Clinical Trials /

Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma

NCT00001337

Description:

5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. EPOCH: Etoposide, VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen), G-CSF, NSC-614629.

Related Conditions:
  • Mediastinal B-Cell Lymphoma, Unclassifiable, with Features Intermediate between Diffuse Large B-Cell Lymphoma and Classical Hodgkin Lymphoma
  • Primary Mediastinal B-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
  • Official Title: Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Adults and Children With Previously Untreated Patients With Aggressive Non-Hodgkin's Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 930133
  • SECONDARY ID: 93-C-0133
  • NCT ID: NCT00001337
  • NCT ALIAS: NCT00018980

Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Primary Mediastinal Large B-cell Lymphoma
  • Burkitt Lymphoma
  • Anaplastic Large-Cell Lymphoma
  • Gray Zone Lymphoma

Interventions

DrugSynonymsArms
EPOCHArm A
RituximabArm A

Purpose

5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. EPOCH: Etoposide, VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen), G-CSF, NSC-614629.

Detailed Description

      Background:

      The treatment of the intermediate and aggressive non-Hodgkin's lymphomas in adults and
      children commonly induces complete responses in a sizable fraction of the treated population,
      and about 2/3 of the complete responders appear to have prolonged disease-free survival.

      The present study assesses the activity and tolerability in previously untreated patients of
      a regimen of EPOCH infusional chemotherapy given intensively with G-CSF support.

      Objectives:

      Primary:

      Assess complete response (CR) and progression-free survival (PFS) of dose-adjusted
      EPOCH-Rituximab (DA-EPOCH-R) with G-CSF in agressive B-cell lymphomas.

      Eligibility:

      Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma (MGZL)
      and primary mediastinal B cell lymphoma (PMBL).

      Patients greater than or equal to 12 years old.

      Any Stage for PMBL and MGZL.

      No prior systemic chemotherapy.

      HIV negative.

      Design:

      This study will estimate the complete response rate of a group of previously untreated
      patients and the extent to which EPOCH infusional drug delivery accompanied by a
      hematopoietic growth factor can increase the dose intensity of treatment.

      Patients receive prednisone orally for 5 days, a 96 hour infusion of vincristine,
      doxorubicin, and etoposide, and a bolus of cyclophosphamide on day 5.

      Cycles are repeated every 21 days for a total of 6-8 cycles.

      Patients with CD20 expressing tumors (i.e. mature B-cell lymphomas) will also receive
      rituximab, the humanized monoclonal antibody against the CD20 receptor on day 1 of each
      cycle.

      A total of 348 patients will be enrolled on this protocol.
    

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalEPOCH + Rituximab every 3 weeks for 6 cycles.
  • EPOCH
  • Rituximab

Eligibility Criteria

        -  INCLUSION CRITERIA:

        Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma and
        primary mediastinal B cell

        lymphoma.

        Diagnosis confirmed by staff of the Hematopathology Section, Laboratory of Pathology, NCI.
        Tissue blocks from patients treated in extramural sites must be forwarded to the NCI for
        analysis of bcl-2 by IHC and other markers within 1 month of study entry.

        Patients greater than or equal to 12 years old.

        Stage and Prognosis of Patients: Any stage for MGZL and PMBL.

        No prior systemic chemotherapy. Patients may be entered if they have had prior
        limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for
        an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava
        syndrome).

        HIV negative.

        Not pregnant or nursing.

        Adequate major organ function [in adults: serum creatinine less than or equal to 1.5 mg/dl
        or creatinine clearance greater than 60 ml/min; and in children serum CR less than or equal
        to age-adjusted normal (age 12 to 15 maximum serum creatinine 1.2 mg/dl and age greater
        than 15 maximum serum creatinine 1.5 mg/dl); bilirubin less than 1.5 mg/dl; ANC greater
        than 1,000 and platelets greater than 100,000) unless impairment is due to organ
        involvement by lymphoma or immune-mediated mechanism caused by lymphoma.

        No active symptomatic ischemic heart disease, myocardial infarction or congestive heart
        failure within the past year. If MUGA is obtained, the LVEF should exceed 40%.

        No other serious concomitant medical illnesses or uncontrolled active infection that would
        jeopardize the patient's ability to receive the regimen with reasonable safety.

        No history of unrelated (non-lymphomatous) neoplasms within past 5 years other than
        non-melanoma skin cancer or in-situ cancer.

        Ability to give informed consent.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response and PFS
Time Frame:Time of progression
Safety Issue:
Description:The Dixon-Simon method will be used to determine whether large B-cell lymphomas expressing BCL-2 (+) patients may experience an improved progression free survival with EPOCH-R compared to EPOCH alone, and to obtain a concurrent, precisely determined measure of progression free survival.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Cancer Institute (NCI)

Trial Keywords

  • Primary Mediastinal B-Cell Lymphoma
  • CD20 +
  • Diffuse Large B-Cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • De Novo

Last Updated

February 27, 2020