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

NCT00161590 | Completed Phase 1

• 1 other identifier: 0204-157
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NK cell lymphoma; Null cell lymphoma

Interventions

CHOP and alemtuzumab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Bayer: collaborator

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Richard Furman, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2004
• Last Updated: October 22, 2008

Record last verified: 2008-10

Locations

US (1)