Brief Title
Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma
Official Title
Phase I Study of CHOP Plus Campath (C-CHOP) for the Treatment of T-Cell, Null-Cell, and NK-Cell Lymphomas
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
T-Cell Lymphoma
Intervention
CHOP and alemtuzumab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
July 2004
Eligibility 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
Gender
All
Ages
18 Years - N/A
Contacts
Richard Furman, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00161590
Organization ID
0204-157
Study Sponsor
Weill Medical College of Cornell University
Collaborators
Bayer
Study Sponsor
Richard Furman, MD, Principal Investigator, Weill Medical College of Cornell University
Verification Date
October 2008