Rituximab and Combination Chemotherapy in Treating Patients with CD20 Positive Diffuse Large B-Cell Lymphoma in Malawi

Status: complete

This phase I/II trial studies side effects of rituximab and combination chemotherapy in treating patients with CD20 positive diffuse large B-cell lymphoma living in Malawi. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab and combination chemotherapy may work better in treating patients with diffuse large B-cell lymphoma.

Inclusion Criteria

Informed consent obtained and signed
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Histologically confirmed CD20-positive DLBCL, any stage, bulky or nonbulky disease
No prior treatment for lymphoma
Willing to have documentation of HIV status
CD4 count >= 100 cells/uL if HIV-infected
Measurable disease by physical exam
Absolute neutrophil count (ANC) >= 1,000/uL
Platelet count >= 100,000/uL
Creatinine =< 1.5 mg/dL
Total bilirubin =< 2 mg/dL (unless directly attributable to lymphoma)
Able to understand and comply with protocol requirements for the entire length of the study
Willing to reside < 50 kilometers from Kamuzu Central Hospital (KCH) until chemotherapy completion
Negative urine beta-human chorionic gonadotropin (B-HCG) in women of child-bearing potential within 7 days prior to start of treatment
Fertile patients must use effective contraception (condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during and for six months after completion of treatment

Exclusion Criteria

Pregnant or nursing
Central nervous system (CNS) involvement by lymphoma (clinically or cytologically confirmed)
Receiving other anti-cancer or investigational therapy during study treatment, apart from those agents specified in the study protocol
Known cardiac disease including any of the following: * New York Heart Association (NYHA) grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 6 months prior to day 1 * History of stroke or transient ischemic attack within 6 months prior to day 1
Second active malignancy requiring systemic therapy
Hepatitis B virus (HBV) surface-antigen positive unless receiving both tenofovir and lamivudine as part of antiretroviral therapy if HIV-infected
Other serious, ongoing, non-malignant disease or infection that would in the opinion of the site investigator compromise other protocol objectives

PRIMARY OBJECTIVE:

I. To estimate the proportion of diffuse large B-cell lymphoma (DLBCL) patients receiving rituximab (R)-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) who experience National Cancer Institute (NCI) grade 3 or 4 non-hematologic toxicities and the proportion who experience treatment-related death over a course of six cycles.

SECONDARY OBJECTIVES:

I. To estimate the proportion of DLBCL patients by human immunodeficiency virus (HIV) status receiving R-CHOP who experience grade 3 or 4 non-hematologic toxicities over a course of six cycles.

II. To assess the achievable dose intensity for R- CHOP administered among DLBCL patients in Malawi with and without HIV infection.

III. To estimate progression-free survival (PFS), overall survival (OS), and complete response (CR) rates for R-CHOP administered among DLBCL patients in Malawi overall, and with and without HIV infection.

IV. To assess health-related quality of life (via the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30) among DLBCL patients in Malawi overall and with and without HIV infection receiving R-CHOP.

V. To perform cost-effectiveness modeling for rituximab plus CHOP chemotherapy administered for six cycles among DLBCL patients in Malawi, using locally derived clinical trial and cost data.

OUTLINE:

Patients receive cyclophosphamide intravenously (IV) over 30-60 minutes on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, prednisone orally (PO) once daily (QD) on days 1-5, and rituximab IV over 30 minutes on day 2. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who are tolerating treatment may receive up to 8 cycles if there is evidence of clinical benefit after 6 cycles.

After completion of study treatment, patients are followed up every 3 months for 24 months and then at 36, 48, and 60 months.

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Rituximab and Combination Chemotherapy in Treating Patients with CD20 Positive Diffuse Large B-Cell Lymphoma in Malawi

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