This randomized phase II trial studies how well intravenous (IV) chemotherapy or oral chemotherapy works in treating patients with previously untreated stage III-IV human immunodeficiency virus (HIV)-associated non-Hodgkin lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, lomustine, etoposide, and procarbazine hydrochloride, 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
PRIMARY OBJECTIVES: I. To compare the efficacy of standard cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) and an oral chemotherapy regimen for acquired immune deficiency syndrome (AIDS)-related (AR)-non-Hodgkin lymphoma (NHL) in sub-Saharan Africa with respect to overall survival (OS). SECONDARY OBJECTIVES: I. To compare the objectives response rate (ORR) of persons randomized to CHOP and oral chemotherapy. II. To compare the progression free survival (PFS) of persons randomized to CHOP and oral chemotherapy. III. To compare the safety and tolerance of persons randomized to CHOP and oral chemotherapy. TERTIARY OBJECTIVES: I. To describe the rates of completion of therapy of persons randomized to CHOP and oral chemotherapy. II. To describe adherence to chemotherapy of persons randomized to CHOP and oral chemotherapy. III. To describe adherence to antiretroviral therapy of persons randomized to CHOP and oral chemotherapy. IV. To describe the effects of therapy on HIV control, as measured by cluster of differentiation (CD)4 counts and HIV viral load. V. To investigate correlates of survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive CHOP chemotherapy comprising cyclophosphamide intravenously (IV) on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone orally (PO) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive lomustine PO once daily (QD) on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Given IV
Given IV
Given IV
Given PO
Given PO
Given PO
Given PO
Given PO
Correlative studies
Moi Teaching and Referral Hospital
Eldoret, Kenya
University of Zimbabwe College of Health Sciences
Harare, Zimbabwe
Overall Survival
Proportion of participants who survived 2 years
Time frame: Up to 24 months
Overall Response Rate
Overall response is complete or partial response as defined by response definitions of the 2014 International Conference on Malignant Lymphoma Imaging Working Group (i.e. Lugano classification). Complete response is the disappearance of all lesions with no new lesions detected. Partial response is \>=50% decrease in the sum of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites and no new sites of disease.
Time frame: Up to 24 months
Progression-free Survival
Proportion of participants who survived without disease progression at 2 years
Time frame: Up to 24 months
Participants Who Experienced an Adverse Event
Number of participants who experienced an adverse event
Time frame: Up to 24 months
Number of Patients Who Complete Treatment
Number of patients who complete chemotherapy treatment.
Time frame: Up to 18 weeks
Proportion of Patients Who Are Adherent to Antiretroviral Therapy
Number of patients who did not miss any of their doses of antiretroviral therapy
Time frame: Up to 24 months
Proportion of Patients Who Are Adherent to Chemotherapy
Patients who did not miss any doses of chemotherapy
Time frame: Up to 18 weeks
Change in Absolute CD4 Count From Baseline to Post-treatment
Change in absolute CD4 count from baseline to post-treatment (visit 6)
Time frame: From baseline to 18 weeks
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