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)
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
Interventional
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.
1 year
No
Michael Millenson, MD, FACP
Principal Investigator
Fox Chase Cancer Center
United States: Institutional Review Board
OER-HM-039
NCT01539174
July 2013
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |