NCT00161590CompletedPhase 1
Phase I Study of CHOP Plus Campath (C-CHOP) for the Treatment of T-Cell, Null-Cell, and NK-Cell Lymphomas
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Locations
- 1
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Study Sites (1)
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