Status:
COMPLETED
Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Bayer
Conditions:
T-Cell Lymphoma
Lymphoma, Non-Hodgkin's
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00161590
Start Date
July 1 2004
Last Update
October 22 2008
Active Locations (1)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10021