Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated High- or High-Intermediate-Risk Diffuse Large B-Cell Lymphoma

Withdrawn before enrolling · Phase 2

Conditions studied: Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma

In brief

This phase II trial studies how well giving rituximab together with combination chemotherapy works in treating patients with previously untreated high- or high-intermediate-risk diffuse large B-cell lymphoma (DLBCL). Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells. Giving rituximab together with combination chemotherapy together may be an effective treatment for DLBCL

Key facts

Study ID: NCT01539174
Run by: Fox Chase Cancer Center
People needed: 0
Last updated by the study team: 2016-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Newly diagnosed cluster of differentiation (CD) 20+ DLBCL with IPI between 3-5
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%

You may not qualify if…

Women who are pregnant or breast feeding
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

Where it is running

Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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