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Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Phase 3
18 Years
Open (Enrolling)

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Trial Information

Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma



- Compare the time to rituximab failure in patients with low tumor burden indolent
non-Hodgkin's lymphoma treated with rituximab scheduled vs rituximab retreatment.


- Compare the time to first cytotoxic therapy in patients treated with these regimens.

- Determine the rationale for beginning cytotoxic therapy, defined as chemotherapy,
radiotherapy, or radioimmunotherapy, in patients treated with these regimens.

- Compare the toxic effects associated with these regimens in these patients.

- Correlate response and duration of response in these patients with rituximab

- Compare the health-related quality of life, distress, psychological functioning,
physical well-being, and functional well-being of patients treated with these regimens.

- Compare the impact of differential treatment response (delayed time to rituximab
failure and/or time to first cytotoxic therapy) on quality of life, distress, and
psychological functioning in patients treated with these regimens.

- Determine, prospectively, the physical and functional well-being of patients during
treatment with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
histologic subtype (follicular vs other), age (under 60 vs 60 and over), and the time from
diagnosis (less than 1 year vs at least 1 year).

- Induction rituximab: Patients receive rituximab IV once a week for 4 weeks. Patients
are re-evaluated 9 weeks after the completion of induction rituximab. Patients with a
partial or complete response to induction rituximab are randomized to 1 of 2 treatment

- Arm I (retreatment rituximab): Patients receive rituximab IV once a week for 4 weeks
upon disease progression provided time to progression is more than 6 months.

- Arm II (scheduled rituximab): Patients receive a single dose of rituximab IV once every
13 weeks until disease progression and in the absence of unacceptable toxicity.

Quality of life is assessed after induction rituximab treatment and at 26, 39, 65, 117, 169,
and 221 weeks after randomization.

Patients are followed at least annually for 15 years from study entry.

PROJECTED ACCRUAL: A total of 389 patients will be accrued for this study within 45 months.

Inclusion Criteria


- Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following:

- Follicular grade 1 or 2

- Small lymphocytic

- Marginal zone (nodal)

- Marginal zone (splenic)

- Mucosa-associated lymphoid tissue (MALT)

- No evidence of transformation to a large cell histology

- Stage III or IV disease

- Must meet the following criteria for low tumor burden:

- No nodal or extranodal mass at least 7 cm

- Less than 3 nodal masses greater than 3 cm in diameter

- No systemic symptoms or B symptoms

- No splenomegaly greater than 16 cm by CT scan

- No evidence of risk of compression of a vital organ (i.e., ureteral or epidural)

- No leukemic phase with greater than 5,000/mm^3 circulating lymphocytes

- No cytopenias, defined as any of the following:

- Platelet count less than 100,000/mm^3

- Hemoglobin less than 10 g/dL

- Absolute neutrophil count less than 1,500/mm^3

- At least 1 objective measurable disease parameter

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



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- See Disease Characteristics

- Absolute neutrophil count at least 1,500/mm^3*

- Hemoglobin at least 10 g/dL*

- Platelet count at least 100,000/mm^3* NOTE: *Without growth factor and/or transfusion


- Bilirubin no greater than 2 times upper limit of normal (ULN) OR direct bilirubin
normal for patients with Gilbert's Syndrome

- AST/ALT no greater than 5 times ULN

- Hepatitis B surface antigen negative


- Creatinine no greater than 2 times ULN


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No uncontrolled active infection

- Afebrile for at least 48 hours off antibiotics

- No other malignancy within the past 2 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy

- See Radiotherapy

- No prior immunotherapy for lymphoma


- No prior chemotherapy for lymphoma

- No concurrent chemotherapy

Endocrine therapy

- Not specified


- No prior radiotherapy for lymphoma

- No concurrent radiotherapy

- No concurrent radioimmunotherapy


- Not specified

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Time to treatment failure

Safety Issue:


