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

Phase 1

Completed

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

• Registration Number: NCT00161590
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-21
• Last Update Posted: 2008-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States