A Phase II Study of Rituximab Intense Dosing With CHOP-21 (RID-CHOP) in Patients With Previously Untreated High or High-Intermediate Risk IPI (3-5) Diffuse Large B-Cell Lymphoma (DLBCL)
I. To evaluate 1 year progression-free survival (PFS) following treatment with rituximab
intense dosing and CHOP-21 (RID-CHOP) in previously untreated patients with high risk
(International Prognostic Index [IPI] 3-5) DLBCL.
I. To evaluate, in previously untreated patients with high risk (IPI 3-5) DLBCL treated with
rituximab intense dosing and CHOP-21: Complete response (CR) rate, (as defined by
International Harmonization Project criteria using 18-fluorodeoxyglucose [FDG] -positron
emission tomography [PET]/computed tomography [CT]).
II. Overall survival.
III. Toxicity profile.
IV. Rituximab pharmacokinetics for this dose and schedule.
V. Effect of immunophenotype of DLBCL on outcome.
VI. Effect of Fc-Gamma Receptor III (FcyRIII) polymorphism genotype on outcome. OUTLINE:
Patients receive rituximab intravenously (IV) on days 0, 1, 4, 8, and 15 of course 1; days
1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP
chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine
sulfate IV on day 1, and prednisone orally (PO) on days 1-5. Treatment repeats every 21 days
for 6 courses in the absence of disease progression or unacceptable toxicity. After
completion of study treatment, patients are followed up every 2-3 months for 2 years, every
6 months for 3 years, annually for up to 10 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PFS following treatment with rituximab intense dosing and CHOP-21 in previously untreated patients with high risk DLBCL
Defined as the time from entry onto study until lymphoma progression or death from any cause.
Michael Millenson, MD, FACP
Fox Chase Cancer Center
United States: Institutional Review Board
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|