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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161590

Enrollment

Unknown

Registered

2005-09-12

Start date

2004-07-31

Completion date

Unknown

Last updated

2008-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

NK cell lymphoma, Null cell lymphoma

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.

Interventions

DRUGCHOP and alemtuzumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026