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Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma

Phase 2
18 Years
Open (Enrolling)

Thank you

Trial Information

Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma


- Determine the time to treatment failure in patients with previously untreated mantle
cell lymphoma treated with rituximab and CHOP chemotherapy comprising prednisone,
cyclophosphamide, doxorubicin, and vincristine followed by yttrium Y 90 ibritumomab
tiuxetan (IDEC-Y2B8; yttrium Y 90 ZevalinĀ®).

- Determine the response rate in patients at the completion of rituximab and CHOP and the
incremental response rate after IDEC-Y2B8.

- Determine the toxicity of this regimen in these patients.

- Correlate serum rituximab levels with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

- CHOP chemotherapy and rituximab: Patients receive cyclophosphamide IV, doxorubicin IV,
vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5 (R + CHOP).
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity.

Patients who have responding or stable disease proceed to radioimmunotherapy.

- Radioimmunotherapy: Within 4-7 weeks after the completion of R + CHOP chemotherapy,
patients receive rituximab IV and an imaging dose of indium In 111 ibritumomab tiuxetan
IV over 10 minutes on day 1. Patients then undergo whole body gamma imaging scans
during the first day (2-24 hours) and the second or third day (48-72 hours) after
injection. In the absence of altered biodistribution, patients receive rituximab IV
followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 ZevalinĀ®) IV
over 10 minutes on day 8.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.

PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study within 2.8 years.

Inclusion Criteria


- Histologically confirmed mantle cell lymphoma with expression of bcl-1 and CD20

- Stage II-IV disease

- Measurable or evaluable disease

- Measurable disease defined as at least 1 bidimensionally measurable lesion at
least 2 cm by imaging scan

- A spleen at least 17 cm or having discrete filling defects by CT scan will
constitute evaluable disease provided that no explanation other than
lymphomatous involvement (e.g., portal hypertension or other liver disease) is

- No known CNS lymphoma



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months


- WBC greater than 2,500/mm^3*

- Platelet count greater than 100,000/mm^3* NOTE: *Unless due to disease in bone marrow


- Bilirubin less than 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)

- ALT and AST no greater than 2.5 times upper limit of normal (unless due to liver
involvement by lymphoma)


- Creatinine less than 2.0 mg/dL

- Calcium no greater than 11.5 mg/dL


- LVEF greater than 45%


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 year after study

- HIV negative

- No other malignancy except treated carcinoma in situ of the cervix or squamous cell
or basal cell skin cancer or any other surgically cured malignancy from which the
patient has been disease-free for at least 3 years

- No other concurrent serious medical condition or active infection that would preclude
ability to deliver standard prednisone, cyclophosphamide, doxorubicin, and
vincristine (CHOP) chemotherapy


Biologic therapy

- No prior immunotherapy


- No prior chemotherapy

Endocrine therapy

- Prior corticosteroids allowed provided the course was no more than 2 weeks in


- No prior radiotherapy


- Not specified

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mitchell R. Smith, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

November 2003

Completion Date:

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



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
CCOP - Duluth Duluth, Minnesota  55805
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Columbus Columbus, Ohio  43206
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Cancer Center at Tufts - New England Medical Center Boston, Massachusetts  02111
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
CCOP - Scott and White Hospital Temple, Texas  76508
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Veterans Affairs Medical Center - New York New York, New York  10010
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
CCOP - Oklahoma Tulsa, Oklahoma  74136
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
City of Hope Comprehensive Cancer Center Duarte, California  91010
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Midlands Cancer Center at Midlands Community Hospital Papillion, Nebraska  68128-4157
CCOP - Colorado Cancer Research Program, Incorporated Denver, Colorado  80224
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
Stanford Cancer Center at Stanford University Medical Center Stanford, California  94305
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham, Alabama  35294
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
NYU Cancer Institute at New York University Medical Center New York, New York  10016
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060
Swedish-American Regional Cancer Center Rockford, Illinois  61104-2315
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
MBCCOP-Our Lady of Mercy Cancer Center Bronx, New York  10466
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Veterans Affairs Medical Center - Gainesville Gainesville, Florida  32608-1197
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Burgess Health Center Onawa, Iowa  51040
Veterans Affairs Medical Center - Omaha Omaha, Nebraska  68105
CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale, Arizona  85259
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612