Trial Information

CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]

OBJECTIVES:

Primary

- To determine the feasibility of adding alemtuzumab to standard cyclophosphamide,
doxorubicin hydrochloride, vincristine, and oral prednisolone (CHOP) chemotherapy in
patients with stage I-IV peripheral T-cell lymphoma (PTCL).

- To assess the side effect profile and early and late toxicities of this regimen in a
standard dose-escalation design, and to establish an appropriate dose level for future
studies.

Secondary

- To document response rates and disease-free survival of patients treated with this
regimen, and to compare these findings with those of historical controls.

- To monitor immune reconstitution after therapy.

- To determine the pharmacokinetics of subcutaneous alemtuzumab when given in combination
with CHOP chemotherapy.

- To more clearly define the CD52 expression profile in these tumors and to investigate
phenotypic variations in PTCL.

- To document changes (if any) in levels of Epstein-Barr virus copy number by polymerase
chain reaction during CHOP-alemtuzumab therapy.

OUTLINE: This is a multicenter, dose escalation of alemtuzumab study.

Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride
IV, and vincristine IV on day 1 and oral prednisone on days 1-5. Patients also receive
alemtuzumab subcutaneously (SC) 1-3 times a week for up to 6 doses per course. Treatment
repeats every 3 weeks for up to 8 courses in the absence of disease progression or
unacceptable toxicity.

Patients undergo blood collection at baseline, periodically during study treatment, and
after completion of study therapy for pharmacokinetics and other correlative studies to
monitor cellular immunity. Blood samples are examined by polymerase chain reaction to detect
cytomegalovirus antigen and to monitor Epstein-Barr virus copy number. Samples are also
analyzed by flow cytometry to quantify circulating B- and T-cells, NK-cells, monocytes, and
dendritic-cells.

After completion of study therapy, patients are followed every 3 months for the first year,
every 6 months for the second year, and then yearly thereafter.