Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma

Weill Medical College of Cornell University

Overview

Primary Objective: * To determine the toxicity profile and tolerability of alemtuzumab (Campath) when administered in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy (C-CHOP) in patients with T-cell, null-cell and NK-cell lymphomas. Secondary Objectives: * To evaluate response rate, overall survival, and disease-free survival in patients with T-cell, null-cell, and NK-cell lymphomas treated with Campath + CHOP chemotherapy. * To assess the incidence of cytomegalovirus (CMV) reactivation in patients with these lymphomas treated with the Campath + CHOP combination. * To determine features which might be predictive of resistance to treatment or predictive of relapse, including the absence of glycosylphosphatidylinositol (GPI)-linked proteins.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

T-Cell Lymphoma Lymphoma, Non-Hodgkin's

Interventions

CHOP and alemtuzumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have a diagnosis of non-B-cell, non-Hodgkin's lymphoma (including T-cell, null-cell, or NK-cell lymphoma, but excluding lymphoblastic lymphoma) * Stage II, III, or IV disease requiring chemotherapy * At least one site of measurable disease, 1.5 cm in diameter or greater * Age \> or = 18 years * Absolute granulocyte count of at least 1500 cells/mm3, unless neutropenia is due to marrow infiltration by the tumor * Platelet count of at least 100,000 cells/mm3 unless thrombocytopenia is due to marrow infiltration by tumor * Creatinine less than 2 x upper limits of normal (ULN) * Total bilirubin less than 2 x ULN (dose reduced vincristine and adriamycin required for bilirubin \> 1.2 mg/dL) * Echocardiogram (Echo) or multiple gate acquisition scan (MUGA) documenting a normal ejection fraction prior to chemotherapy * Able to give informed consent Exclusion Criteria: * Known central nervous system (CNS) involvement * Known HIV disease * Patients who are pregnant or nursing * Any factor which might limit the patient's ability to provide informed consent * Life expectancy \< 3 months * Patients who are unwilling to agree to use an effective means of birth control while on treatment

Locations (1)

Weill Medical College of Cornell University

New York, New York, United States

Data from ClinicalTrials.gov

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