Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated High- or High-Intermediate-Risk Diffuse Large B-Cell Lymphoma
NCT ID: NCT01539174
Last Updated: 2016-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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I. To evaluate 1 year progression-free survival (PFS) following treatment with rituximab intense dosing and CHOP-21 (RID-CHOP) in previously untreated patients with high risk (International Prognostic Index \[IPI\] 3-5) DLBCL.
SECONDARY OBJECTIVES:
I. To evaluate, in previously untreated patients with high risk (IPI 3-5) DLBCL treated with rituximab intense dosing and CHOP-21: Complete response (CR) rate, (as defined by International Harmonization Project criteria using 18-fluorodeoxyglucose \[FDG\] -positron emission tomography \[PET\]/computed tomography \[CT\]).
II. Overall survival.
III. Toxicity profile.
IV. Rituximab pharmacokinetics for this dose and schedule.
V. Effect of immunophenotype of DLBCL on outcome.
VI. Effect of Fc-Gamma Receptor III (FcyRIII) polymorphism genotype on outcome. OUTLINE: Patients receive rituximab intravenously (IV) on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone orally (PO) on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-3 months for 2 years, every 6 months for 3 years, annually for up to 10 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (monoclonal antibody, combination chemotherapy)
Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
rituximab
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
vincristine sulfate
Given IV
prednisone
Given PO
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Interventions
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rituximab
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
vincristine sulfate
Given IV
prednisone
Given PO
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior chemotherapy, radiation therapy or immunotherapy for DLBCL; a short course (\< 2 weeks) of corticosteroids is allowed for symptom control Signed informed consent
* Eastern Cooperative Oncology Group (ECOG) Performance status assessed between 0 and 2; performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated
* Measurable disease by Non-Hodgkin's Lymphoma Response Criteria on FDG-PET/CT; baseline measurements and evaluations must be obtained =\< 21 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,500/μL unless due to marrow involvement by lymphoma
* Platelets \>= 75,000/μL unless due to marrow involvement by lymphoma Hemoglobin \> 7.0 g/dL unless due to marrow involvement by lymphoma
* Creatinine =\< 2.0 mg/dL or calculated creatinine clearance \>= 40
* Total bilirubin =\< 1.5 mg/dL unless due to Gilbert's disease
* Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =\< 2.5 the upper limit of normal
* Alkaline phosphatase =\< 5x upper limit of normal
* Patients with bilirubin between 1.5-3.0 mg/dL due to lymphoma may be entered and doses adjusted
* Left ventricular ejection fraction (LVEF) \>= 50%
Exclusion Criteria
* Known seropositivity for human immunodeficiency virus (HIV)
* Known presence of central nervous system (CNS) involvement by lymphoma
* New York Heart Association Classification III or IV heart
* Current or chronic hepatitis B or hepatitis C infection (as detected by positive testing for Hepatitis B surface Antigen \[Hbs Ag\] or antibody to Hepatitis C virus \[anti HCV\] respectively); patients must be tested for Hepatitis B surface antigen and anti-HCV =\< 21 days prior to registration
* Male patients (with female sexual partners of childbearing potential) and female patients of childbearing potential who refuse to use effective methods of contraception
* Unstable or severe uncontrolled medical, psychological, or social condition
* Any evidence of serious active, uncontrolled infection (i.e., requiring an IV antibiotic or antiviral agent)
* Receipt of live vaccine within 4 weeks prior to study drug administration
* Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; subjects with previous malignancies are eligible provided that they have been treated with curative intent and remain disease free for 3 years or more
* No prior chemotherapy for lymphoma
* Prior radiation therapy for lymphoma
* Any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, significantly increase the subject's risk of participating in this study
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Fox Chase Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michael Millenson, MD, FACP
Role: PRINCIPAL_INVESTIGATOR
Fox Chase Cancer Center
Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2011-03309
Identifier Type: REGISTRY
Identifier Source: secondary_id
OER-HM-039
Identifier Type: -
Identifier Source: org_study_id
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