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Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase II Trial of Rituximab in Combination With CHOP Chemotherapy in Patients With Previously Untreated Intermediate or High Grade Non-Hodgkin's Lymphoma


OBJECTIVES: I. Determine the rate of complete response and partial response in patients with
intermediate or high grade non-Hodgkin's lymphoma treated with rituximab plus
cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). II. Determine the
toxicity of this regimen in these patients. III. Determine the disease-free and overall
survival, time to response, and time to disease progression in patients treated with this
regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to the number of
risk factors (0-2 vs 3-5). Risk factors include age (no greater than 60 vs greater than 60),
tumor stage (II vs III or IV), number of extranodal sites (no more than 1 vs more than 1),
performance status (0-1 vs 2-4), and serum LDH level (no greater than normal vs greater than
normal). Patients receive rituximab IV on day 1; cyclophosphamide, doxorubicin, and
vincristine IV on day 3; and oral prednisone on days 3-7. Patients over 60 also receive
filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts
recover (all other patients receive G-CSF as secondary prophylaxis). Treatment continues
every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who respond receive 2 more courses. Patients who have no measurable disease after 6
courses receive rituximab IV once weekly for 4 consecutive weeks. This treatment continues
every 6 months for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients who have measurable disease after 6 courses of chemotherapy receive 2 more courses
for a maximum of 8 courses of CHOP, followed by maintenance therapy with rituximab (as
described above). Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade non-Hodgkin's
lymphoma Stage II, III, or IV disease B-cell where lymphoid cells are CD20 or CD19
positive No mantle cell, lymphoblastic, or peripheral T-cell non-Hodgkin's lymphoma
Measurable or evaluable disease No prior treatment for lymphoma No known CNS metastases 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: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 12 weeks Hematopoietic: Unless documented bone marrow disease:
Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic:
SGOT and SGPT no greater than 3 times upper limit of normal Bilirubin no greater than 1.5
mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of severe
heart disease, cardiomyopathy, or congestive heart failure LVEF normal by MUGA or
echocardiogram Other: Not pregnant or nursing Fertile patients must use effective
contraception No active infection as defined by: Clinical syndrome consistent with a viral
or bacterial infection (e.g., influenza, upper respiratory infection, urinary tract
infection) OR Fever with a clinical site of infection identified OR Microbiologically
documented infection, including, but not limited to, bacteremia or septicemia No known HIV
positivity No known sensitivity to E. coli derivatives (e.g., asparaginase, human insulin,
human growth hormone, interferon alfa-2b) No other prior malignancy within the past 5
years except surgically cured basal or squamous cell skin cancer or carcinoma in situ of
the cervix No psychiatric, addictive, or other disorder that may preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent
biologic therapy except epoetin alfa No white blood cell transfusions Chemotherapy: See
Disease Characteristics No concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: At least 2
weeks since prior major surgery Other: No other concurrent investigational therapy No
prophylactic antibiotics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Carol Brannan, BS, BSN

Investigator Role:

Study Chair

Investigator Affiliation:

Amgen

Authority:

United States: Federal Government

Study ID:

CDR0000067940

NCT ID:

NCT00005959

Start Date:

December 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult Burkitt lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved 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
  • contiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved 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
  • noncontiguous stage II adult Burkitt lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Henry Ford HospitalDetroit, Michigan  48202
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Oncology-Hematology Group of South FloridaMiami, Florida  33176
University of Tennessee, MemphisMemphis, Tennessee  38163
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Our Lady of Mercy Medical CenterBronx, New York  10466
Oncology/Hematology Care, Inc.Cincinnati, Ohio  45219
Maine Center for Cancer Medicine and Blood DisordersScarborough, Maine  04074
New Mexico Oncology-HematologyAlbuquerque, New Mexico  87102
HemOnCare, P.C.Brooklyn, New York  11235
Cancer and Blood Institute of the DesertRancho Mirage, California  92270
Hematology & Oncology Associates of VirginiaRichmond, Virginia  23226
Montgomery Cancer CenterMontgomery, Alabama  36106-3657
Southeast Florida Hematology-Oncology GroupFort Lauderdale, Florida  33308
Hematology-Oncology Associates, PAPensacola, Florida  32501
Hutchinson Clinic, P.A.Hutchinson, Kansas  67502
Hematology/Oncology Care Inc.Crestview Hills, Kentucky  41017
Associates in Oncology and HematologyRockville, Maryland  20850
North Shore Cancer CenterPeabody, Massachusetts  01960
Bond ClinicRolla, Missouri  65401
Midwest Hematology Oncology Consultants, Ltd.Saint Louis, Missouri  63136
Hematology Oncology AssociatesMorristown, New Jersey  07962
N.W. Carolina Oncology & Hematology, P.A.Hickory, North Carolina  28603
Intermountain Hematology/Oncology Associates, Inc.Salt Lake City, Utah  84124
Vermont Center for Cancer Medicine, Inc.Colchester, Vermont  05446