Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma
NCT ID: NCT00161590
Last Updated: 2008-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2004-07-31
Brief Summary
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* 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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CHOP and alemtuzumab
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Weill Medical College of Cornell University
OTHER
Principal Investigators
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Richard Furman, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Medical College of Cornell University
New York, New York, United States
Countries
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Other Identifiers
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0204-157
Identifier Type: -
Identifier Source: org_study_id