Details

Details

Title Phase II Study of Dose-Adjusted EPOCH Rituximab in Adults with Untreated Burkitt Lymphoma, C-Myc Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma

IRB NCI1412

CC 12-721

Hospital Main Campus

Phase Phase 2

Disease Lymphoma, Lymphoma - Hodgkin, Lymphoma - Non - Hodgkin

Drug EPOCH, Rituximab

Description

Description

Primary
  1. Determine PFS, EFS and OS of risk adaptive DA-EPOCH-R in newly diagnosed Burkitt Lymphoma, c-MYC + DLBCL and DA-EPOCH in c-MYC+ plasmablastic lymphoma ≥ 18 years.
Secondary
  1. Assess predictive value of early FDG-PET/CT scans on PFS.
  2. Obtain pilot comparative molecular profiling of 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.
Inclusion Criteria

Inclusion Criteria

  1. Patients must have 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. 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.
  8. 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.
Exclusion Criteria

Exclusion Criteria

  1. Patients with Primary CNS Lymphoma
  2. Inadequate renal function, defined as serum Cr > 1.5 mg/dL or creatinine clearance < 50 ml/min/1.73m2 unless lymphoma related.
  3. Inadequate hepatic or hematological function: bilirubin > 2 mg/dl (total) except > 5 mg/dl in patients with Gilbert syndrome as defined by > 80% conjugated; ANC < 1000 and platelets < 75,000 unless lymphoma related.
  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 B-human chorionic gonadotropin (BhCG) 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 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.