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

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