study of Combination Rituximab-CHOP and Bortezomib (Velcade®) (R-CHOP-V) Induction Therapy Followed by Bortezomib Maintenance (VM) Therapy for Patients With Newly Diagnosed Mantle Cell Lymphoma



- Determine the 2-year progression-free survival rate in patients with newly diagnosed
mantle cell lymphoma treated with induction therapy comprising rituximab,
cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and bortezomib
followed by bortezomib maintenance (VM) therapy.


- Determine the response rate (complete, complete unconfirmed, and partial responses) in
patients treated with this regimen.

- Determine the toxicity of VM in these patients.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive R-CHOP-V induction therapy comprising rituximab IV
over ≤ 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin hydrochloride IV
over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1; oral prednisone once
daily on days 1-5; and bortezomib IV over 30-90 minutes on days 1 and 4. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. After completion of 6 courses, patients with stable disease or
better proceed to bortezomib maintenance therapy.

- Maintenance therapy: Beginning 3 months after completion of R-CHOP-V induction therapy,
patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3
months for up to 8 courses in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed periodically for 4 years and then
annually for 3 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria:

- Stage III-IV or bulky stage II disease

- Confirmation of positivity for the following phenotypes by immunohistochemistry
or flow cytometry:

- Cluster of differentiation antigen 19 (CD19) (or CD20)

- Cyclin D1 OR evidence of t(11;14) translocation by cytogenetic analysis or
fluorescent in situ hybridization

- Newly diagnosed, previously untreated disease

- Bidimensionally measurable disease by conventional techniques

- No nonmeasurable disease only

- Adequate tumor tissue from original diagnostic specimen available

- Tissue obtained by needle aspiration or cytology not allowed

- No clinical evidence of central nervous system (CNS) involvement by lymphoma

- Co-registration on protocols SWOG-8947 and SWOG-8819 is strongly encouraged


- Zubrod performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No peripheral neuropathy ≥ grade 2

- No hypersensitivity to bortezomib, boron, or mannitol

- No other prior malignancy except for adequately treated basal cell or squamous cell
skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for
which the patient is currently in complete remission, or any other cancer for which
the patient has been disease free for the past 5 years

- HIV negative


- No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma

- More than 14 days since prior investigational drugs

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)

Outcome Description:

Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause.

Outcome Time Frame:

0-2 years

Safety Issue:


Principal Investigator

Steven H. Bernstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 2006

Completion Date:

October 2015

Related Keywords:

  • Lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell



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Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
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Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Interlakes Oncology/Hematology PC Rochester, New York  14623
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Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
Southwest Medical Center Liberal, Kansas  67901
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
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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
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Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
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Doctors Hospital at Ohio Health Columbus, Ohio  43228
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Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
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Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Olympic Hematology and Oncology Bremerton, Washington  98310
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
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M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise, Idaho  83712-6297
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Legacy Emanuel Hospital and Health Center and Children's Hospital Portland, Oregon  97227
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Mount Carmel Health - West Hospital Columbus, Ohio  43222
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Poudre Valley Hospital Fort Collins, Colorado  80524
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
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St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Mecosta County Medical Center Big Rapids, Michigan  49307
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Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
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Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
Mercy Medical Center Springfield, Ohio  45504
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
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Kingsport, Tennessee  37662
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Danville Regional Medical Center Danville, Virginia  24541
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
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Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Reid Hospital & Health Care Services Richmond, Indiana  47374
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Associates in Womens Health, PA - North Review Wichita, Kansas  67208
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Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
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Great Falls Clinic - Main Facility Great Falls, Montana  59405
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Grant Medical Center Cancer Care Columbus, Ohio  43215
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Adventist Medical Center Portland, Oregon  97216
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland, Oregon  97210
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
Southwest Virginia Regional Cancer Center at Wellmonth Health Norton, Virginia  24273
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Rutherford Hospital Rutherfordton, North Carolina  28139
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Providence Cancer Center Anchorage, Alaska  99508
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
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