Stage IV Adult Diffuse Large Cell Lymphoma Clinical Trial
Official title:
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)
This phase II trial studies how well giving rituximab together with combination chemotherapy works in treating patients with previously untreated high- or high-intermediate-risk diffuse large B-cell lymphoma (DLBCL). Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells. Giving rituximab together with combination chemotherapy together may be an effective treatment for 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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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