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

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Study of CHOP Plus Campath (C-CHOP) for the Treatment of T-Cell, Null-Cell, and NK-Cell Lymphomas

Conditions
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T-Cell Lymphoma, Lymphoma, Non-Hodgkin's

Intervention / Treatment
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* Drug: CHOP and alemtuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CHOP and alemtuzumab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK cell lymphoma, Null cell lymphoma