Principal Investigator

Brad S. Kahl, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

November 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



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McFarland Clinic, PC Ames, Iowa  50010
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Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Menorah Medical Center Overland Park, Kansas  66209
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Ochsner Health Center - Bluebonnet Baton Rouge, Louisiana  70809
Union Hospital Cancer Program at Union Hospital Elkton MD, Maryland  21921
Foote Memorial Hospital Jackson, Michigan  49201
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
St. Luke's Hospital Cancer Care Center Duluth, Minnesota  55805
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
St. Joseph Medical Center Kansas City, Missouri  64114
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis, Missouri  63141
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Frederick R. and Betty M. Smith Cancer Treatment Center Sparta, New Jersey  07871
Leo W. Jenkins Cancer Center at ECU Medical School Greenville, North Carolina  27834
Mary Rutan Hospital Bellefontaine, Ohio  43311
Christ Hospital Cancer Center Cincinnati, Ohio  45219
Grant Medical Center Cancer Care Columbus, Ohio  43215
Flower Hospital Cancer Center Sylvania, Ohio  43560
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
St. Luke's Cancer Network at St. Luke's Hospital Bethlehem, Pennsylvania  18015
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Reading, Pennsylvania  19612-6052
Guthrie Cancer Center at Guthrie Clinic Sayre Sayre, Pennsylvania  18840
Hematology and Oncology Associates of Northeastern Pennsylvania Scranton, Pennsylvania  18510
Susquehanna Cancer Center at Divine Providence Hospital Williamsport, Pennsylvania  17701
York Cancer Center at Apple Hill Medical Center York, Pennsylvania  17405
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Franciscan Cancer Center at St. Joseph Medical Center Tacoma, Washington  98405-3004
Center for Cancer Treatment & Prevention at Sacred Heart Hospital Eau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn Elkhorn, Wisconsin  53121
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Green Bay, Wisconsin  54311
Saint Joseph's Hospital Marshfield, Wisconsin  54449
Medical Consultants, Limited Milwaukee, Wisconsin  53215
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Saint Michael's Hospital Cancer Center Stevens Point, Wisconsin  54481
Marshfield Clinic - Wausau Center Wausau, Wisconsin  54401
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois  60612-9985
Aurora Sinai Medical Center Milwaukee, Wisconsin  53201-0342
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center Englewood, New Jersey  07631
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Rutherford Hospital Rutherfordton, North Carolina  28139
Easton Regional Cancer Center at Easton Hospital Easton, Pennsylvania  18042
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Martha Jefferson Hospital Cancer Care Center Charlottesville, Virginia  22901
Kinston Medical Specialists Kinston, North Carolina  28501
Resurrection Medical Center Chicago, Illinois  60631
St. Francis Hospital Evanston, Illinois  60202
Frederick Memorial Hospital Regional Cancer Therapy Center Frederick, Maryland  21701
Underwood Memorial Hospital Woodbury, New Jersey  08096
McLeod Regional Medical Center Florence, South Carolina  29501
Central Pennsylvania Hematology and Medical Oncology Associates, PC Lemoyne, Pennsylvania  17043
La Grange Memorial Hospital La Grange, Illinois  60525
Cedar Valley Medical Specialists, PC - West Ridgeway Avenue Waterloo, Iowa  50702
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Rockwood Clinic Cancer Treatment Center Spokane, Washington  99204-2967
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau, Wisconsin  54401
Jacobi Medical Center Bronx, New York  10461
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland, New Jersey  08360
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center Dubois, Pennsylvania  15801
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Desert Regional Medical Center Comprehensive Cancer Center Palm Springs, California  92262
Providence Medical Center Kansas City, Kansas  66112
Johnson County Radiation Therapy Overland Park, Kansas  66210
Berkshire Hematology Oncology, PC Pittsfield, Massachusetts  01201
Oncology Care Associates, PLLC Saint Joseph, Michigan  49085
Independence Regional Health Center Independence, Missouri  64050
Kansas City Cancer Center at St. Joseph's Medical Mall Kansas City, Missouri  64114
Parvin Radiation Oncology Kansas City, Missouri  64116
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center Kansas City, Missouri  64154
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Memorial Medical Center Modesto, California  95355
Elmhurst Memorial Hospital Elmhurst, Illinois  60126
Veterans Affairs Medical Center - Indianapolis Indianapolis, Indiana  46202
Hattiesburg Clinic, PA at Forrest General Hattiesburg, Mississippi  39401
Valley Hospital - Ridgewood Ridgewood, New Jersey  07450
Trinity CancerCare Center Minot, North Dakota  58701
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Riddle Memorial Hospital Cancer Center Media, Pennsylvania  19063
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
AnMed Cancer Center Anderson, South Carolina  29621
Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg, Pennsylvania  18301
Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center Upland, Pennsylvania  19013
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields Olympia Fields, Illinois  60461
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Center for Cancer Care at Goshen General Hospital Goshen, Indiana  46526
Augusta Oncology Associates - Walton Way Augusta, Georgia  30901
Provena St. Mary's Regional Cancer Center - Kankakee Kankakee, Illinois  60901
Hematology & Oncology Clinic Hattiesburg, Mississippi  39402
Frankford Hospital Cancer Center - Torresdale Campus Philadelphia, Pennsylvania  19114
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus Boca Raton, Florida  33486
Camino Medical Group - Treatment Center Mountain View, California  94040
Delnor Community Hospital - Geneva Geneva, Illinois  60134
Kaiser Permanente Capital Area Medical Group - Shady Grove Facility Rockville, Maryland  20850
Ephrata Cancer Center at Ephrata Community Hospital Ephrata, Pennsylvania  17522
Central Wisconsin Cancer Program at Agnesian HealthCare Fond du Lac, Wisconsin  54935
Richard G. Laube Cancer Center at ACMH Kittanning, Pennsylvania  16201
Clarian Arnett Cancer Care Lafayette, Indiana  47904
St. Agnes Hospital Cancer Center Baltimore, Maryland  21229
Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility Largo, Maryland  20774
Kaiser Permanente - Towson Lutherville, Maryland  21093
Kaiser Permanente Medical Center - Fair Oaks Fairfax, Virginia  22033
Langlade Memorial Hospital Antigo, Wisconsin  54409
MaineGeneral Medical Center - Waterville Waterville, Maine  04901
Upper Chesapeake Medical Center Bel Air, Maryland  21014
Carson Tahoe Cancer Center at Carson Tahoe Regional Medical Center Carson City, Nevada  89703
AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus Pomona, New Jersey  08240