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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Bayer
• Treatments: Alemtuzumab

Criteria

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