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

Completed · Phase 1

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

In brief

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.

Key facts

Study ID

NCT00161590

Run by

Weill Medical College of Cornell University

Starts

2004-07-01

Last updated by the study team

2008-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Weill Medical College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

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