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


Phase 2
12 Years
N/A
Open (Enrolling)
Both
Non Hodgkin's Lymphoma

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Trial Information

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


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.

Secondary:

Assess PFS in bcl-2 + lymphomas treated with dose-adjusted EPOCH-R, and determine if it is
significantly better than dose-adjusted EPOCH alone.

Obtain pilot information on the CR and PFS of dose-adjusted EPOCH with G-CSF in CD20
negative B cell lymphomas, anaplastic large cell lymphomas (ALCL) and peripheral T-cell
lymphomas (PTCL).

Assess toxicity of dose-adjusted EPOCH-Rituximab with G-CSF in agressive lymphomas.

Characterize the patterns of mdr-1, bcl-2, MIB-1 and mutant p53 expression in previously
untreated lymphoma patients.

Assess the effect of EPOCH-R on ovarian function and reserve in female patients with PMBL.

Eligibility:

Non-Hodgkin's lymphomas in the following categories: diffuse large B-cell to include

gray zone lymphoma and follicular center cell grade IIIB, anaplastic large cell, aggressive

T-cell lymphomas and Burkitt Lymphoma.

Patients greater than or equal to 12 years old.

Stages II, III, IV for all subtypes, and Stage I for bulky (> 5 cm) primary mediastinal

lymphomas or Burkitt Lymphoma.

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 318 patients will be enrolled on this protocol at 5 different participating
centers.

Inclusion Criteria


- INCLUSION CRITERIA:

Non-Hodgkin's lymphomas in the following categories: diffuse large B cell to include gray
zone lymphoma and follicular center cell grade IIIB, anaplastic large cell, and aggressive
T-cell lymphomas and Burkitt Lymphoma.

Patients with evidence of an underlying low-grade lymphoma will not be eligible for this
study. This includes patients who have both indolent and aggressive histologies in the
same or different biopsy sites (e.g. large cell lymphoma in a node and follicular center
cell lymphoma in the bone marrow).

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: Stages II, III, IV for all subtypes, and stage I bulky
(greater than 5 cm) primary mediastinal B-cell lymphomas or Burkitt Lymphoma.

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 cervix cancer.

Ability to give informed consent.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response after completion of study treatment

Safety Issue:

No

Principal Investigator

Wyndham H Wilson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

930133

NCT ID:

NCT00001337

Start Date:

April 1993

Completion Date:

March 2015

Related Keywords:

  • Non Hodgkin's Lymphoma
  • Open-Label
  • Non-Randomized
  • Pilot
  • Primary Mediastinal B-Cell Lymphoma
  • CD20 +
  • Diffuse Large B-Cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • De Novo
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892