PHASE II STUDY OF DOSE-ADJUSTED EPOCH+/- RITUXIMAB IN ADULTS WITH UNTREATED BURKITT LYMPHOMA, c-MYC POSITIVE DIFFUSE LARGE BCELL LYMPHOMA AND PLASMABLASTIC LYMPHOMA
Michelle A. Fanale
The goal of this clinical research study is to learn if and how long etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab can help to control Burkitt lymphoma, aggressive c-myc positive diffuse large B-cell or Plasmablastic lymphoma. The safety of this drug combination will also be studied. Some participants may also receive methotrexate as part of the investigational therapy.
Disease Group: Malignant neoplasms stated as primary lymphoid haematopoietic
Treatment Agent: Cyclophosphamide,Doxorubicin,Etoposide,Prednisone,Rituximab,Vincristine
Treatment Location: Both at MDACC & and Other Sites
Primary Event-free survival (EFS) of risk adaptive dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide,doxorubicin and rituximab (DA-EPOCH-R) in newly diagnosed Burkitt Lymphoma (BL) and c-MYC(codes for a protein that binds to the DNA of other genes) + (diffuse large B-cell lymphoma) and DA-EPOCH in c-MYC+ plasmablastic lymphoma DLBCL >/= 18 years. Secondary 1. Assess predictive value of early fluoro-D-glucose positron emission tomography (FDG-PET) scans on PFS. 2. Obtain pilot comparative molecular profiling of human immunodeficiency virus (HIV) negative and positive BL c-MYC + DLBCL and c-MYC+ plasmablastic lymphoma. 3. Assess the toxicity of risk adaptive DA-EPOCH-R in newly diagnosed Burkitt Lymphoma c-MYC + DLBCL and DA-EPOCH in c-MYC+ plasmablastic lymphoma >/= 18 years.
IRB Review and Approval Date: 12/20/2011
Recruitment Status: Open
Projected Accrual: 194
1) Burkitt Lymphoma. Effective with Amendment J (version date:
06/24/2014), the following histologies were removed as the maximum
number allowed for these sub-groups has been reached: B-cell lymphoma:
unclassifiable with features intermediate between Diffuse Large B-cell
lymphoma and Burkitt Lymphoma ; c-MYC + DLBCL and c-MYC+ plasmablastic
lymphoma. If questions arise related to diagnosis, please contact the
NCI PI, Dr. Dunleavy or the NCI study coordinator, A. Nicole Lucas.
2) Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of EPOCH-R in patients < 18 years of age, children are excluded from this study, but may be eligible for future pediatric trials
3) Pathology confirmed by treating institution’s Pathology Department.
4) No prior treatment except patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids, cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture.
5) All disease stages.
6) Human immunodeficiency virus (HIV) negative or positive.
7) HIV positive patients on antiretroviral therapy regimen must be willing to suspend all Highly Active Antiretroviral Therapy (HAART) except in circumstances described in Section 6.5 of protocol
8) Eastern Cooperative Oncology Group (ECOG) 0-4
9) Ability of patient or durable power of attorney (DPA) for healthcare to give informed consent.
10) Hepatitis B + patients may be enrolled at the discretion of the investigator.
1) Patients with Primary CNS Lymphoma.
2) Inadequate renal function, defined as serum Cr > 1.5 mg/dl or creatinine clearance < 50 ml/min/1.73m^2 unless lymphoma related.
3) Inadequate hepatic or hematological function, as follows, unless lymphoma-/disease-related: bilirubin > 2 mg/dl (total) except > 5 mg/dl in patients with Gilbert’s syndrome as defined by > 80% unconjugated; Absolute Neutrophil Count (ANC) < 1000 and platelets < 75,000.
4) The effects of EPOCH-R on the developing human fetus are unknown. For this reason and because chemotherapy agents are known to be teratogenic. Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion will not be eligible to participate in the study.
5) Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without child-bearing potential.
6) The effects of EPOCH-R on the developing human fetus are unknown. For this reason and because chemotherapy agents are known to be teratogenic. Male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion will not be eligible to participate in the study.
7) History of a prior invasive malignancy in past 5 years.
8) Active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If echo is obtained the Left Ventricular Ejection Fraction (LVEF) should exceed 40%.
9) Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.
10) HIV positive patients with advanced immune suppression and evidence of HIV resistant to all combinations of antiretroviral therapy considered at high risk of non-lymphoma related death within 12-months due to other AIDS complications should not be enrolled on the study.
Information and next steps
Malignant neoplasms stated as primary lymphoid haematopoietic
Michelle A. Fanale
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