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Phase III Trial of CHOP Versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients With Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma


Phase 3
60 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase III Trial of CHOP Versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients With Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma


OBJECTIVES: I. Compare the efficacy of CHOP (cyclophosphamide, doxorubicin, vincristine, and
prednisone) with or without rituximab in older patients with diffuse mixed, diffuse large,
or immunoblastic large cell non-Hodgkin's lymphoma of B-cell lineage with respect to the
response rate, time to treatment failure, toxicity, and survival. II. Compare the efficacy
of maintenance therapy consisting of rituximab vs observation alone after initial therapy
with respect to the time to treatment failure, duration of response, toxicity, and survival
of this patient population. III. Determine if maintenance therapy with rituximab results in
the conversion of any partial response to complete response.

OUTLINE: This is a randomized study. For the first randomization, patients are stratified
according to the number of risk factors (0-1 vs 2-4). For the second randomization, in
addition to the number of risk factors, patients are stratified according to objective
response to initial induction therapy (partial response vs complete response) and induction
therapy (CHOP vs CHOP and rituximab). Patients are randomized to one of two treatment arms.
Arm I: Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin IV,
and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days
in the absence of unacceptable toxicity. Arm II: Patients receive treatment as in arm I.
Patients also receive rituximab IV on days -7,-3, 41, and 83. Patients who achieve complete
response (CR) after 4 courses of CHOP and remain in CR after 6 courses of CHOP are further
randomized to one of two arms. Arm I (Maintenance therapy): Patients receive rituximab IV
weekly for 4 weeks. Courses repeat every 6 months for 2 years in the absence of unacceptable
toxicity. Arm II: Patients are observed. Patients who achieve partial response (PR) after 6
courses OR PR after 4 courses and then CR after 6 courses receive 2 additional courses of
CHOP therapy. Patients are then also randomized to receive either maintenance therapy or
observation as above. Patients with stable disease or disease progression are removed from
the study. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and
then annually thereafter.

PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven intermediate or high grade B-cell
non-Hodgkin's lymphoma (other than Burkitt's, non-Burkitt's, undifferentiated, or
lymphoblastic lymphoma) B-cell non-Hodgkin's lymphoma positive for CD19 and/or CD20 by
slide-based immunohistochemistry or flow cytometry No mantle cell or follicular lymphoma
Measurable disease, defined by at least one of the following: Physical examination
Radiographic findings of at least 2 dimensions Bidimensional measurable defect or mass
measuring at least 2 cm in diameter on radionuclide or CT scan Enlarged spleen extending
at least 2 cm below the costal margin provided that there is no other likely explanation
besides lymphomatous involvement Enlarged liver extending at least 5 cm below the costal
margin along with biopsy-proven lymphomatous hepatic involvement No history of transformed
lymphoma No known posttransplantation lymphoproliferative disorder No CNS involvement
CALGB patients 60-65 years of age must not be eligible for any other study of higher
priority A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by
PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol
uses the former terminology.

PATIENT CHARACTERISTICS: Age: See Disease Characteristics 60 and over Performance status:
ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least
1,500/mm3 (unless due to lymphoma) Platelet count greater than 100,000/mm3 (unless due to
lymphoma) Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine less than 2.1
mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active heart disease
including congestive heart failure, myocardial infarction within the past 3 months, or
symptomatic ventricular arrhythmia LVEF at least 45% if prior history of heart disease
exists Other: HIV negative No other malignancy within the past 5 years except squamous
cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior biologic
response modifier therapy No prior immunotherapy No prior rituximab Chemotherapy: No prior
cytotoxic chemotherapy No concurrent dexrazoxane Endocrine therapy: Prior corticosteroids
allowed Radiotherapy: No prior radiotherapy No prior radioimmunotherapy Surgery: Not
specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Thomas M. Habermann, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000065935

NCT ID:

NCT00003150

Start Date:

December 1997

Completion Date:

September 2006

Related Keywords:

  • Lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - DuluthDuluth, Minnesota  55805
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer CenterPortland, Oregon  97201-3098
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Hematology Oncology AssociatesAtlantis, Florida  33462