Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated High- or High-Intermediate-Risk Diffuse Large B-Cell Lymphoma

Conditions

• Contiguous Stage II Adult Diffuse Large Cell Lymphoma
• Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
• Stage I Adult Diffuse Large Cell Lymphoma
• Stage III Adult Diffuse Large Cell Lymphoma
• Stage IV Adult Diffuse Large Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab — BIOLOGICAL
  Given IV
• cyclophosphamide — DRUG
  Given IV
• doxorubicin hydrochloride — DRUG
  Given IV
• vincristine sulfate — DRUG
  Given IV
• prednisone — DRUG
  Given PO
• laboratory biomarker analysis — OTHER
  Correlative studies
• pharmacological study — OTHER
  Correlative studies

Study Details

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

Key Dates

Status verified

Mar 2016

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (monoclonal antibody, combination chemotherapy)
  Patients receive rituximab 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 PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

PFS following treatment with rituximab intense dosing and CHOP-21 in previously untreated patients with high risk DLBCL [ Time Frame: 1 year ]

Locations (1)

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