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

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.

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Key information

Conditions

T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Weill Medical College of Cornell University

New York, 10021, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHOP and alemtuzumab

Drug

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

Bayer

Registry information

Official study title

Phase I Study of CHOP Plus Campath (C-CHOP) for the Treatment of T-Cell, Null-Cell, and NK-Cell Lymphomas

Important dates

Study start: 2004
First posted: Sep 12, 2005
Registry last updated: Oct 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed