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Pilot Trial of Alemtuzumab and Dose-Adjusted Epoch in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas


Phase 2
17 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Pilot Trial of Alemtuzumab and Dose-Adjusted Epoch in Chemotherapy Naive Aggressive T and NK-Cell Lymphomas


Background:

The paradigm of combining therapeutic agents with non-overlapping toxicities for the
treatment of malignancy produces clinical remissions and cures in a number of tumor types.

A new class of agents, humanized and chimerized monoclonal antibodies, typically have little
or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic
chemotherapy. It has become clear that in certain lymphomas and breast cancers, the
combination of monoclonal antibodies and chemotherapy improves response rate and the quality
of the response compared with that achieved by treatment with either agent alone.

The clinical outcome for patients with T-cell non-Hodgkin's lymphoma is significantly
inferior to the outcome of patients with B-cell non-Hodgkin's lymphoma. In most reports less
than 20% of patients with T cell lymphoid malignancies remain free of disease at 5 years.

Objectives:

Determine the toxicity of Alemtuzumab and EPOCH chemotherapy in untreated CD52-expressing T
and NK lymphoid malignancies.

Determine the maximum tolerated dose of Alemtuzumab administered in combination with EPOCH
chemotherapy.

Determine in a preliminary fashion the anti-tumor activity of the combination of Alemtuzumab
and EPOCH chemotherapy.

Eligibility:

CD52-expressing lymphoid malignancy.

Patients with chemotherapy naive aggressive T & NK lymphomas. Patients with alk-positive
anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible.

Age greater than or equal to 17 years.

Adequate organ function, unless impairment due to respective organ involvement by tumor.

No active symptomatic ischemic heart disease, myocardial infarction or congestive heart.
failure within the past year.

HIV negative.

Not pregnant or nursing.

Design:

Three dose levels of Alemtuzumab will be evaluated to determine the toxicity profile and in
a preliminary fashion the antitumor activity of the combination with Dose-Adjusted EPOCH.

Three dose levels of Alemtuzumab will be explored, in cohorts of three to six patients each.
Patients will receive either 30, 60, or 90 mg of Alemtuzumab on day 1 of therapy, followed
by dose-adjusted EPOCH chemotherapy days 1-5.

Inclusion Criteria


- ELIGIBILITY CRITERIA:

CD52-expressing lymphoid malignancy, confirmed by pathology or flow cytometry staff of the
Hematopathology Section, Laboratory of Pathology, NCI. Patients with T & NK cell
malignancy without accessible tissue for flow cytometry analysis may be treated on this
study.

Patients with chemotherapy naive aggressive T & NK lymphomas, including but not limited
to peripheral T cell lymphoma (nos), gamma-delta hepatosplenic T cell lymphoma,
subcutaneous panniculitis-like T cell, NK-T cell lymphoma confirmed by pathology or flow
cytometry staff of the Hematopathology Section, Laboratory of Pathology, NCI. Patients
with alk-positive anaplastic large cell lymphoma and patients with T cell precursor
disease are not eligible.

Age greater than or equal to 17 years.

Laboratory tests: Creatinine less than or equal to 1.5 mg/dL or creatinine clearance
greater than or equal to 60 ml/min; bilirubin less than 2.0 mg/dl unless due to Gilbert's,
AST and ALT less than or equal to 3 times ULN (AST and ALT is less than or equal to 6
times ULN for patients on hyperalimentation for whom these abnormalities are felt to be
due to the hyperalimentation) and; ANC is greater than or equal to 1000/mm(3), platelet
greater than or equal to 75,000/mm(3); unless impairment due to respective organ
involvement by tumor.

No active symptomatic ischemic heart disease, myocardial infarction or congestive heart
failure within the past year.

HIV negative, because of the unknown effects of combined therapy with chemotherapy and an
immunosuppressive agent on HIV progression.

Signed informed consent.

Willing to use contraception.

Not pregnant or nursing, because of the unknown effects of Alemtuzumab on the developing
fetus and infant.

No serious underlying medical condition or infection that would contraindicate treatment.
Patients with CNS involvement are eligible for treatment on this study.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Determine the toxicity of Alemtuzumab and EPOCH chemotherapy in untreated CD52-expressing T and NK lymphoid malignancies.

Principal Investigator

Wyndham H Wilson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

030304

NCT ID:

NCT00069238

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • Immunosuppression
  • CD52
  • Flow Cytometry
  • Campath 1-H
  • Lymphoma
  • T-Cell Lymphoma
  • NK -Cell Lymphoma
  • Lymphoma

Name

Location

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