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

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 1

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

Treatments: Drug: CHOP and alemtuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00161590

0204-157

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)