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

T-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161590
• Other study ID #: 0204-157
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2005
• Last updated: October 21, 2008
• Start date: July 2004

Study information

• Verified date: October 2008
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• CHOP and alemtuzumab

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Bayer

Country where clinical trial is conducted

United States,