A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma
I. Determine the efficacy of monoclonal antibody SGN-30 in combination with
cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) in patients
with newly diagnosed anaplastic large cell lymphoma (ALCL).
II. Determine the safety of combining monoclonal antibody SGN-30 with CHOP chemotherapy.
I. Determine whether monoclonal antibody SGN-30 can induce apoptosis of ALCL cells in vivo.
II. Determine the response duration in patients treated with this regimen. III. Correlate
response with pretreatment serum CD30 levels. IV. Determine response to single-agent
monoclonal antibody SGN-30.
OUTLINE: This is a multicenter study. Patients are stratified according to anaplastic large
cell kinase (ALK) status (positive vs negative).
Monoclonal antibody SGN-30 monotherapy: Patients receive monoclonal antibody SGN-30 IV over
2 hours once weekly for 3 weeks.
Monoclonal antibody SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of
monoclonal antibody SGN-30 monotherapy, patients receive monoclonal antibody SGN-30 IV over
2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour,
doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1
and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (ORR) defined as the proportion of patients experiencing a complete or partial response to a regimen of SGN-3- + CHOP
An ORR of 80% or higher would be evidence of sufficient activity to warrant further study of this treatment combination. Descriptive statistics will be used to report results.
Up to 5 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|