Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma

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.