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

Primary Purpose

T-Cell Lymphoma, Lymphoma, Non-Hodgkin's

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CHOP and alemtuzumab
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-Cell Lymphoma focused on measuring NK cell lymphoma, Null cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Weill Medical College of Cornell University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 7, 2005
Last Updated
October 21, 2008
Sponsor
Weill Medical College of Cornell University
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00161590
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Bayer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-Cell Lymphoma, Lymphoma, Non-Hodgkin's
Keywords
NK cell lymphoma, Null cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CHOP and alemtuzumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Furman, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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