Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma

• Status: Active, not recruiting
• Trial end date: 2024-07-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish the safety of rituximab plus cyclophosphamide, doxorubicin, vincristine,prednisone (R-CHOP) in HIV-infected and HIV-uninfected diffuse large B-cell lymphoma (DLBCL) patients in Malawi.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Fogarty International Center of the National Institute of Health; John E. Fogarty International Center (FIC); National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Informed consent obtained and signed. Age 18-60 years. 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/µL if HIV-infected. Measurable disease by physical exam.

• Adequate bone marrow renal and hepatic function as evidenced by the following:

• Absolute neutrophil count (ANC) ≥ 1,000/µL

• Platelet count ≥ 100,000/µL

• 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 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.